A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study
Phase: PHASE3
Conditions: COVID-19, SARS-CoV2
Sponsor: Eli Lilly and Company

Pr ot oc ol : J 2 X- M C- P Y A D( d)
A P hase 3 Ra n d o mize d, D o u ble- Bli n d, Place b o- C o ntr olle d Trial t o E val uate t he Efficac y 
a n d Safet y of L Y 3 8 1 9 2 5 3 Al o ne a n d i n C o m bi nati o n Wit h L Y 3 8 3 2 4 7 9 i n Pre ve nti n g 
S A R S- C o V- 2 I nfecti o n a n d C O VI D- 1 9 i n S kille d N ursi n g a n d Assiste d Li vi n g Facilit y 
Resi de nts a n d Staff; a NI AI D a n d Lill y C olla b orati ve St u d y
N C T 0 4 4 9 7 9 8 7
A p pr o val Date: 2 2-Ja n- 2 0 2 1

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1
Title P a ge
C o nfi d e nti al I nf or m ati o n
T h e i nf or m ati o n c o nt ai n e d i n t hi s d o c u m e nt i s c o nfi d e nti al a n d i s i nt e n d e d f or t h e u s e of cli ni c al i n v e sti g at or s.  It i s t h e pr o p ert y of 
Eli Lill y a n d C o m p a n y or it s s u b si di ari e s a n d s h o ul d n ot b e c o pi e d b y or di stri b ut e d t o p er s o n s n ot i n v ol v e d i n t h e cli ni c al 
i n v e sti g ati o n of L Y 3 8 1 9 2 5 3 , u nl e s s s u c h p er s o n s ar e b o u n d b y a c o nfi d e nti alit y a gr e e m e nt wit h Eli Lill y a n d C o m p a n y or it s 
s u b si di ari e s.  
N ot e t o R e g ul at or y A ut h oriti e s:   T hi s d o c u m e nt m a y c o nt ai n pr ot e ct e d p er s o n al d at a a n d/ or c o m m er ci all y c o nfi d e nti al 
i nfor m ati o n e x e m pt fr o m p u bli c di s cl o s ur e.  Eli Lill y a n d C o m p a n y r e q u e st s c o n s ult ati o n r e g ar di n g r el e a s e/r e d a cti o n pri or t o a n y 
p u bli c r el e a s e.  I n t h e U nit e d St at e s, t hi s d o c u m e nt i s s u bj e ct t o Fr e e d o m of I nf or m ati o n A ct ( F OI A) E x e m pti o n 4 a n d m a y n ot b e 
r epr o d u c e d or ot h er wi s e di s s e mi n at e d wit h o ut t h e writt e n a p pr o v al of Eli Lill y a n d C o m p a n y or it s s u b si di ari e s.
Pr ot oc ol Title: A P hase 3 Ra n d o mize d, D o u ble -Bli n d, Place b o -C o ntr olle d Trial t o E val uate t he 
Efficac y a n d Safet y of  L Y 3 8 1 9 2 5 3 alo n e a n d in c o m bi nat i on wi t h L Y 3 8 3 2 4 7 9 i n 
Pre ve nt i n g S A R S -C o V - 2 i nfecti on a n d C O VI D - 1 9 i n S kille d N ursi n g a n d 
Assiste d Li vi n g Facilit y Resi de nts a n d Staff ; a NI AI D a n d Lill y C olla b orati ve 
St u d y
Pr ot oc ol N u m ber: J 2 X-M C -P Y A D ; C o V P N # 3 5 0 1
A me n d me nt N u m ber: d
C o m p o u n d: L Y 3 8 1 9 2 5 3
St u d y P h ase: 3
S h ort Title: A St u d y  t o E v aluate L Y 3 8 1 9 2 5 3 alo ne a n d i n c o m bi nati on wi t h L Y 3 8 3 2 4 7 9 f or t he 
Pre ve nt i on of S A R S -C o V -2 i nfect i on a n d C O VI D - 1 9; a NI AI D a n d Lill y 
C olla b orati ve St u d y
S p o ns or N a me: El i Lill y  a n d C o mpa n y
Le g al Re gistere d A d dress: I n dia na p olis, I n dia na, U S A 4 6 2 8 5
Re g ul at or y A ge nc y I de ntifier N u m ber(s)
I N D: 1 5 0 4 4 0
A p pr o v al D ate: Pr ot oc ol A me n d me nt ( d ) El ectr o nicall y Si g ne d a n d A p pr o ve d b y Lill y o n date 
pr o vi de d bel o w.
A p pr o v al D at e: 2 2- J a n- 2 0 2 1 G M T

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
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Medical Monitor Name and Contact Information will be provided separately.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
3
Protocol Amendment Summary of Changes Table
DOCUMENT HISTORY
Document
Date
Amendment (c)
04 Dec 2020
Amendment (b)
06 Nov 2020
Amendment (a)
27 Oct 2020
Original Protocol
28 Jun 2020
Amendment d
Overall Rationale for the Amendment:
This amendment will allow participants with COVID-19 to enroll in Part 3 (treatment only) of
Study PYAD who have recovered from prior COVID-19 infection, or have received prior 
administration of convalescent plasma, monoclonal antibody, or vaccine for SARS-CoV-
2. Inclusion will allow for collection of data to explore safety of treatment of LY3819253 alone 
or in combination with LY3832479 in any of these participant populations. 
Section # and Name
Description of Change
Brief Rationale
Section 1.3.1 Part 1 and 
Prevention Cohort of 
Part 2
Updated “Prior treatments of special 
interest” to collect prior use of 
SARS-CoV-2 vaccine.
The SARS-CoV-2 vaccine is now allowed.
Section 1.3.2 Part 2 
Treatment Cohort and 
Part 3
2.2 Background
Added background on PYAB interim 
results.
Emerging data.
2.3 Benefit/Risk 
Assessment
Updated risk information for 
LY3819253.
Emerging data.
4.2 Scientific Rationale 
for Study Design
Added rationale for participants who
have received the SARS-CoV-2 
vaccine.
Added language for Part 3 to reflect 
that participants who were in 
independent living situations at the 
facilities could be enrolled.
Vaccines are now available to the public and 
those who received a vaccine are allowed in 
the study.
Clarification.
5.2 Exclusion Criteria
Updated Criteria 7, 8, 9, 11, 12, and 
13.
This amendment will allow participants with 
COVID-19 to enroll in Part 3 (treatment 
only) of the study having recovered from 
prior COVID-19 infection, or having 
received prior administration of convalescent 
plasma, monoclonal antibody, or vaccine for 
COVID-19. Inclusion will allow for 
collection of data to explore safety of 
treatment of LY3819253 alone or in 
combination with LY3832479 in any of these 
participant populations.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
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Section # and Name
Description of Change
Brief Rationale
6.3 Measures to 
Minimize Bias: 
Randomization and 
Blinding
Added stratification factor for 
whether a participant received a 
vaccine or not prior to screening
The SARS-CoV-2 vaccine is now allowed
11 References
Added Chen et al. 2020 reference
Source for information in Section 2.3

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
5
T a ble of C o nte nts
1.
Pr ot oc ol S u m m ar y ......................................................................................................8
1. 1.
S y n o psis .......................................................................................................................8
1. 2.
Sc he ma .......................................................................................................................1 5
1. 3.
Sc he d ule of Act i vities ( S o A) ......................................................................................1 7
1. 3. 1.
Part 1 a n d Pre ve nt i on C o h ort of Part 2 ........................................................................1 7
1. 3. 2.
Part 2 Treat me nt C o h ort a n d Part 3 .............................................................................2 4
2.
I ntr o d ucti o n ..............................................................................................................2 8
2. 1.
St u d y  Ratio nale ..........................................................................................................2 8
2. 2.
Bac k gr o u n d ................................................................................................................2 8
2. 3.
Be nefit/ Ris k Assess me nt ............................................................................................2 9
3.
O bjecti ves a n d E n d p oi nts .........................................................................................3 1
4.
St u d y Desi g n .............................................................................................................3 7
4. 1.
O verall Desi g n ............................................................................................................3 7
4. 1. 1. 
Scree ni n g Peri o d .........................................................................................................3 7
4. 1. 2.
E val uat i on Peri o d .......................................................................................................3 7
4. 1. 3. 
F ol l ow- u p Peri o d ........................................................................................................4 0
4. 2.
S ci e nt ific Rati o nale f or St u d y Desi g n.........................................................................4 1
4. 3.
J ustificati o n f or D ose..................................................................................................4 2
4. 4.
E n d of St u d y  Defi niti on ..............................................................................................4 2
5.
St u d y P o p ul ati o n ......................................................................................................4 3
5. 1.
I ncl usi on Cri t eria ........................................................................................................4 3
5. 2.
E xcl u sio n  Crit eria .......................................................................................................4 4
5. 3.
Lifest yle C o nsi derat i ons .............................................................................................4 4
5. 4.
Scree n Fail ures ...........................................................................................................4 4
6.
St u d y I nt er ve nti o n ....................................................................................................4 6
6. 1.
St u d y  I nter ve nti on(s) A d mi nistere d ............................................................................4 6
6. 1. 1.
S peci al Treat me nt C o nsiderat i ons ...............................................................................4 7
6. 2.
Pre parati o n/ Ha n dli n g/ St ora ge/ Acc o u nta bilit y .............................................................4 8
6. 3.
Meas ures t o Mi ni mize Bias: Ra n d o mizat i on a n d Bli n di n g ..........................................4 8
6. 4.
St u d y  I nter ve nti on C o m plia nce ...................................................................................5 0
6. 5.
C o nc o mita nt T hera p y ................................................................................................. 5 0
6. 6.
I nter ve nti o n after t he E n d of t he St u d y........................................................................5 1
7.
Disc o nti n u ati o n of St u d y I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al ....................................................................................5 2
7. 1.
Di sc o nti n uatio n of  St u d y I nter ve nti on ........................................................................5 2
7. 2.
P arti cipa nt Disc o nti n uati o n/ Wit h dra wal fr o m t he St u d y .............................................5 2
7. 2. 1.
Di sc o nti n uatio n of  I na d verte ntl y Enr olle d Partici pa nts ...............................................5 2
7. 3.
L ost t o F oll o w u p .......................................................................................................5 3
8.
St u d y A ssess me nts a n d Pr oce d ures .........................................................................5 4
8. 1.
Efficac y Assess me nts ................................................................................................. 5 4
8. 1. 1.
S A R S -C o V -2 Vi ral S wa b a n d Ser ol o g y......................................................................5 4
8. 1. 2.
P arti cipa nt S y m pt o m s Q uesti on naire ..........................................................................5 4

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
6
8. 2.
S af et y Assess me nts ....................................................................................................5 5
8. 2. 1.
P h ysical E xa mi nat i ons, Cli nical Si g ns a n d S y m pt o ms ................................................5 5
8. 2. 2.
Vi t al Sig ns.................................................................................................................. 5 5
8. 2. 3.
Cli nical Safet y  La b orat or y Assess me nts .....................................................................5 6
8. 2. 4.
H os pitalizati o n e ve nts ................................................................................................. 5 6
8. 2. 5.
Pr oce d ures of S pecial I nterest .....................................................................................5 7
8. 3.
A d verse E ve nts a n d Seri o us A d verse E ve nts ..............................................................5 7
8. 3. 1.
Ti me Peri o d a n d Fre q ue nc y  for C ollect i n g A E a n d S A E 
I nf or mat i on .................................................................................................................5 7
8. 3. 2.
Met h o d of Detecti n g A Es a n d S A Es ...........................................................................5 8
8. 3. 3.
F o ll ow- u p of  A Es a n d S A Es.......................................................................................5 8
8. 3. 4.
Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es............................................................5 8
8. 3. 5.
Pre g na nc y ...................................................................................................................5 8
8. 3. 6.
H y perse nsi tivi t y R e a ctio ns .........................................................................................5 8
8. 3. 7.
I nf usi on- r elate d Reactio ns .......................................................................................... 5 9
8. 3. 8.
Pr o d uct C o m plai nt s ....................................................................................................5 9
8. 4.
Treat me nt of O ver d ose ...............................................................................................6 0
8. 5.
P har mac o ki net ics........................................................................................................6 0
8. 5. 1.
Bi oa nal y tic al ..............................................................................................................6 1
8. 6.
P har mac o d y na mics .....................................................................................................6 1
8. 7.
Ge net ics .....................................................................................................................6 1
8. 8.
Bi o m ar kers .................................................................................................................6 1
8. 9.
I mm u n o ge nicit y Assess me nts .....................................................................................6 2
8. 1 0.
Heal t h Ec o n o mics.......................................................................................................6 2
9.
St atistic al C o nsi der ati o ns .........................................................................................6 3
9. 1.
Stati stical H y p ot heses................................................................................................. 6 3
9. 2.
S a mple Si ze Deter mi nat i on .........................................................................................6 3
9. 3.
P o p ul at i ons f or A nal yses ............................................................................................6 4
9. 4.
Stati stical A nal yses .....................................................................................................6 6
9. 4. 1.
Ge neral C o nsi derati o ns ...............................................................................................6 6
9. 4. 2.
P arti cipa nt Dis p osi tio n ................................................................................................6 7
9. 4. 3.
P arti cipa nt C haracteristics ...........................................................................................6 7
9. 4. 4.
C o nc o mita nt T hera p y ................................................................................................. 6 7
9. 4. 5.
Pri mar y E n d p o i nt........................................................................................................6 7
9. 4. 6.
Sec o n dar y  En d p o i nts ..................................................................................................6 8
9. 4. 7.
E x pl or at or y  E n d p oi nts ................................................................................................6 9
9. 4. 8.
Ot her Safet y A nal yses ................................................................................................6 9
9. 4. 9.
I mm u n o ge nicit y A nal yses ...........................................................................................6 9
9. 5.
I nteri m A nal yses.........................................................................................................7 0
9. 6.
Data M o nit ori n g C o m mittee ( D M C) ...........................................................................7 0
1 0.
S u p p orti n g D oc u me nt ati o n a n d O per ati o n al C o nsi der ati o ns ................................7 1
1 0. 1.
A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht 
C o nsi derati o ns ............................................................................................................7 1
1 0. 1. 1.
Re g ulat or y  a n d Et hical C o nsi derati ons ........................................................................7 1
1 0. 1. 2.
Fi na ncial Discl o s ure ...................................................................................................7 1
1 0. 1. 3.
I nf or me d C o nse nt Pr ocess ..........................................................................................7 2

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
7
1 0. 1. 4.
Data Pr otecti o n ...........................................................................................................7 2
1 0. 1. 5.
C o m mittees Str uct ure ................................................................................................. 7 3
1 0. 1. 6.
Di sse mi nati on of Cli nical St u d y  Data .........................................................................7 3
1 0. 1. 7.
Data Q ualit y Ass ura nce ..............................................................................................7 3
1 0. 1. 8.
S o urce D oc u me nts ......................................................................................................7 4
1 0. 1. 9.
St u d y  a n d Site Start a n d Clos ure .................................................................................7 5
1 0. 1. 1 0. P u blicat i on P olic y .......................................................................................................7 5
1 0. 1. 1 1. I n vesti gat or I nf or mati on .............................................................................................7 5
1 0. 1. 1 2. L o n g -Ter m  Sa m ple Rete nti on .....................................................................................7 5
1 0. 2.
A p pe n di x 2: Cli nical La b orat or y  Tests........................................................................7 7
1 0. 3.
A p pe n di x 3: A d verse E ve nts: Defi nit i ons a n d Pr oce d ures f or 
Rec or di n g, E val uat i n g, F oll o w-u p, a n d Re p orti n g .......................................................8 0
1 0. 3. 1.
Defi nit i on o f A E .........................................................................................................8 0
1 0. 3. 2.
Defi nit i on o f S A E .......................................................................................................8 1
1 0. 3. 3.
Rec or di n g a n d F o ll ow- U p of A E a n d/ or S A E .............................................................8 2
1 0. 3. 4.
Re p orti n g of S A Es ......................................................................................................8 4
1 0. 4.
A p pe n di x 4: C o ntrace pti ve G ui da nce a n d C o llecti o n of 
Pre g na nc y I nf or mati o n ...............................................................................................8 5
1 0. 4. 1.
W o me n .......................................................................................................................8 5
1 0. 4. 2.
Me n ............................................................................................................................8 6
1 0. 4. 3.
C ollect i on of Pre g na nc y  I nfor m at i on ..........................................................................8 7
1 0. 5.
A p pe n di x 5: Ge neti cs ................................................................................................. 8 8
1 0. 6.
A p pe n di x 6: Rec o m me n de d La b orat or y Test i n g f or 
H y perse nsi tivi t y E ve nts..............................................................................................8 9
1 0. 7.
A p pe n di x 7: Li ver Safet y:  S u g geste d Acti o ns a n d F oll o w- u p 
Assess me nts ...............................................................................................................9 1
1 0. 8.
A p pe n di x 8: A b bre viat i ons .........................................................................................9 5
1 0. 9.
A p pe n di x 9: Pr ot oc ol A me n d me nt Hist or y ................................................................. 9 8
1 1.
Refere nces ...............................................................................................................1 0 8

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
8
1.
Protocol Summary
1.1.
Synopsis
Protocol Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the 
Efficacy and Safety of LY3819253 alone and in combination with LY3832479 in Preventing 
SARS-CoV-2 infection and COVID-19 in Skilled Nursing and Assisted Living Facility
Residents and Staff; a NIAID and Lilly Collaborative Study
Short Title: A Study to Evaluate LY3819253 alone and in combination with LY3832479 for the 
Prevention of SARS-CoV-2 infection and COVID-19; a NIAID and Lilly Collaborative Study
Rationale:
The efficient community spread of SARS-CoV-2 has resulted in the current pandemic of 
Coronavirus Disease – 2019 (COVID-19), which in severe and critical cases results in 
progressive pulmonary infection, complicated by respiratory failure, with a high prevalence of 
acute respiratory distress syndrome.  Of all age groups, older adults have the greatest risk of 
severe COVID-19 and the associated complications (CDC 2020; Grabowski and Mor 2020).
Globally, there are many reports of the rapid spread of COVID-19 amongst residents of skilled 
nursing facilities following identification of an index case, with high associated rates of 
morbidity and mortality (Arons et al. 2020; Grabowski and Mor 2020; Graham et al. 2020).  In 
the USA, at least 153,000 residents and employees of nursing homes have contracted 
COVID-19, accounting for 35% of the country’s deaths (Werner et al. 2020).  With over 1.3 
million residents in nursing home care in the USA (CDC 2016), there is an urgent need for 
therapeutic strategies to prevent COVID-19 in these populations.
This study aims to evaluate the impact of LY3819253 alone and in combination with 
LY3832479 in preventing SARS-CoV-2 infection and COVID-19 in facility staff and residents 
in skilled nursing and assisted living facilities with a high risk of SARS-CoV-2 exposure.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
9
O bjecti ves a n d E n d p oi nt s
P art 1
T o facilitate ra pi d pr o p h yla xis a n d tr e at me nt of resi de nts a n d facilit y staff, parti ci pa nts will be 
e nr o lle d pri or t o assess me nt of baseli ne S A R S -C o V - 2 re verse tra nscri pti on – p ol y merase c hai n 
reactio n ( R T -P C R ) or ser ol o g y  res ults; t hus, m ult i ple a nal ysis p o p ulat i ons will e xist.  T his 
i ncl u des se parate pre ve nti on a n d treat me nt a nal ys is p o p ul at i ons ( defi ne d i n t he ta bles bel o w) a n d 
baseli ne ser ol o g y  p ositive partici pa nts.   E x pl orat or y  e nd p oi nts, i ncl u di n g t he treat me nt a nal ysis 
p o p ul at i on, are descri be d i n Sect i on  3 .
S af et y,  p har mac o ki net ics, a n d a nt i dr u g a nti b o dies will be c haracterize d i n t he o verall i nte nt t o 
treat p o p ulati on a n d i n t he a nal ysis p o p ulat i ons.
A d dit i onal p o p ulat i on s u bset a nal yses are d etaile d i n Secti o n 9 a n d/or i n t he stati stical a nal ysis 
pl a n.
Pre ve nti o n P o p ulati o n O bjecti ves a n d E n d p oi nts
Partici pa nts ne gati ve at baseli ne f or S A R S -C o V - 2 R T -P C R a n d s er ol o g y
C o m paris o n Gr o u ps: Place b o vs L Y 3 8 1 9 2 5 3 4 2 0 0 m g
O bjecti ves
E n d p oi nts
Pri mar y

C o m pare t he i nci de nce of C O VI D - 1 9 

C u m ulati ve i nci de nce of C O VI D -1 9 defi ne d 
as t he detecti o n of S A R S -C o V -2 b y R T -P C R 
A N D mil d or w orse disease se verit y a wit hi n 
2 1 da ys of detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n
Ke y Sec o n dar y

C o m pare t he i nci de nce of m o derate or w orse 
se verit y C O VI D- 1 9 

C u m ulati ve i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9; defi ne d as t he detecti o n 
of S A R S -C o V -2 b y R T -P C R A N D m o derate 
or w orse disease se verit y a wit hi n 2 1 da ys of 
detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n

C o m pare t he i nci de nce of S A R S -C o V - 2 
i nfecti o n 

C u m ulati ve i nci de nce of S A R S -C o V - 2; 
defi ne d as t he detecti o n of S A R S -C o V -2 b y 
R T -P C R 

Ti me fra me f or e n d p oi nt e val uati o n: 4 
wee ks fr o m ra n d o mizati o n

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 0
Ot her Sec o n dar y
[ti me fra me f or e n d p oi nt e val uati o n:  8 wee ks fr o m ra n d o mizati o n]

C o m pare t he i nci de nce of S A R S -C o V - 2 
i nfecti o n 

C u m ulati ve i nci de nce of S A R S -C o V - 2 
i nfecti o n defi ne d as t he detecti o n of S A R S-
C o V -2 b y R T -P C R

C o m pare t he fre q ue nc y of h os pitalizati o n or 
deat h d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o are 
h os pitalize d or ha ve die d d ue t o C O VI D - 1 9

C haracterize cli nical stat us f or partici pa nts.  

Pr o p orti o n ( perce nta ge) of partici pa nts w h o 
e x perie nce t hese e ve nts: 
o
C O VI D -1 9 relate d h os pitalizati o n 
( defi ne d as ≥2 4 h o urs of ac ute care),
o
C O VI D -1 9 relate d e mer ge nc y r o o m visit, 
or
o
deat h 

C o m pare t he m ortalit y d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o die d ue t o 
C O VI D -1 9 (acc or di n g t o t he i n vesti gat or) 
A b bre viati o ns : C O VI D -1 9 = c o r ona vir us disease – 2 0 1 9; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n 
reacti o n; S A R S-C o V -2 = se vere ac ute res pirat or y s y n dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 1
P art 2 Pre ve nti o n
P arti cipa nts will be teste d wi t h p oi nt of care S A R S-C o V -2 P O C test t o deter mi ne S A R S -C o V - 2 
stat us. Participa nts wi t h a ne gati ve P O C test will ra n d omize t o t he Pre ve nti o n C o h ort.  T h ose 
wi t h a p ositive test will e nr o ll t o t he Treat me nt C o h ort.
S af et y,  p har mac o ki netics, a n d a nti dr u g a nti b o dies will be c haracterize d i n t he o verall i nte nt t o 
treat p o p ulati on a n d i n t he a nal ysis p o p ulat i on s.
A d dit i onal p o p ulat i on s u bset a nal yses are detaile d i n Secti o n  9 a n d/ or in t he stati stical a nal ysis 
pl a n.
Part 2 Pre ve nti o n P o p ulati o n O bjecti ves a n d E n d p oi nts
Partici pa nt ne gati ve o n scree ni n g P oi nt of Care Test 
&
ne gati ve at baseli ne f or S A R S -C o V -2 R T -P C R a n d ser ol o g y
C o m paris o n Gr o u ps: 

Place b o vs L Y 3 8 1 9 2 5 3 7 0 0 m g

Place b o vs L Y 3 8 1 9 2 5 3 3 5 0 m g + L Y 3 8 3 2 4 7 9 7 0 0 m g
O bjecti ves
E n d p oi nts
Pri mar y

C o m pare t he i nci de nce of C O VI D - 1 9 

C u m ulati ve i nci de nce of C O VI D -1 9 defi ne d as 
t he detecti o n of S A R S-C o V -2 b y R T -P C R A N D 
mil d or w orse disease se verit y a wit hi n 2 1 da ys 
of detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n
Ke y Sec o n da r y

C o m pare t he i nci de nce of m o derate or w orse 
se verit y C O VI D- 1 9 

C u m ulati ve i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9; defi ne d as t he detecti o n of 
S A R S -C o V -2 b y R T -P C R A N D m o derate or 
w orse disease se verit y a wit hi n 2 1 da ys of 
detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n

C o m pare t he i nci de nce of S A R S -C o V - 2 
i nfecti o n 

C u m ulati ve i nci de nce of S A R S -C o V -2; defi ne d 
as t he detecti o n of S A R S -C o V -2 b y R T -P C R, 

Ti me fra me f or e n d p oi nt e val uati o n: 
4 wee ks fr o m ra n d o mizati o n

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 2
Ot her Sec o n dar y

C haracterize t he p har mac o ki net ics of 
L Y 3 8 1 9 2 5 3 a n d L Y 3 8 1 9 2 5 3 i n 
c o m bi nat i on wi t h L Y 3 8 3 2 4 7 9

Mea n c o nce ntrati o n of L Y 3 8 1 9 2 5 3 a n d 
L Y 3 8 1 9 2 5 3 i n t he prese nce of L Y 3 8 3 2 4 7 9 o n 
Da y 2 9

Mea n c o nce ntrati o n of L Y 3 8 3 2 4 7 9 i n t he 
prese nce of L Y 3 8 1 9 2 5 3 o n Da y 2 9
A b bre viati o ns: C O VI D -1 9 = c or o na vir us disease – 2 0 1 9; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n 
reacti o n; S A R S-C o V -2 = se vere ac ute res pirat or y s y n dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.
Part 3 o bject i ves are e x pl orat or y a n d t heref ore descri be d i n Secti on  3 .

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
13
Overall Design
Study J2X-MC-PYAD is a randomized, double-blind, placebo-controlled, prophylaxis study to 
evaluate the efficacy and safety of intravenous LY3819253, alone and in combination with 
LY3832479, in preventing SARS-CoV-2 infection and COVID-19, compared to placebo.  An 
independent Data Safety Monitory Board (DSMB) will actively monitor interim data to make 
recommendations about early study closure or changes to sample size.
Disclosure Statement: This is a three-part, 9-arm interventional study that is double-blinded.
Number of Participants:
For Part 1, a total of approximately 1700 participants (intent-to-treat [ITT] population) will be 
randomly assigned to study intervention such that approximately 1300 SARS-CoV-2 RT-PCR 
and serology negative participants are randomized in the study with the goal of achieving 
approximately 33 events (in each of the primary and key secondary endpoints) in the prevention 
population.
For Part 2, a total of approximately 2000 participants will be randomly assigned to study 
intervention based on rapid point of care (POC) testing such that approximately 1700
participants SARS-CoV-2 RT-PCR and serology negative participants are randomized in the 
Prevention Cohort with the goal of achieving approximately 56 events on each of the primary 
and key secondary endpoints.  
Part 3 will enroll at least 30 participants and up to approximately 500 participants randomized to 
study intervention.
The maximum sample size for this study is approximately 5000 participants in the ITT 
population.
Intervention Groups and Duration:
Participants will receive one intravenous infusion of study intervention.  
The maximum total duration of study participation for each participant of the prevention groups 
is 24 weeks.
The maximum total duration of study participation for each participant of the treatment group is 
12 weeks.
Part 1:
Eligible participants will be randomized to one of two arms: placebo or LY3819253 4200 mg.
Participants will continue to enroll to Part 1 until the needed events for the primary and key 
secondary endpoints are achieved and the minimum number of residents enroll.  
The evaluation period for Part 1 is 8 weeks, with follow-up to 24 weeks.
Part 2:
The Sponsor will decide when to trigger activation of Part 2.  Activation of Part 2 will be 
communicated to sites.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
14
All participants will be screened for SARS CoV-2 with a point of care (POC) test.  Participants 
who are negative will be assigned to the “Prevention Cohort”, while those who test positive will 
be assigned to the “Treatment Cohort”.

Prevention Cohort: Participants who are SARS-CoV-2 negative during screening on the 
POC test will be randomized to one of three arms: placebo, LY3819253 700 mg, or 
LY3819253-350 mg + LY3832479-700 mg.
If enrolling to a placebo-controlled trial is challenged by an effective medication 
becoming available for prevention of COVID-19 and SARS-CoV-2, then the placebo arm 
may be dropped.
Note:  It is possible that some participants have SARS-CoV-2 negative result on the 
screening point of care test, but could be positive on the baseline SARS-CoV-2 PCR test.  
The results from the baseline test will not be available until after the participant is 
randomized.  Once positive results are known from the baseline test, these participants 
will be unblinded and have the option to continue to be followed for safety according to 
the Prevention Cohort SoA.  Unblinded participants will not be included as part of the 
defined prevention population.  
The evaluation period for the Prevention Cohort is 8 weeks, with follow-up to Day 169.

Treatment Cohort: Participants who test SARS-CoV-2 positive during screening with the 
POC test will be randomized to one of two arms:  LY3819253 700 mg, or LY3819253
700 mg + LY3832479 1400 mg.  
The evaluation period for the Treatment Cohort is 4 weeks, with follow-up to Day 85.
Part 3
The Sponsor will decide when to trigger activation of Part 3.  Activation of Part 3 will be 
communicated to sites.  Part 3 may be activated prior to Part 2.
Eligible participants will be randomized to one of two arms:  LY3819253 700 mg or LY3819253 
700 mg + LY3832479 1400 mg.  The evaluation period for Part 3 is 4 weeks, with follow-up to 
Day 85.
Data Monitoring Committee: Yes.  Equivalent to Data Safety Monitoring Board for this study.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 5
1. 2.
Sc he m a
P art 1 : 
A b bre viati o ns:  P B O = place b o .
P art 2 :
A b bre viati o ns:  P B O = place b o.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 6
P A R T 3 :

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 7
1. 3.
Sc he d ule of Acti vities ( S o A)
Scree ni n g pr oce d ures ma y be c o n d ucte d o ver m ore t ha n 1 da y , as lo n g as all acti vities are c o mplete d wi t hi n t he all o we d i nter val 
t olera nce.  Scree ni n g a n d Da y 1 pr oce d ures ma y occ ur o n t he sa me da y.
P arti cipa nts w h o test p osit i ve f or S A R S-C o V -2 d uri n g t he E val uat i on P eri o d m a y ha ve t heir sc he d ule d visit(s) c o n d ucte d as a re m ot e 
healt h assess me nt .  Refer t o t he st u d y  d a y a n d visit t ype ta bl e i n Sect i on  4. 1. 2 f or a d dit i onal clarificat i o n.
Earl y Ter mi nat i on Visits are c o n d ucte d w he n t he partici pa nt is wit h dra w n fr o m t he st u d y pri or t o t he p ost -e val uat i on f oll ow- u p .
1. 3. 1.
P art 1 a n d Pre ve nti o n C o h ort of P a rt 2 
Pr oce d ures
Scree ni n g
E v al u ati o n Peri o d
E T V
P ost- E v al u ati o n F oll o w -U p
C o m me nts
St u d y Da y
Ma x 
7 -da y
wi n d o w
1
2 - 7
8
1 5
2 2
2 9
3 6
4 3
5 0
5 7
8 5
1 4 1
1 6 9
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
--
2
2
2
2
2
2
2
2
7
7
7
Ra n d o mizati o n
X
A d mi nister st u d y 
i nter ve nti on 
(I V i nf usi o n)
X
I nf or me d C o nse nt
X
I ncl usi o n a n d 
e xcl usi o n criteria 
re vie w
X
De m o gra p hics
X
I ncl u di n g a ge, ge n der, race, 
et h nicit y
Pree xisti n g 
c o n diti ons a n d 
me dical hist or y
X
O btai ne d fr o m i nter vie w or 
a vaila ble i nf or mati o n.
F or p artici pa nts wit h s y m pt o ms 
s u g gesti ve of C O VI D- 1 9, o btai n 
ti mi n g of o nset of s y m pt o ms

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 8
Pr oce d ures
Scree ni n g
E v al u ati o n Peri o d
E T V
P ost- E v al u ati o n F oll o w -U p
C o m me nts
St u d y Da y
Ma x 
7 -da y
wi n d o w
1
2 - 7
8
1 5
2 2
2 9
3 6
4 3
5 0
5 7
8 5
1 4 1
1 6 9
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
--
2
2
2
2
2
2
2
2
7
7
7
Pri o r treat me nts of 
s pecial i nterest 
X
Wit hi n t he last 2 wee ks: N S AI Ds, 
a nti virals, a nti bi otics, a nti -malarials, 
c ortic oster oi ds, i m m u n o m o d ulat ors ,
or ot her i n vesti gati o nal treat me nts .
At a n y ti me: S A R S -C o V -2 vacci ne
T o bacc o use
X
Ne ver/ f or mer/ c urre nt use
C o nc o mita nt 
me dicati o ns
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X
A d verse e ve nts 
( A Es)
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X
A n y e ve nts t hat occ ur after si g ni n g 
t he i nf or me d c o nse nt are c o nsi dere d 
A Es as defi ne d i n Secti o n  1 0 . 3, 
A p pe n di x 3.
P h y sical 
e xa mi nati o n
X
S y m pt o m -directe d 
p h y sical e xa m
X
X  
X  
X
As i n dicate d base d o n partici pa nt 
stat us a n d sta n dar d of care.  
Hei g ht
X
Wei g ht
X
Vital si g ns
X
Dail y
X  
X  
X
D oc u me ntati o n of h os pital -base d 
e xa m is acce pta ble.
I ncl u des: b o d y te m perat ure, p ulse 
rate, B P, S p O 2, res pirat or y rate, 
Fi O 2 if k n o w n, a n d met h o d of 
deli ver y, if a p plica ble. 
Rec or d w hile partici pa nt is at rest.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 9
Pr oce d ures
Scree ni n g
E v al u ati o n Peri o d
E T V
P ost- E v al u ati o n F oll o w -U p
C o m me nts
St u d y Da y
Ma x 
7 -da y
wi n d o w
1
2 - 7
8
1 5
2 2
2 9
3 6
4 3
5 0
5 7
8 5
1 4 1
1 6 9
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
--
2
2
2
2
2
2
2
2
7
7
7
H os pitalizati o n 
e ve nts
Dail y
X  
X
X
Rec or d if t he f oll o wi n g e ve nts 
occ ur:

E mer ge nc y r o o m visits

h os pitalize d

I CU a d mitta nce, 

E xte n de d care facilit y 
a d mitta nce, 

a n d disc har ge f or a n y of t he 
a b o ve
Cli nical stat us a n d 
c o nc o mita nt 
pr oce d ures of 
s pecial i nterest i n 
h os pitalize d 
partici pa nts
Dail y
X  
X
X
D oc u me ntati o n fr o m h os pital 
rec or ds is acce pta ble.
I ncl u des: 
c o nsci o us ness stat us ( A C V P U),
li mitati o n o n acti vities d ue t o 
C O VI D -1 9, a n d re q uire me nts f or

O n g oi n g h os pital me dical care

S u p ple me ntal o x y ge n

n o n -i n vasi ve ve ntilati o n or a 
hi g h fl o w o x y ge n de vice 

mec ha nical ve ntilati o n

e xtrac or p oreal me m bra ne 
o x y ge nati o n, or

a d diti o nal or ga n s u p p ort (e. g. 
press ors, re nal re place me nt)
Cli nical s y m pt o ms 
a n d i nter ve nti o ns of 
i nterest
Dail y
X  
X
See  Ta ble 1 f or cli nical s y m pt o ms 
a n d i nter ve nti o ns of i nterest.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
2 0
Pr oce d ures
Scree ni n g
E v al u ati o n Peri o d
E T V
P ost- E v al u ati o n F oll o w -U p
C o m me nts
St u d y Da y
Ma x 
7 -da y
wi n d o w
1
2 - 7
8
1 5
2 2
2 9
3 6
4 3
5 0
5 7
8 5
1 4 1
1 6 9
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
--
2
2
2
2
2
2
2
2
7
7
7
S y m pt o ms 
Q uesti o n naire
X
Dail y
X  
X
See Secti o n  8. 1. 2 .
S A R S -C o V -2 P O C
Test (Nasal S wa b )
X
A p plies t o partici pa nts i n Part 2 
o nl y.
Res ult m ust be deter mi ne d pri or t o 
c ollecti n g s wa bs f or P C R test.
S A R S -C o V - 2 
Ser ol o g y
X
X
X  
X  
X  
X  
X
Da y 1:  pre -d ose.
assesse d at a ce ntral la b orat or y
S A R S -C o V - 2 
nas o p har y n geal 
s wab (f or P C R test)
ta ke n fr om b ot h 
n ostrils
X
Da y 1:  pre -d ose.
assesse d at a ce ntral la b orat or y
S A R S -C o V - 2 nasal
s wab (f or P C R test)
ta ke n fr om b ot h 
n ostrils
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X
Da y 1:  pre -d ose.
assesse d at a ce ntral la b orat or y
N o sa m ples nee de d if partici pa nt is 
h os pitalize d. *

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
2 1
Pr oce d ures
Scree ni n g
E v al u ati o n Peri o d
E T V
P ost- E v al u ati o n F oll o w -U p
C o m me nts
St u d y Da y
Ma x 
7 -da y
wi n d o w
1
2 - 7
8
1 5
2 2
2 9
3 6
4 3
5 0
5 7
8 5
1 4 1
1 6 9
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
--
2
2
2
2
2
2
2
2
7
7
7
Ur i ne pre g na nc y
X  
X
X
X
O nl y f or W O C B P ( Secti o n  1 0. 4 ,
A p pe n di x 4) L ocal la b orat or y. 
Test perf or me d i n t he 2 4 h o urs pri or 
t o st u d y e ntr y will be acce pte d f or 
deter mi nati o n of eli gi bilit y.
N o sa m ples nee de d if partici pa nt is 
h os pitalize d. *
He mat ol o g y
X
X
X  
X  
X  
X
Da y 1:  pre -d ose.
Assa y e d b y Lill y-desi g nate d 
la b orat or y
N o sa m ples nee de d if partici pa nt is 
h os pitalize d. *
Cli nical C he mistr y
X
X
X  
X  
X  
X
Da y 1:  pre -d ose.
Assa y e d b y Lill y -desi g nate d 
la b orat or y
N o sa m ples nee de d if partici pa nt is 
h os pitalize d. *
L D H
X
X  
X
Da y 1:  pre -d ose.
Assa y e d b y Lill y-desi g nate d 
la b orat or y
N o sa m ples nee de d if partici pa nt is 
h os pitalize d. *

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
22
Procedures
Screening
Evaluation Period
ETV
Post-Evaluation Follow-Up
Comments
Study Day
Max 
7-day
window
1
2-7
8
15
22
29
36
43
50
57
85
141
169
Visit window 
(± number of days)
--
--
--
2
2
2
2
2
2
2
2
7
7
7

C-reactive 
protein; high-
sensitivity

Ferritin

D-dimer

Procalcitonin

Troponin
X
X
X
Day 1:  pre-dose.
Assayed by Lilly-designated 
laboratory
No samples needed if participant is 
hospitalized.*
PK sample
X
X
X
X
X
X
X
Day 1: pre-dose.
For participants in Part 2, Day 1 
collection is post-dose only (approx. 
30 minutes after end of infusion).
Assayed by Lilly-designated 
laboratory
No samples needed if participant is 
hospitalized.*
Immunogenicity 
(ADA) sample
X
X
X
X
X
X
X
Day 1:  pre-dose. 
Remaining days: Collect with time-
matched PK sample.
No samples needed if participant is 
hospitalized.*
Exploratory 
biomarker samples
X
X
X
X
X
X
Day 1: pre-dose
Assayed by Lilly-designated 
laboratory
No samples needed if participant is 
hospitalized.*
Pharmacogenetics
sample
X
Assayed by Lilly-designated 
laboratory

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
23
Abbreviations:  ACVPU = alert, confusion, voice, pain, unresponsive; ADA = antidrug antibody; AE = adverse event; BP = blood pressure; COVID-19 = coronavirus disease –
2019; FiO2 = fraction of inspired oxygen in the air; ETV = early termination visit; FiO2 = fraction of inspired oxygen; ICU = intensive care unit; IV = intravenous; LDH = 
lactate dehydrogenase; NSAID = nonsteroidal anti-inflammatory drug; PCR = polymerase chain reaction; PK = pharmacokinetic; POC = point of care; SpO2 = saturation of 
peripheral oxygen; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; WOCBP = women of child-bearing potential
*
Participants will continue to follow the Schedule of Activities upon discharge from hospital. No local lab result data will be collected in the eCRF while hospitalized.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
2 4
1. 3. 2.
P art 2 Tre at me nt C o h ort a n d P art 3 
Scree ni n g f or Part 2 is descri be d i n t he ta ble a b o ve ( Secti o n 1. 3. 1 ).  Scree ni n g is pr o vi de d bel o w f or refere nce.
Pr oce d ures
Scree ni n g
E v al u ati o n 
Peri o d
E T V
P ost -tre at me nt 
f oll o w-u p
C o m me nts
St u d y Da y
Ma x 7 da y
wi n d o w
1
8
2 9
8 5
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
1
2
7
Ra n d o mizati o n
X
A d mi nister st u d y 
i nter ve nti on 
(I V i nf usi o n)
X
I nf or me d C o nse nt
X
I ncl usi o n a n d 
e xcl usi o n criteria 
re vie w
X
N ote t hat eli gi bilit y criteria f or Part 2 a n d Part 3 are differe nt.
De m o gra p hics
X
I ncl u di n g a ge, ge n der, race, et h nicit y
Pree xisti n g 
c o n diti ons a n d 
me dical hist or y
X
O btai ne d fr o m i nter vie w or a vaila ble i n f or mati o n.
F or partici pa nts wit h s y m pt o ms s u g gesti ve of C O VI D -1 9, o btai n ti mi n g of 
o nset of s y m pt o ms
Pri o r treat me nts of 
s pecial i nterest 
X
Wit hi n t he last 2 wee ks: N S AI Ds, a nti virals, a nti bi otics, a nti -malarials, 
c ortic oster oi ds, i m m u n o m o d ulat ors , or ot her i n vesti gati o nal treat me nts .
At a n y ti me: S A R S -C o V -2 vacci ne
T o bacc o use
X
Ne ver/ f or mer/ c urre nt use
C o nc o mita nt 
me dicati o ns
X  
X  
X  
X  
X
A d verse e ve nts 
( A Es)
X  
X  
X  
X  
X  
X
A n y e ve nts t hat occ ur after si g ni n g t he i nf or me d c o nse nt are c o nsi dere d A Es 
as defi ne d i n Secti o n  1 0. 3 , A p pe n di x 3.
P h y sical 
e xa mi nati o n
X
S y m pt o m -directe d 
p h y sical e xa m
X
X  
X
As i n dicate d base d o n partici pa nt stat us a n d sta n dar d of care.  

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
25
Procedures
Screening
Evaluation 
Period
ETV
Post-treatment 
follow-up
Comments
Study Day
Max 7 day
window
1
8
29
85
Visit window 
(± number of days)
--
--
1
2
7
Height
X
Weight
X
Vital signs
X
X
X
X
X
X
Documentation of hospital-based exam is acceptable.
Includes: body temperature, pulse rate, BP, SpO2, respiratory rate, FiO2 if 
known, and method of delivery, if applicable. 
Record while participant is at rest.
Hospitalization 
events
X
X
X
X
X
Record if the following events occur:

Emergency room visits

hospitalized

ICU admittance, 

Extended care facility admittance, 

and discharge for any of the above
Clinical status and 
concomitant 
procedures of 
special interest in 
hospitalized 
participants
Daily
X
X
Documentation from hospital records is acceptable.
Includes: 
consciousness status (ACVPU),
limitation on activities due to COVID-19, and requirements for

Ongoing hospital medical care

Supplemental oxygen

non-invasive ventilation or a high flow oxygen device 

mechanical ventilation

extracorporeal membrane oxygenation, or

additional organ support (e.g. pressors, renal replacement)
SARS-CoV-2 
Serology
X
X
X
X
Day 1:  pre-dose.
assessed at a central laboratory
Documentation of 
positive SARS-
CoV-2 viral 
infection
X
Applies to participants in Part 3 only.
Sample for first positive test must be collected within 10 days prior to start of 
infusion. 
Local laboratory and/or Point-of-Care testing.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
2 6
Pr oce d ures
Scree ni n g
E v al u ati o n 
Peri o d
E T V
P ost -tre at me nt 
f oll o w-u p
C o m me nts
St u d y Da y
Ma x 7 da y
wi n d o w
1
8
2 9
8 5
Visit wi n d o w 
( ± n u m ber of d a ys)
--
--
1
2
7
S A R S -C o V - 2 
nas o p har y n geal
s wab ta ke n fr o m 
b ot h n ostrils 
X  
X  
X  
X  
X
Da y 1:  pre -d ose.
assesse d at a ce ntral la b orat or y
N o sa m ples nee de d if partici pa nt is h os pitalize d. *
Ur i ne pre g na nc y
X  
X
X  
X
O nl y f or W O C B P ( Secti o n  1 0. 4 , A p pe n di x 4) L ocal la b orat or y. 
Test perf or me d i n t he 2 4 h o urs pri or t o st u d y e ntr y will be acce pte d f or 
deter mi nati o n of eli gi bilit y.
N o sa m ples nee de d if partici pa nt is h os pitalize d. *
He mat ol o g y
X  
X  
X  
X
Da y 1:  pre -d ose.
Assa y e d b y Lill y-desi g nate d la b orat or y
N o sa m ples nee de d if partici pa nt is h os pitalize d. *
Cli nical C he mistr y
X  
X  
X  
X
Da y 1:  pre -d ose.
Assa y e d b y Lill y-desi g nate d la b orat or y
N o sa m ples nee de d if partici pa nt is h os pitalize d. *

C- reacti ve 
pr otei n; hi g h -
se nsiti vit y

Ferriti n

D- di mer

Pr ocalcit o ni n

Tr o p o ni n
X  
X  
X
Da y 1:  pre -d ose. 
Assa y e d b y Lill y-desi g nate d la b orat or y
N o sa m ples nee de d if partici pa nt is h os pitalize d. *
P K sa m ple
X  
X  
X  
X
Da y 1:  p ost -d ose o nl y ( a p pr o x. 3 0 mi n ute s after e n d of i nf usi o n ) 
Assa y e d b y Lill y-desi g nate d la b orat or y
N o sa m ples nee de d if partici pa nt is h os pitalize d. *
I m m u n o ge nicit y 
( A D A) sa m ple
X  
X  
X  
X
Da y 1:  pre -d ose. 
Re mai ni n g da ys: C ollect wit h ti me -matc he d P K sa m ple.
N o sa m ples nee de d if partici pa nt is h os pitalize d. *

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
27
Procedures
Screening
Evaluation 
Period
ETV
Post-treatment 
follow-up
Comments
Study Day
Max 7 day
window
1
8
29
85
Visit window 
(± number of days)
--
--
1
2
7
Exploratory 
biomarker samples
X
X
X
X
Day 1: pre-dose
Assayed by Lilly-designated laboratory
No samples needed if participant is hospitalized.*
Pharmacogenetics 
sample
X
Assayed by Lilly-designated laboratory
Abbreviations:  ACVPU = alert, confusion, voice, pain, unresponsive; ADA = antidrug antibody; AE = adverse event; BP = blood pressure; COVID-19 = coronavirus disease –
2019; FiO2 = fraction of inspired oxygen in the air; ETV = early termination visit; FiO2 = fraction of inspired oxygen; ICU = intensive care unit; IV = intravenous; NSAID = 
nonsteroidal anti-inflammatory drug; PK = pharmacokinetic; SpO2 = saturation of peripheral oxygen; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; 
WOCBP = women of child-bearing potential.
*
Participants will continue to follow the Schedule of Activities upon discharge from hospital.  No local lab result data will be collected in the eCRF while hospitalized.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
28
2.
Introduction
2.1.
Study Rationale
The efficient community spread of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-
CoV-2) has resulted in the current pandemic of Coronavirus Disease – 2019 (COVID-19), which 
in severe and critical cases results in progressive pulmonary infection, complicated by 
respiratory failure, with a high prevalence of acute respiratory distress syndrome.  Of all age 
groups, older adults have the greatest risk of severe COVID-19 and the associated complications 
(CDC 2020; Grabowski and Mor 2020).
Globally, there are many reports of the rapid spread of COVID-19 amongst residents of skilled 
nursing facilities following identification of an index case, with high associated rates of 
morbidity and mortality (Arons et al. 2020; Grabowski and Mor 2020; Graham et al. 2020).  In 
the USA, at least 153,000 residents and employees of nursing homes have contracted 
COVID-19, accounting for 35% of the country’s deaths (Werner et al. 2020).  With over 1.3 
million residents in nursing home care in the USA (CDC 2016), there is an urgent need for 
therapeutic strategies to prevent COVID-19 in these populations.
This study aims to evaluate the impact of LY3819253 and LY3819253 in combination with 
LY3832479 in preventing SARS-CoV-2 infection and COVID-19 in facility staff and residents 
in skilled nursing and assisted living facilities with a high risk of SARS-CoV-2 exposure.
2.2.
Background
The SARS-CoV-2 gains entry to cells through binding of the spike (S) protein to ACE2 receptors 
on cells (Hoffmann 2020).  LY3819253 and LY3832479 are neutralizing immunoglobulin G1 
(IgG1) monoclonal antibodies (mAb) to the spike protein of SARS-CoV-2.  They are designed to 
block viral attachment and entry into human cells, and to neutralize the virus.  The blocking of 
viral entry into respiratory cells and viral replication is expected to prevent and/or mitigate the 
severity of disease in people whom ongoing viral spread and replication is the primary driver of 
COVID-19 pathophysiology.  For those that become infected, the decrease in viral replication 
may also shorten a patient’s extent and duration of viral shedding and transmission, positively 
impacting public health.
Lilly is evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) 
of LY3819253 in participants hospitalized for COVID-19, in Study J2W-MC-PYAA (PYAA), a 
randomized, placebo-controlled, double-blind, single ascending dose, Phase 1, first in human 
study.  
Lilly is evaluating the safety, tolerability, PK, and immunogenicity of LY3832479 in healthy 
participants, in a randomized, placebo-controlled, single dose, Phase 1 study (Study J2Z-MC-
PGAA [PGAA]) under IND 150707. Concurrent with Study PGAA, LY3832479 is also under 
development in China in an ongoing Phase 1 clinical study in healthy participants, Study JS016-
001-I. Both studies have started prior to this amendment.
In addition, the impact of LY3819253, alone or in combination with LY3832479, on viral load 
and clinical outcomes in participants with early mild to moderate COVID-19 illness is being 

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
2 9
i n vesti gate d i n St u d y  J 2 W-M C -P Y A B ( P Y A B), a P hase 2 , ra n d o mize d, d o u ble-bli n d st u d y .
I nteri m a nal ysis fr om t his st u d y s u g gests treat me nt wit h L Y 3 8 1 9 2 5 3 ma y decrease t he ris k of 
h os pi talizati on i n pat ient s wit h mil d t o m o derate C O VI D -1 9 ( C he n et al. 2 0 2 0)
A d dit i onal i nf or mati o n a b o ut t hese st u dies ca n be f o u n d i n t he I n vesti gat or’s Br oc h ure (I B).
2. 3.
Be nefit/ Ris k Assess me nt
A nt ici pate d ris k is c o nsi dere d l o w a n d is base d o n t he k n o w n mec ha nis m of act i on f or h u ma n 
deri ve d ne utralizi n g a nt i b o dies i n ac ute viral disease states.  L Y 3 8 1 9 2 5 3 a n d L Y 3 8 3 2 4 7 9 c o nsist 
of  a hi g hl y s pecific m A bs directe d at f orei g n ( n o n -h u ma n) e pit o pe(s) a n d will be gi ve n t o 
parti ci pa nts at a hig h ri s k of S A R S-C o V - 2 e x p os ure i n a c o ntr olle d setti n g.  T he 
c o mple me ntari t y deter mi ni n g re gi o ns of t he m A bs were deri ve d fr o m B l y m p h oc y t es of 2 
i n di vi d uall y c o n valesce nt nat urall y S A R S -C o V - 2-i nfecte d patie nts a n d, t hus, ha ve u n der g o ne 
nat ural  p ositi ve a n d ne gati ve selecti o n press ures i n vi v o, u nli ke h u ma nize d a nti b o dies ge nerate d 
i n mice.  N o  cli nicall y rele va nt off-tar get bi n di n g has bee n o bser ve d i n tiss ue cr oss reacti vity 
st u dies of me m bra ne tar gets i n h u ma n tiss ues.  T heref ore, off -tar get bi n di n g a n d tiss ue cr oss-
reacti vity are c o nsi dere d u nli kel y.  
A t he oretical ris k is t hat t hese i nter ve nt i ons ma y ca use a nti b o d y -de pe n de nt e n ha nce me nt ( A D E) 
of  viral re plicati on.  T hi s is base d o n res p o nses o bser ve d t o s o me m on ocl o nal  a nti b o d y t hera pies 
use d i n ot her u nrelate d viral diseases.  U nli ke A D E ass ociate d wit h De n g ue a n d Zi ka vir us 
i nfecti ons, t his p he n o m e n o n has n ot bee n clearl y esta blis he d f or c or o navir us i nfecti o ns, s uc h as 
Se vere Ac ute Res pirat or y  S y n dr o me (S A R S ) a n d Mi d dle East Res pi r at or y S y n dr o me, a n d has 
n ot bee n re p orte d t o date wit h S A R S -C o V -2.  A d dit i onall y , li mite d e x perie nce wit h t he use of 
c o n valesce nt ser u m as a treat me nt f or patie nts wit h se vere C O VI D -1 9 di sease has n ot i n dicate d 
safety c o ncer ns ( S he n 2 0 2 0; D ua n 2 0 2 0).  
T he ri s k of cli nical A D E f or eit her i nter ve nti o n or i n c o m bi nati on is c o nsi dere d l o w d ue t o

t he str uct ural feat ures of L Y 3 8 3 2 4 7 9, w hic h is e n gi neere d t o s u p press its bi n di n g t o Fc 
rece pt ors a n d C 1 q m

t he a bse nce of A D E fr o m i n vitr o st u dies, a n d

t he a bse nce of A D E fr o m i n vi v o n o n h u ma n pri mate st u dies f or L Y 3 8 1 9 2 5 3 .
T o date, t here is n o e vi de nce of pr o d ucti ve e n ha nce me nt of A D E wi t h S A R S-C o V - 2.
A d dit i onal ma na gea ble ris ks ass ociate d wit h m ost t hera pe utic m o n ocl o nal a nt i b o dies are t he 
p ote nti al for i nf usi o n -relate d h yperse nsi tivi t y a n d c yt o ki ne release reacti ons.  T he si n gle i nf usi o n 
i n t his st u d y will be a d mi nistere d at a c o ntr olle d rate, t he st u d y partici pa nts will be mo ni t or e d 
clos el y , a n d a djust m e nts i n t he i nf usi o n rate will be ma de a n d/ or t he i nf usi o n st o p pe d, if 
i n dicate d.  A d diti o nal i nf or mati on re gar di n g i nf usi o n reacti o n ma na ge me nt o pti o ns is l ocate d i n 
Secti o n  6. 1. 1. 2 .  As of 3 1 Dece m ber 2 0 2 0 , a p pr o xi matel y 4 0 1 2 parti ci pa nts recei ve d bli n de d 
treat me nt of L Y 3 8 1 9 2 5 3 7 0 0 m g, 2 8 0 0 m g, or 7 0 0 0 m g, or place b o , of w hic h a p pr o xi matel y 
3 1 8 9 partici pa nts recei ve d L Y 3 8 1 9 2 5 3 . Seri o us i nf usi o n -relate d reacti o ns, i ncl u di n g e ve nts 
c o nsiste nt wit h a na p h yla xis, were re p o rte d i n t hese o n g oi n g st u dies wit h L Y 3 8 1 9 2 5 3 ( F D A E U A 
fact s heet 2 0 2 0).

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
30
Clinical worsening of COVID-19 after administration of LY3819253 has been reported from 
post-authorization treatment within 24 hours of infusion. Signs and symptoms may include fever, 
hypoxia or increased respiratory difficulty, arrythmia (e.g., atrial fibrillation, sinus tachycardia, 
and bradycardia), fatigue, and altered mental status. Some of these events required 
hospitalization. It is not known if these events were related to LY3819253 use or were due to 
progression of COVID-19.
Combination of LY3819253 and LY3832479
As of 04 November 2020, 542 participants in Study PYAB received blinded treatment of either 
placebo or the combination of 2800 mg LY3819253 and 2800 mg LY3832479. Three
participants reported single immediate non-serious events of pruritis (2 events) and dyspnea (1 
event).   
Data from Study PYAB interim analysis indicate treatment with LY3819253 or the combination 
of LY3819253 and LY3832479 may decrease the risk of hospitalization in patients with mild to 
moderate COVID-19 (Chen et al. 2020; Gottlieb et al. 2020) thus providing benefit to patients 
with COVID-19.
Given the totality of data on LY3819253 and LY3832479, the well-established safety profile of 
other therapeutic mAbs, and the lack of disease directed therapeutic options for patients with 
COVID-19 illness or to prevent the SARS-CoV-2 infection, the overall benefit/risk assessment 
of this study is considered favorable.
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of LY3819253 and LY3832479 may be found in each respective IB.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 1
3.
O bjecti ves a n d E n d p oi nts
P art 1
T o facilitate ra pi d pr o p h yla xis a n d treat me nt of resi de nts a n d facility staff , partici pa nts will be 
e nr o lle d pri or t o assess me nt of baseli ne S A R S -C o V -2 re verse tra nscri pt i on – p ol y merase c hai n 
reactio n ( R T -P C R) or ser ol o g y  res ults; t h us, mul ti ple a nal ysis p o p ulat i ons will e xist.  T his 
i ncl u des se parate pre ve nti on a n d treat me nt a nal ysis p o p ulat i ons ( defi ne d i n t he ta bles bel o w) a n d 
baseli ne ser ol o g y  p ositive partici pa nts.
S af et y,  p har mac o ki netics, a n d a nti dr u g a nti b o dies will be c haracterize d i n t he o verall  int e nt t o 
treat p o p ulati on a n d i n t he a nal ysis p o p ulat i ons.
A d dit i onal p o p ulat i on s u bset a nal yses are detaile d i n Secti o n  9 a n d/ or in t he st atistical a nal ysis 
pl a n.
Pre ve nti o n P o p ulati o n O bjecti ves a n d E n d p oi nts
Partici pa nts ne gati ve at baseli ne f or S A R S -C o V - 2 R T -P C R a n d s er ol o g y
C o m paris o n Gr o u ps: Place b o vs L Y 3 8 1 9 2 5 3 4 2 0 0 m g
O bjecti ves
E n d p oi nts
Pri mar y

C o m pare t he i nci de nce of C O VI D - 1 9

C u m ulati ve i nci de nce of C O VI D - 1 9 defi ne d 
as t he detecti o n of S A R S -C o V -2 b y R T -P C R
A N D mil d or w orse disease se verit y a wit hi n 
2 1 da ys of detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n
Ke y Sec o n dar y

C o m pare t he i nci de nce of m o d er ate or w orse 
se verit y C O VI D- 1 9 

C u m ulati ve i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9; defi ne d as t he detecti o n 
of S A R S -C o V -2 b y R T -P C R A N D m o derate 
or w orse disease se verit y a wit hi n 2 1 da ys of 
detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n

C o m pare t he i nci de nce of S A R S -C o V- 2 
i nfecti o n

C u m ulati ve i nci de nce of S A R S -C o V - 2; 
defi ne d as t he detecti o n of S A R S -C o V -2 b y 
R T -P C R 

Ti me fra me f or e n d p oi nt e val uati o n: 4
wee ks fr o m ra n d o mizati o n
Ot her Sec o n dar y
[ti me fra me f or e n d p oi nt e val uati o n:  8 wee ks fr o m ra n d o mizati o n]

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 2

C o m pare t he i nci de nce of S A R S -C o V - 2 
i nfecti o n 

C u m ulati ve i nci de nce of S A R S -C o V - 2 
i nfecti o n defi ne d as t he detecti o n of S A R S-
C o V -2 b y R T -P C R

C o m pare t he fre q ue nc y of h os pitalizati o n or 
de at h d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o are 
h os pitalize d or ha ve die d d ue t o C O VI D - 1 9

C haracterize cli nical stat us f or partici pa nts.  

Pr o p orti o n ( perce nta ge) of partici pa nts w h o 
e x perie nce t hese e ve nts: 
o
C O VI D -1 9 relate d h os pitalizati o n 
( define d as ≥2 4 h o urs of ac ute care),
o
C O VI D -1 9 relate d e mer ge nc y r o o m visit, 
or
o
deat h 

C o m pare t he m ortalit y d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o die d ue t o 
C O VI D -1 9 (acc or di n g t o t he i n vesti gat or) 
E x pl orat or y
[ti me fra me f or e n d p oi nt e val uati o n:  8 wee ks fr o m ra n d o mizati o n]

C o m pare ti me t o i m pr o ve me nt t o mil d 
se verit y s y m pt o ms i n partici pa nts w h o 
de vel o p m o derate or w orse se verit y a
C O VI D - 1 9

Ti me t o i m pr o ve me nt t o mil d se verit y a

C haracterize C O VI D -1 9 ill ness a n d se verit y 
acc or di n g t o NI AI D or di nal scale(s)

W orst sc ore o n NI AI D or di nal scale(s)

C haracterize S A R S -C o V -2 viral e n d p oi nts i n 
t h ose partici pa nts t hat bec o me R T -P C R 
p ositi ve

Pr o p orti o n of partici pa nts t hat ac hie ve S A R S -
C o V -2 cleara nce wit hi n 1, 2, or 3 wee ks of 
p ositi ve R T -P C R

Ti me t o S A R S -C o V -2 cleara nce

C haracterize e mer ge nce of viral resista nce t o 
L Y 3 8 1 9 2 5 3

C o m paris o n fr o m t he first p ositi ve sa m ple t o 
at least t he last p os iti ve sa m ple 

C o m pare t he d urati o n of h os pitalizati o n d ue t o 
C O VI D - 1 9

C u m ulati ve da ys of h os pitalizati o n i n t h ose 
w h o are h os pitalize d d ue t o C O VI D - 1 9
A b bre viati o ns: C O VI D -1 9 = c or o na vir us disease – 2 0 1 9; NI AI D = Nati o nal I nstit ute of Aller g y a n d I nfecti o us 
Diseases; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n reacti o n; S A R S -C o V -2 = se vere ac ute res pirat or y 
s yn dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 3
Treat me nt P o p ulati o n E x pl orat or y O bjecti ves a n d E n d p oi nts
Partici pa nts p ositi ve at baseli ne f or S A R S -C o V - 2 R T -P C R a n d ne gati ve at baseli ne f or ser ol o g y
C o m paris o n Gr o u ps: Place b o vs L Y 3 8 1 9 2 5 3 4 2 0 0 m g
[ti me fra me f or e n d p oi nt e val uati o n: 8 wee ks fr o m ra n d o mizati o n]
O bjecti ves
E n d p oi nts

C o m pare t he fre q ue nc y of h os pitalizati o n or 
deat h d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o are 
h os pitalize d or ha ve die d d ue t o C O VI D - 1 9

C o m pare t he i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9 i n partici pa nts wit h o ut 
m o derate or w orse se verit y a C O VI D -1 9 at 
baseli ne 

C u m ulati ve i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9; defi ne d as m o derate or 
w orse disease se verit y a wit hi n 2 1 da y s of 
baseli ne

C o m pare t he i nci de nce of C O VI D -1 9 i n 
partici pa nts w h o are as y m pt o matic a baseli ne

C u m ulati ve i nci de nce of C O VI D -1 9; defi ne d 
as mil d or w orse disease se verit ya wit hi n 2 1 
da ys of baseli ne

C o m pare ti me t o i m pr o ve me nt t o mil d se verit y 
s y m pt o ms a i n partici pa nts w h o ha ve at 
baseli ne, or de vel o p, m o derate or w orse 
C O VI D - 1 9 

Ti me t o i m pr o ve me nt t o mil d se verit y a

C haracterize cli nical stat us f or partici pa nts.  

Pr o p orti o n ( perce nta ge) of partici pa nts w h o 
e x perie nce t hese e ve nts: 
o
C O VI D -1 9 relate d h os pitalizati o n 
( defi ne d as ≥2 4 h o urs of ac ute care),
o
C O VI D -1 9 relate d e mer ge nc y r o o m 
visit, or
o
deat h 

C haracterize C O VI D -1 9 ill ness a n d se verit y 
acc or di n g t o NI AI D or di nal scale(s)

W orst sc ore o n a NI AI D or di nal scale(s) 

C o m pare t he m ortalit y d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o die d ue t o 
C O VI D - 1 9

C haracterize S A R S -C o V -2 viral e n d p oi nts 

Pr o p orti o n of partici pa nts t hat ac hie ve 
S A R S -C o V -2 cleara nce wit hi n 1, 2, or 3 
wee ks of baseli ne

Ti me t o S A R S -C o V -2 cleara nce

C haracterize e mer ge nce of viral resista nce t o 
L Y 3 8 1 9 2 5 3

C o m paris o n fr o m baseli ne t o at least t he last 
p ositi ve sa m ple

C o m pare t he d urati o n of h os pitalizati o n d ue t o 
C O VI D - 1 9 

C u m ulati ve da ys of h os pitalizati o n i n t h ose 
w h o are h os pitalize d d ue t o C O VI D - 1 9
A b bre viati o ns: C O VI D -1 9 = c or o na vir us disease – 2 0 1 9; NI AI D = Nati o nal I nstit ute of Aller g y a n d I nfecti o us 
Diseases; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n reacti o n; S A R S -C o V -2 = se vere ac ute res pirat or y 
s yn dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 4
P art 2 Pre ve nti o n
P arti cipa nts will be teste d wi t h p oi nt of care S A R S-C o V -2 P O C test t o deter mi ne S A R S-C o V - 2 
stat us. Participa nts wi t h a ne gati ve PO C test will ra n d omize t o t he Pre ve nti o n C o h ort.  T h ose 
wi t h a p ositive test will e nr o ll t o t he Treat me nt C o h ort.
S af et y,  p har mac o ki netics, a n d a nt i dr u g a nti b o dies will be c haracterize d i n t he o verall i nte nt t o 
treat p o p ulati on a n d i n t he a nal ysis p o p ulat i on s.
A d dit i onal p o p ulat i on s u bset a nal yses are detaile d i n Secti o n  9 a n d/ or in t he stati stical a nal ysis 
pl a n.
Part 2 Pre ve nti o n P o p ulati o n O bjecti ves a n d E n d p oi nts
Partici pa nt n e gati ve o n scr ee ni n g P oi nt of Care Test 
&
ne gati ve at baseli ne f or S A R S -C o V -2 R T -P C R a n d ser ol o g y
C o m paris o n Gr o u ps: 

Place b o vs L Y 3 8 1 9 2 5 3 7 0 0 m g

Place b o vs L Y 3 8 1 9 2 5 3 3 5 0 m g + L Y 3 8 3 2 4 7 9 7 0 0 m g
O bjecti ves
E n d p oi nts
Pri mar y

C o m pare t he i nci de nce of C O VI D - 1 9 

C u m ulati ve i nci de nce of C O VI D - 1 9 defi ne d as 
t he detecti o n of S A R S-C o V -2 b y R T -P C R A N D 
mil d or w orse disease se verit y a wit hi n 2 1 da ys 
of detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n
Ke y S e c o n dar y

C o m pare t he i nci de nce of m o derate or w orse 
se verit y C O VI D- 1 9 

C u m ulati ve i nci de nce of m o derate or w orse 
se verit y C O VI D-1 9; defi ne d as t he detecti o n of 
S A R S -C o V -2 b y R T -P C R A N D m o derate or 
w orse disease se verit y a wit hi n 2 1 da ys of 
detecti o n

Ti me fra me f or e n d p oi nt e val uati o n: 8 
wee ks fr o m ra n d o mizati o n

C o m pare t he i nci de nce of S A R S -C o V- 2 
i nfecti o n 

C u m ulati ve i nci de nce of S A R S -C o V - 2; defi ne d 
as t he detecti o n of S A R S -C o V -2 b y R T -P C R 

Ti me fra me f or e n d p oi nt e val uati o n: 4   
wee ks fr o m ra n d o mizati o n

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 5
Ot her Sec o n dar y

C haracterize t he p har mac o ki netics of 
L Y 3 8 1 9 2 5 3 a n d L Y 3 8 1 9 2 5 3 i n c o m bi nati o n 
wit h L Y 3 8 3 2 4 7 9

Mea n c o nce ntrati o n of L Y 3 8 1 9 2 5 3 a n d 
L Y 3 8 1 9 2 5 3 i n t he prese nce of L Y 3 8 3 2 4 7 9 o n 
Da y 2 9

Mea n c o nce ntrati o n of L Y 3 8 3 2 4 7 9 i n t he 
prese nce of L Y 3 8 1 9 2 5 3 o n Da y 2 9
A b bre viati o ns: C O VI D -1 9 = c or o na vir us disease – 2 0 1 9; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n 
reacti o n; S A R S-C o V -2 = se vere ac ute res pirat or y s y n dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.
P art 2 a n d P art 3 Tre at me nt E x pl or at or y 
F or P art 3, res ults fr o m e xter nal, n o n-st u d y S A R S -C o V - 2 tests will be use d t o deter mi ne 
eli gi bilit y.
S af et y,  p har mac o ki netics, a n d a nt i dr u g a nti b o dies will be c haracterize d i n t he o verall i nte nt t o 
treat p o p ulati on a n d i n t he a nal ysis p o p ulat i ons.
Treat me nt P o p ulati o n E x pl orat or y O bjecti ves a n d E n d p oi nts
Partici pa nts p ositi ve o n scree ni n g P oi nt of Care Test ( Part 2)
&
p ositi ve at baseli ne f or S A R S -C o V - 2 R T -P C R a n d ne gati ve at baseli ne f or ser ol o g y
[ti me fra me f or e n d p oi nt e val uati o n:  4 wee ks fr o m ra n d o mizati o n]
O bjecti ves
E n d p oi nts

E val uate t he fre q ue nc y of h os pitalizati o n or 
deat h d ue t o C O VI D - 1 9 

Pr o p orti o n of partici pa nts w h o are 
h os pitalize d or ha ve die d d ue t o C O VI D - 1 9

C haracterize cli nical stat us f or partici pa nts.  

Pr o p orti o n ( perce nta ge) of partici pa nts w h o 
e x perie nce t hese e ve nts: 
o
C O VI D -1 9 relate d h os pitalizati o n 
( defi ne d as ≥2 4 h o urs of ac ute care),
o
C O VI D -1 9 relate d e mer ge nc y r o o m 
vis it, or
o
deat h 

C haracterize C O VI D -1 9 ill ness a n d se verit y 
acc or di n g t o NI AI D or di nal scale(s)

W orst sc ore o n a NI AI D or di nal scale(s) 

E val uate t he m ortalit y d ue t o C O VI D- 1 9 

Pr o p orti o n of partici pa nts w h o die d d ue t o 
C O VI D - 1 9

C haracterize S A R S -C o V -2 vir al e n d p oi nts 

Pr o p orti o n of partici pa nts t hat ac hie ve 
S A R S -C o V -2 cleara nce wit hi n 8 or 2 9 da ys 
of baseli ne

Ti me t o S A R S -C o V -2 cleara nce

C haracterize e mer ge nce of viral resista nce t o 
L Y 3 8 1 9 2 5 3 or L Y 3 8 3 2 4 7 9

C o m paris o n fr o m baseli ne t o at least t he last 
p ositi ve sa m ple

E val uate t he d urati o n of h os pitalizati o n d ue t o 
C O VI D - 1 9 

C u m ulati ve da ys of h os pitalizati o n i n t h ose 
w h o are h os pitalize d d ue t o C O VI D - 1 9

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 6
A b bre viati o ns: C O VI D -1 9 = c or o na vir us disease – 2 0 1 9; NI AI D = Nati o nal I nstit ute of Aller g y a n d I nfecti o us 
Diseases; R T -P C R = re verse tra nscri pti o n – p ol y merase c hai n reacti o n; S A R S -C o V -2 = se vere ac ute res pirat or y 
s yn dr o me c or o na vir us 2.
a
As defi ne d i n  Ta ble 1.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 7
4.
St u d y Desi g n
4. 1.
O ver all Desi g n
St u d y  J 2 X-M C -P Y A D is a r a n d o mize d, d o u ble -bli n d, place b o -c o ntr olle d , pr o p h yla xis st u d y t o 
e val uate t he efficac y a n d safet y of  i ntra ve n o us L Y 3 8 1 9 2 5 3 , alo ne a n d i n c o m bi nat i on wi t h 
L Y 3 8 3 2 4 7 9, i n pre ve nti n g S A R S -C o V -2 a n d C O VI D -1 9, c o mpare d t o place b o .  S kille d n ursi n g 
a n d assiste d li vi n g facilit ies will ser ve as t he setti n g t o fi n d part ici pa nts wi t h a hi g h ris k of 
S A R S -C o V -2 e x p os ure. T he Pri nci pal I n vest i gat or a n d site staff ma y be u naffiliate d wit h t he 
facility.
Resi de nts a n d facilit y staff ma y be i ncl u de d i n t his st u d y beca use i nfecte d facilit y staff, w h o ma y 
be as y m pt o mat ic, ma y be i m p orta nt i n t he s prea d of S A R S-C o V -2 wi t hi n lo n g ter m  care 
facilities (Gra ha m et al. 2 0 2 0 ).  T heref ore, pr o vi di n g pr o p h ylact ic treat me nt t o b ot h resi de nts a n d 
facility staff ma y be hi g hl y be neficial i n pre ve nti n g or li miti n g C O VI D-1 9 o ut brea ks .
A n i n de pe n de nt Data Safet y M o ni t ori n g B oar d C o m mittee ( D S M B ) will acti vel y m onit or 
i nteri m data t o ma ke rec o m me n dat i ons a b o ut earl y st u d y  clos ure or c ha n ges t o sa m ple size (see 
Secti o n 1 0. 1. 5 , A p pe n di x 1, f or more i nf or m at i on).
4. 1. 1.
Scree ni n g Peri o d
I ntereste d partici pa nts or t heir le gal a ut h orize d re prese ntati ve will si g n t he a p pr o priate i nf or me d 
c o nse nt d oc u me nt(s) pri or t o c o m plet i on of  a n y pr oce d ures.
T he i n vest i gat or or q ualifie d desi g nee will re vie w s y m pt o ms, ris k fact ors, a n d ot her n o n -i n vasi ve 
i ncl usi on a n d e xcl usi o n cri t eria prior t o a n y  in vasi ve pr oce d ures.  If t he partici pa nt is eli gi ble 
after t his re vie w, t he n site staff will p erf or m  t he i n vasi ve pr oce d ures t o c o nfir m eli gi bility.
Part 1 :
T he scree ni n g peri o d f or eac h site o pe ns w he n a c o nfir me d S A R S- C o V - 2 i n de x case at t he 
facility is re p orte d t o st u d y staff. Scree ni n g, ra n d o mizat i on a n d i n vesti gati o nal pr o d uct (I P)
a d mi nistrati o n m ust be c o m plete d wit hi n 7 da ys fr o m re p orti n g of t he i n de x case.
Part 2 :
Pri or t o ra n d o mizat i on i n Part 2, partici pa nts will recei ve a p oi nt of care ( P O C) test f or S A R S -
C o V -2 i nfect i on.  P artici pa nts will be all ocate d t o eit her Pre ve nt i on or Treat me nt C o h orts base d 
o n t he res ult.  Scree ni n g a n d Da y 1 ma y occ ur o n t he sa me d a y .
Part 3
T he scree ni n g peri o d f or eac h parti ci pa nt starts at t he si g ni n g of t he I C F . Scree ni n g,
ra n d omizat i on , a n d I P a d mi nistrati o n m ust be c o m plete d wit hi n 7 da ys fr o m si g ni n g t he I C F. 
4. 1. 2.
E v al u ati o n Peri o d
T he e valu ati o n p eri o d be gi ns w he n t he parti ci pa nt c o mpletes scree ni n g a n d is e nr olle d i n t he 
st u d y.  Assess me nts a n d pr oce d ures will be c o n d ucte d as descri be d i n t he S o A  ( Sectio n 1. 3 ).
P arti cipa nts i n Part 1 will be ra n d o mize d t o place b o or L Y 3 8 1 9 2 5 3 .  The S p o ns or will deci de 
w he n t o tri g ger acti vat i on of Part 2. Acti vat i on of Part 2 will be c o m m u nicate d t o sites.  

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
3 8
P arti cip a nts i n Part 2 will be assi g ne d t o a c o h ort as f oll o ws:

Pre ve nt i on C o h ort: Partici pa nts w h o are S A R S -C o V - 2 ne gati ve d uri n g scree ni n g o n t he 
P O C test will be ra n d omize d t o o ne of t hree ar ms:  place b o, L Y 3 8 1 9 2 5 3 7 0 0 m g, or 
L Y 3 8 1 9 2 5 3 3 5 0 m g + L Y 3 8 3 2 4 7 9 7 0 0 m g.   
If e nr olli n g t o a place b o-c o ntr olle d trial is c halle n ge d b y a n effecti ve me dicati o n 
bec o mi n g a vaila ble f or pre ve nt i on of C O VI D -1 9 a n d S A R S -C o V -2, t he n t he place b o ar m 
ma y be dr o p pe d.
N ote:  It is p ossi ble t hat s o me partici pa nts ha ve S A R S -C o V -2 ne gat i ve res ult o n t he 
scree ni n g p oi nt of care test, b ut c o ul d be p ositi ve o n t he baseli ne S A R S-C o V -2 P C R test.  
T he res ults fr o m t he baseli ne test wil l n ot be a vaila ble u ntil after t he partici pa nt is 
ra n d omize d.  O nce p osit i ve res ults are k n o w n fr o m t he baseli ne test, t hese partici pa nts 
will be u n bli n de d a n d ha ve t he o pti o n t o c o nti n ue t o be f o ll owe d f or safety acc or di n g t o 
t he Pre ve nt i on C o h ort S o A.  U n bli n de d part ici pa nts will n ot be i ncl u de d as part of t he 
defi ne d pre ve nt i on p o p ul at i on
T he e val uati o n peri o d f or t he Pre ve nt i on C o h ort is 8 wee ks, wi t h fol l ow- u p t o Da y  1 6 9.

Treat me nt C o h ort: Partici pa nts w h o test S A R S -C o V - 2 p osi ti ve d uri n g scree ni n g wit h t he 
P O C test will be ra n d o mize d t o o ne of t w o ar ms:  L Y 3 8 1 9 2 5 3 7 0 0 m g, or L Y 3 8 1 9 2 5 3
7 0 0 m g + L Y 3 8 3 2 4 7 9 1 4 0 0 m g .  
T he e val uati o n peri o d f or t he Treat me nt C o h ort is 4 wee ks, wit h f o ll ow- u p t o Da y  8 5.
P arti cipa nts i n Part 3 wil l be ra n d o mize d t o L Y 3 8 1 9 2 5 3 7 0 0 m g or L Y 3 8 1 9 2 5 3 7 0 0 m g a n d 
L Y 3 8 3 2 4 7 9 1 4 0 0 m g . T he e val uat i on peri o d f or P art 3 is 4 wee ks, wi t h fol l ow- u p t o D a y 8 5.
T he S p o ns or will deci de w he n t o tri g ger acti vat i on of Part 3.   Acti vat i on of Part 3 will be 
c o m m u nicate d t o sites.  Part 3 ma y be acti vate d pri or t o Part 2.   
Part 2 a n d Part 3 c o ul d be act i vate d c o nc urre ntl y.  H o we ver, Part 3 will n ot e nr oll co nc urre nt l y 
wi t h Part 2 at t he sa me facility.   
P arti cipa nts will recei ve o ne i ntra ve n o us i nf usi on of st u d y int er ve nt i on .  
T he m a xi m u m t ot al d uratio n of  st u d y partici pati on f or eac h partici pa nt of t he pre ve nt i on gr o u ps 
is 2 4 wee ks.  See t he S O A f or pre ve nt i on gr o u ps i n Secti o n  1. 3. 1 .
T he m a xi m u m t ot al d uratio n of  st u d y partici pati on f or eac h partici pa nt of t he treat me nt gr o u p is 
1 2 wee ks.   See t he S O A f or t he treat me nt gr o u p i n Secti o n  1. 3. 2 .
T his ta ble descri bes t he visit t y pes f or t he pre ve nti o n p o p ulati o n f or t his st u d y.  
St u d y D a y
Acti vit y
Visit T y pe 
0, 1
F oll o w S o A
O nsite 
8, 1 5, 2 2, 2 9, 3 6, 4 3, 5 0, 5 7
F oll o w S o A
Vital si g ns *
O nsite or H o me ( Virt ual 
[rec or d c ollecti o n] if 
h os pitalize d)

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
39
Daily 2 - 57
Vital signs and symptoms 
questionnaire daily*
Vital signs, clinical status, and 
concomitant procedures for 
hospitalized participants. 
Onsite or Home (Virtual 
[record collection] if 
hospitalized)
ETV and follow-up (85, 141, 169)
Follow SoA
Onsite or Home 
*Collected via direct data capture for onsite or home visits only.
This table describes the visit types for the treatment population for this study.
Study Day
Activity
Visit Type 
0, 1
Follow SoA
Onsite 
8, 29
Follow SoA
Vital signs*
Onsite or Home (Virtual 
[record collection] if 
hospitalized)
Daily 2-29
Vital signs, clinical status, and 
concomitant procedures for 
hospitalized participants. 
Virtual (record collection) if 
hospitalized
ETV and follow-up (85)
Follow SoA
Onsite or Home 
*Collected via direct data capture for onsite or home visits only.
Hospitalization
If a participant is hospitalized, efforts will be made to retrieve hospital records and report 
procedures and assessments according to the SoA, as feasible.
Definitions for COVID-19 Severity
This table gives the definitions for COVID-19 severity of illness for those participants who are 
SARS-CoV-2 positive as determined by standard RT-PCR assay or equivalent test.
Table 1
Definitions for COVID-19 Severity
Severity
Description 
Mild
Mild symptoms that could include: 
•
fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without 
shortness of breath or dyspnea 
AND 
No clinical signs indicative of Moderate, Severe, or Critical Severity
Moderate
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or 
shortness of breath with exertion
AND 
Clinical signs suggestive of moderate illness with COVID-19, such as:

respiratory rate ≥ 20 breaths per minute, 

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
40

heart rate ≥ 90 beats per minute 

O2 utilization increase of ≥ 1L/min (for participants receiving O2 at baseline)*

IV fluid initiation*
AND 
no clinical signs indicative of Severe or Critical Illness Severity
Severe
Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of 
moderate illness or shortness of breath at rest, or respiratory distress
AND
Clinical signs indicative of severe systemic illness with COVID-19, such as

respiratory rate ≥ 30 breaths per minute, 

heart rate ≥ 125 beats per minute, 

SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300
AND
No clinical signs indicative of Critical Illness Severity
Critical
Evidence of critical illness, defined by at least one of the following:

Respiratory failure defined based on resource utilization requiring at least one of the following:

endotracheal intubation and mechanical ventilation, 

oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via 
reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen 
≥0.5), 

noninvasive positive pressure ventilation, 

extracorporeal membrane oxygenation (ECMO), or

clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding 
therapies, but preceding therapies not able to be administered in setting of resource 
limitation)

Shock 

Multi-organ dysfunction/failure
Death
  
Abbreviations:  COVID-19 = coronavirus disease – 2019; FiO2 = fraction of inspired oxygen in the air; IV = intravenous; 
PaO2 = partial pressure of oxygen; SpO2 = saturation of peripheral oxygen.
Adapted from FDA 2020.
*Addition to FDA Guidance applies only to residents at skilled nursing and assisted living facilities.
4.1.3.
Follow-up Period
Part 1 and Prevention Cohort of Part 2 
Post-evaluation follow-up assessments will be conducted at Days 85, 141, and 169 according to 
the SoA.  Strategies to manage infection risks and reduce the burden of return visits may be used 
by sites, such as remote visits.
Part 2 Treatment Cohort and Part 3
A post-evaluation follow-up assessment will be conducted at Day 85 according to the SoA.  
Strategies to manage infection risks and reduce the burden of return visits may be used by sites, 
such as remote visits.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
4 1
4. 2.
Scie ntific R ati o n ale f or St u d y Desi g n
T his st u d y  is desi g ne d t o e val uate t he efficac y of a si n gle d ose of L Y 3 8 1 9 2 5 3, alo ne a n d i n 
c o m bi nat i on wi th L Y 3 8 3 2 4 7 9, c o mpare d t o pl ace b o i n pre ve nt i n g a n d treati n g S A R S -C o V - 2 
i nfecti on a n d C O VI D -1 9 i n resi de nts a n d facilit y staff at skille d n ursi n g a n d assiste d li vi n g 
facilities.
T he ra n d o mize d, d o u ble -bli n d , pl ace b o -c o ntr olle d desi g n will all o w a n o bject i ve assess me nt of 
t he efficac y a n d safety of  L Y 3 8 1 9 2 5 3, alo ne a n d i n c o m bi nati o n wi t h L Y 3 8 3 2 4 7 9, i n pre ve nti n g
S A R S -C o V - 2 i nfecti on a n d C O VI D - 1 9. A place b o -c o ntr olle d desi g n is a p pr o priate beca use
t here are c urre ntl y n o t hera pe utic a ge nts wit h pr o ve n be nefit f or pre ve nti on.   T he i nci de nce of  
C O VI D - 1 9 re prese nts a cli nicall y mea ni n gf ul e n d p oi nt f or a pre ve nt i on st u d y.
Resi de nts a n d facilit y staff are i ncl u de d i n t his st u d y as i nfecte d facility staff me m bers ma y be 
i m p orta nt i n t he s prea d of S A R S-C o V -2 wi t hi n lo n g t er m  care facilities (Gra ha m  et al. 2 0 2 0).  
T heref ore, pr o vi di n g pr o p h ylact ic treat me nt t o b ot h resi de nts a n d facility staff ma y be hi g hl y 
be neficial i n pre ve nt i n g or li miti n g C O VI D-1 9 o ut br ea ks.
St u di es ha ve s h o w n t hat f o ll owi n g t he i de ntificat i on of a n i n de x case, i nfect i on ca n s prea d 
r a pidl y  a mo n g resi de nts a n d facilit y staff i n s kille d n ursi n g facilities (Ar o ns et al . 2 0 2 0; Gra ha m 
et al. 2 0 2 0). T heref ore, ra n d o mizat i on a n d treat me nt of p artici pa nts wit hi n 7 da ys of 
i de ntificati on of t he first c o nfir me d p osit i ve case of S A R S-C o V -2 at a gi ve n facility is a 
re q uire me nt f or st u d y p artici p atio n at t hat facility.
I n Part 1, to f acilitate ra pi d pr o p h yla xis a n d treat me nt of resi de nts a n d facilit y staff, partici pa nts 
will be e nr o lle d pri or t o assess me nt of baseli ne S A R S-C o V -2 R T -P C R or ser ol o g y res ults, t h us 
m ult i ple a nal ysis p o p ulati ons will e xist.  T his i ncl u des se parate pre ve nt i on a n d treat me nt 
a nal ysis p o p ulati o ns a n d baseli ne ser ol o g y p ositive partici pa nts.  H o we ver, t he pri mar y  a nal ysis 
p o p ul at i on f or e val uati o n of efficac y i n pre ve nti n g S A R S-C o V -2 a n d C O VI D -1 9 will be 
restricte d t o partici pa nts w h o are S A R S -C o V -2 ne gati ve b y R T -P C R a n d ser ol o g y  ne gati ve at 
baseli ne. E x pl orat or y  a nal yses will be c o n d ucte d t o e val uate efficac y o f L Y 3 8 1 9 2 5 3 f or 
treat me nt i n partici pa nts w h o are S A R S -C o V -2 p osit i ve b y R T -P C R a n d ser o l og y  ne gati ve at 
baseli ne.
M o n ocl o nal  a nti b o dies ma y pr o vi de be nefit f or t he treat me nt of mil d t o m o derate C O VI D- 1 9
(F D A E U A fact s heet 2 0 2 0). T heref ore, pri or t o ra n d o mizat i on i n Part 2, partici pa nts will 
recei ve a P O C test f or S A R S-C o V -2 i nfect i on. Parti ci pa nts will be assi g ne d t o eit her Pre ve nti o n 
or Treat m e nt C o h orts base d o n t he res ult of t his P O C test. Des pite usi n g a S A R S -C o V -2 P O C 
test d urin g scree ni n g t o assi g n partici pa nts t o eit her t he Pre ve nti o n or Treat me nt c o h orts, 
baseli ne S A R S -C o V -2 R T -P C R a n d ser ol o g y  test res ults will be use d t o deter mi ne t he st u d y 
a nal ysis p o p ulati o ns. Refer t o Secti o n  9. 3 , P o p ulatio n s for A nal yses , f or furt her i nf or m at i on o n 
st u d y a nal ysis p o p ulat i ons a n d tre at me nt ar ms.
Part 3 of t he st u d y  is a t w o-ar m, o ut patie nt, o pe n-la bel, e x pl orat or y c o h ort e val uati n g t he 
efficac y a nd safet y  of L Y 3 8 1 9 2 5 3 a n d L Y 3 8 1 9 2 5 3 i n c o m bi nati on wi t h L Y 3 8 3 2 4 7 9 i n 
parti ci pa nts p ositive f or S A R S-C o V -2 wi t h or wit h o ut s y m pt o ms i n staff a n d resi de nts w h o are 
at hi g her ris k f or m ore se vere di sease a n d h os pitalizati o n i n s kille d n ursi n g a n d assiste d li vi n g 
facilities. F or Part 3 o nl y, partici pa nts w h o were i n i n de pe nde nt li vi n g sit uat i ons at t he facilities
c o uld be e nr o lle d t o t he st u d y.   

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SARS-CoV-2 vaccines are now available to the public. Those who received a vaccine are now 
allowed in the study to assess the safety of LY3819253 and LY3832479 after a person received a 
SARS-CoV-2 vaccine.
4.3.
Justification for Dose
Part 1
The 4200 mg single dose LY3819253 is selected for this study based on preliminary safety, 
tolerability, PK data from the first-in-human Study PYAA, and preclinical PK/PD modeling.  
Based on an estimated human half-life of approximately 19 days, a single dose of 4200 mg may 
be necessary to have a sustained lung concentration above the in vitro IC90 of viral cell-entry 
neutralization in 100% of participants for 4 weeks and in 90% of participants for a minimum of 
8 weeks.
Part 2 and Part 3
LY3819253
LY3819253 700 mg was estimated as the maximum therapeutic dose based on PK/PD viral
dynamics modeling and observed data from Study PYAB and has a sustained concentration 
above the in vitro IC90 of viral cell-entry neutralization in the lung tissue (95th percentile of the 
estimates used) for at least 28 days in 90% of the participant population. The lower dose of 350 
mg was selected to evaluate the lower limit of the confidence interval for clinical IC90, based on 
emerging data from ongoing study.  At dose levels greater than 700 mg, LY3819253 provides 
exposure coverage in at least 90% of participant population for approximately 8 weeks.
LY3832479
The LY3832479 1400 mg dose was selected as the maximum therapeutic dose based on PK/PD 
viral dynamics modeling, relative IC90 potency to LY3819253, and has a sustained concentration 
above the in vitro IC90 of viral cell-entry neutralization in the lung tissue for at least 28 days in 
90% of the participant population.  The LY3832479 700 mg dose was selected to evaluate the 
lower limit of the confidence interval for clinical IC90. On average, the 3 dose levels are 
expected to provide exposure coverage (as described in Part 1) for approximately 8 weeks.  At 
dose levels greater than 700 mg, LY3832479 provides exposure coverage in at least 90% of 
participant population for at least 8 weeks.
LY3819253 + LY3832479 Combination
To provide coverage of the different but overlapping epitopes on SARS-CoV-2 receptor binding
domain sites, the dose selection rationale for each single mAb intervention in the combination is
the same as for the individual dose rationale for a single mAb intervention described above.  
4.4.
End of Study Definition
A participant is considered to have completed the study if they have completed all required 
phases of the study including the last scheduled assessment shown in the SoA.
The end of the study is defined as the date of last scheduled assessment shown in the SoA for the 
last participant in the trial.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
4 3
5.
St u d y P o p ul ati o n
Pr os pecti ve a p pr o val o f pr ot oc ol  de viatio ns t o recr ui t me nt a n d e nr o ll me nt criteria, als o k n o w n as 
pr ot oc ol  w aivers or e xe m pt i ons, i s n ot per mitte d .
D ue t o t he crit icalit y of part ici pa nt healt h, ver bal i nter vie w of t he p ote ntial partici pa nt, t heir le gal 
a ut h orize d re prese ntati ve, or fa mil y me m ber, ma y be t he s o urce f or pre-e xist i n g c o n diti ons a n d 
me dical hist or y , unless ot her wise s pecifie d wit hi n t he eli gi bilit y crit eria.
5. 1.
I ncl usi o n Criteri a
P arti cipa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of  t h e fol l owi n g criteria a p pl y:
1.
Are ≥1 8 years of a ge at t he ti me of ra n d o mizat i on
2.
F or Part 1 a n d Part 2 partici pa nts:  Resi de nt or staff i n a s kille d n ursi n g or assiste d li vi n g 
facility wi t h at least o ne c o nfir me d case of  S A R S -C o V - 2 detecti o n ≤7 da ys pri or t o 
ra n d omizat i on.
3.
Re pr o d ucti ve a n d C o ntrace pti ve a gree me nts a n d g ui da nce are pr o vi de d i n Sect i on  1 0. 4 , 
A p pe n di x 4 .  C o nt race pti ve use b y me n or w o me n s h o ul d be c o nsiste nt wit h l ocal 
re g ulat i ons f or t h ose partici pati n g i n cli nical st u dies.
4.
A gree t o t he c ollecti on of nasal, mi d -t ur bi nate, or o p har y n geal, a n d nas o p har y n geal 
s wa bs, a n d ve n o us bl o o d as s pecifie d i n t he sc he d ule of act i vities.
5.
H a ve ve n o us access s ufficie nt t o all o w i ntra ve n o us i nf usi ons a n d bl o o d sa m pli n g as per 
t he pr ot oc ol.
6.
T he parti c i pa nt or le gall y a ut h orize d re prese ntati ve gi ve s si g ne d i nf or me d c o nse nt as 
descri be d i n Secti o n  1 0. 1. 3 , A p pe n di x 1 , w hic h i ncl u des c o m plia nce with t he 
re q uire me nts a n d restricti ons liste d i n t he i nf or me d c o nse nt f or m (I C F) a n d i n t his 
pr ot oc ol .
P art 3 p artici p a nts o nl y:
1 9. Resi de nt or staff i n a skil le d nursi n g or a ssiste d li vi n g facility w h o sati sfies at least o ne 
of  t he f oll owi n g at t he ti me of scree ni n g

Are ≥ 6 5 y ears of a ge

Ha ve a B MI ≥ 3 5

Ha ve c hr o nic ki d ne y disease

Ha ve t y pe 1 or t y pe 2 dia betes

Ha ve i m m u n os u p pressi ve disease

Are c urre nt l y recei vi n g i m m u n os u p pressi ve treat me nt, or

Are ≥ 5 5 y ears of a ge A N D ha ve
o
car dio vasc ular di sease, O R
o
h y perte nsi o n, O R
o
c hr o nic o bstr ucti ve p ul m o nar y  disease or ot her c hr o nic res pirat or y disease
N ote: B MI i s r o u n de d t o t he nearest w h ole n u m ber, f or e xa m ple, 3 4. 5 i s r o u n de d t o 3 5.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
4 4
2 0. P osi tive S A R S -C o V -2 test a n d i nf usi o n wi t hi n 1 0 da ys of s y m pt o m o nset, O R p osi ti ve 
S A R S -C o V -2 test a n d i nf usi o n wi t hi n 1 0 da ys of testi n g if as y m pt o mat ic
5. 2.
E xcl usi o n Criteri a
P arti cipa nts are e xcl u de d fr o m  t he st u d y if a n y of t he f o llo wi n g cri t eria a p pl y:
7.
F or Parts 1 a n d 2, r ec o vere d fr o m C O VI D -1 9 diseas e or as y m pt o mat ic i nfecti on
8.
F or P art s 1 a n d 2, a pri or hi st or y of a p ositive S A R S -C o V -2 ser ol o g y test
9.
F or Parts 1 a n d 2, a hist or y  of C o n valesce nt C O VI D -1 9 pl as ma treat me nt
1 0. Are a n i n pat ient  i n h os pi t al
1 1. F or Parts 1 a n d 2, p art ici pati on i n a pre vi o us S A R S-C o V -2 vacci ne trial or recei ve d an 
a p pr o ve d S A R S -C o V - 2 vacci ne
1 2. F or Parts 1 a n d 2, p re vi o us recei pt of S A R-C o V - 2-s pecific m on ocl o nal  a nti b o dies
1 3. H a ve part ici pate d, wit hi n t he last 3 0 da ys, i n a cli nical st u d y  in v o l vi n g a n i n vesti gati onal 
pr o d uct.  If t he pre vi o us i n vest i gati onal pr o d uct has a l o n g half -life, 5 half-li ves or 
3 0 d a y s ( w hic he ver is lo n ger) s h o ul d ha ve passe d . T his crit erio n d oes n ot a p pl y  t o 
pr o d ucts descri be d i n Cri teria 9, 1 1, a n d 1 2.  
1 4. Are pre g na nt or breast fee di n g
1 5. A r e c o nc urre nt l y e nr olle d i n a n y ot her t ype of me dical researc h j u d ge d n ot t o be
scie ntificall y or me dicall y c om pati ble wit h t his st u d y
1 6. Ha ve k n o w n aller gies t o relate d c o m p o u n ds of L Y 3 8 1 9 2 5 3 , L Y3 8 3 2 4 7 9 or a n y  
c o mp o ne nts of t he f or m ulat i on
1 7. S us pecte d or pr o ve n seri o us, acti ve bacterial, f u n gal, viral, or ot her i nfect i on t hat i n t he 
o pi ni o n of t he i n vest i gat or c o uld c o nsti t ute a ris k w he n ta ki n g i n vest i gati onal pr o d uct
1 8. Ha ve a n y seri o us c o nc o mit a nt s yste mic disease, c o n diti on or dis or der t hat, i n t he 
o pi ni o n of t he i n vest i gat or, s h o ul d precl u de partici pati o n i n t his st u d y.
5. 3.
Lifest yle C o nsi der ati o ns
Re pr o d ucti ve a n d C o ntrace pti ve g ui da nce is pr o vi de d i n Secti o n  1 0. 4 , A p pe n di x 4.
P arti cipa nts s h o ul d r ef rai n fr om d o nati n g bl o o d or bl o o d pr o d ucts fr o m t he ti me of t heir 
scree ni n g visit u ntil 9 0 da ys f o ll owi n g t he last d ose of st u d y i nter ve nti on.
5. 4.
Scree n F ail ures
Scree n fail ures are defi ne d as part ici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y b ut are 
n ot s u bse q ue ntl y e nr olle d i n t he st u d y. A mi ni mal set of scree n fail ure i nf or mat i on is re q uire d t o 
e ns ure tra ns pare nt re p orti n g of scree n fail ure partici p a nts t o meet t he C o ns oli date d Sta n dar ds of 
Re p orti n g Trials p u blis hi n g re q uire me nts a n d t o res p o n d t o q ueries fr o m re g ulat or y  a ut h orities. 
Mi ni mal i nf or mat i on i ncl u des de m o gra p h y, scree n fail ure details, eli gi bility cri t eria, a n d a n y 
serio us a d verse e ve nt ( S A E).

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Individuals who do not meet the criteria for participation in this study (screen failure) may not be 
rescreened.  Re-evaluation of venous access does not constitute rescreening and is allowable 
within the screening window.

C O N FI D E N TI A L
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4 6
6.
St u d y I nter ve nti o n
St u d y  i nter ve nt i on is defi ne d as a ny i n vesti gati onal i nter ve nt i on (s), mar kete d pr o d uct(s), 
pl ace b o , or m e dical de vice(s) i nte n de d t o be a d mi nistere d t o a st u d y partici pa nt acc or di n g t o t he 
st u d y pr ot oc ol .
6. 1.
St u d y I nter ve nti o n(s) A d mi nistere d
Eac h partici pa nt will recei ve a si n gle I V i nf usi o n of eit her place b o , L Y 3 8 1 9 2 5 3 , or a 
c o m bi nat i on of L Y 3 8 1 9 2 5 3 a n d L Y 3 8 3 2 4 7 9 .
St u d y P art
1 & 2
1
2 & 3
2
( Pre ve nti o n 
O nl y)
2 & 3
( Treat me nt o nl y)
I nter ve nti o n 
N a me
Place b o
L Y 3 8 1 9 2 5 3 
L Y 3 8 1 9 2 5 3
L Y 3 8 1 9 2 5 3 + 
L Y 3 8 3 2 4 7 9
L Y 3 8 1 9 2 5 3 + 
L Y 3 8 3 2 4 7 9
D ose 
F or m ul ati o n
0. 9 % s o di u m 
c hl ori de s ol uti o n
S ol uti o n
D os a ge 
Le vel(s)
N ot a p plica ble
4 2 0 0 m g
7 0 0 m g
3 5 0 m g + 
7 0 0 m g
7 0 0 m g + 
1 4 0 0 m g
Use
Place b o
E x peri me ntal
I M P a n d 
NI M P
I M P
I M P
S o urci n g
C o m merciall y 
a vaila ble 0. 9 % 
s o di u m c hl ori de 
s ol uti o n
Fr o m Lill y
P ac k a gi n g 
a n d L a beli n g
C o m merciall y 
a vaila ble 0. 9 % 
s o di u m c hl ori de 
s ol uti o n
St u d y I nter ve nti o n will be pr o vi de d i n glass vials a n d will be 
la bele d a p pr o priatel y
A b bre viati o ns:  I M P = i n vesti gati o nal me dici nal pr o d uct; I V = i ntra ve n o us ; NI M P = n on- i n vesti gati o nal me dici nal 
pr o d uct .
T he i nf usi o n rate m a y be re d uce d as dee me d necessar y if an i nf usi on react i on is o bser ve d 
( Sectio n  6. 1. 1. 2 ).  Partici pa nts will be m o nit ore d f or si g ns a n d s y m pt o ms of i nf usi on react i on

e ver y 3 0 mi n utes d uri n g t he i nf usi o n or at least o nce if i nf usi on ti me is < 3 0 mi n utes, a n d

f or at least 1 h o ur after c o m plet i on of t he i nf usi o n. 
T he site m ust ha ve res uscitati o n e q ui p me nt, e mer ge nc y dr u gs , a n d a p pr o priatel y trai ne d sit e staff 
a vaila ble d uri n g t he i nf usi o n a n d f or at least 1 h o ur after t he c o m plet i on of t he i nf usi o n. 
I nf usi on i nf or mati on ma y be f ou n d i n t he D osi n g S ol uti o n Pre parati o n I nstr ucti o ns.

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6.1.1.
Special Treatment Considerations
6.1.1.1.
Premedication for Infusions
Premedication for infusions is not planned.  However, if the participant has a medical history 
suggesting a potential benefit from premedication, the study investigator(s) or qualified designee
should determine the appropriate premedication.
The investigators and sponsor may decide to use premedication if the frequency of infusion 
reactions among participants warrants it.
If minor infusion reactions are observed, administration of acetaminophen, 500-mg to 1000-mg, 
antihistamines and/or other appropriately indicated medications may be given prior to the start of 
infusions for subsequent participants.
The decision to implement premedication for infusions in subsequent participants will be made 
by the investigator and sponsor and recorded in the study documentation.
Any premedications given will be documented as a concomitant therapy.
6.1.1.2.
Management of Infusion Reactions
All participants should be monitored closely, as there is a risk of infusion reaction and 
hypersensitivity (including anaphylaxis) with any biological agent.
Symptoms and Signs
Symptoms and signs that may occur as part of an infusion reaction include, but are not limited to 
fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash 
including urticaria, pruritus, myalgia, and dizziness.
Infusion-related reactions severity will be assessed and reported using the Division of AIDS
(DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected 
Version 2.1 (July 2017).
This table describes the severity of reactions according to DAIDS.
Parameter
Mild
Moderate
Severe
Severe and 
Potentially 
Life-threatening
Acute Allergic 
Reaction
Localized urticaria 
(wheals) with no 
medical 
intervention 
indicated
Localized urticaria with 
intervention indicated 
OR 
Mild angioedema with 
no intervention indicated
Generalized Urticaria 
OR
Angioedema with 
intervention indicated 
OR
Symptoms of mild 
bronchospasm
Acute anaphylaxis 
OR 
Life-threatening 
bronchospasm 
OR
Laryngeal edema
Cytokine 
Release 
Syndromea
Mild signs and 
symptoms 
AND
Therapy (that is, 
antibody infusion)
interruption not 
indicated
Therapy (that is, 
antibody infusion) 
interruption indicated
AND
Responds promptly to 
symptomatic treatment
OR
Prolonged severe 
signs and symptoms 
OR
Recurrence of 
symptoms following 
initial improvement
Life-threatening 
consequences 
(for example, 
requiring pressor or 
ventilator support)

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Prophylactic 
medications indicated 
for ≤24 hours
a
A disorder characterized by nausea, headache, tachycardia, hypotension, rash, and/or shortness of breath.
Source:  DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 (July 
2017).
Site Needs
The clinical site should have necessary equipment and medications for the management of any 
infusion reaction, which may include but is not limited to oxygen, IV fluids, epinephrine, 
acetaminophen and antihistamine.
Management of Infusion Reactions
Investigators should determine the severity of the infusion reaction and manage infusion 
reactions based on standard of care and their clinical judgment.  If an infusion reaction occurs, 
then supportive care should be used in accordance with the signs and symptoms.
If a participant permanently discontinues from study intervention, they should complete AE 
monitoring and other procedures as stated in the SoA.
6.2.
Preparation/Handling/Storage/Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention.
To protect blinding, the interventions must be prepared by an unblinded site staff qualified to 
prepare study intervention who are not involved in any other study-related procedures.  
Instructions for preparation will be provided by the sponsor.
Only participants enrolled in the study may receive study intervention and only site staff may 
supply or administer study intervention.
All study intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access limited 
to the investigator and authorized site staff.
The investigator, institution, contracted pharmacist, or another appropriate individual who is 
under the supervision of the investigator is responsible for study intervention accountability, 
reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition 
records).
Further guidance and information for the final disposition of unused study interventions are 
provided in the pharmacy manual.
6.3.
Measures to Minimize Bias: Randomization and Blinding
Randomization
Participants who meet all criteria for enrollment will be randomized on Day 1 as follows: 

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
In Part 1, 1:1 to double-blind treatment 

In Part 2, will allocated as follows: 

Prevention Cohort:  1:1:1 to double blinded treatment

Treatment Cohort:  1:1, as described in Part 2 Treatment Cohort below

In Part 3, 1:1 to open label treatment
To achieve between-group comparability, block randomization within each facility will be used.  
Randomized participants within the facility will be stratified by role within the facility (resident 
versus facility staff), by sex, and whether or not the participant received a SARS-CoV-2 vaccine 
prior to screening (in Part 3 only).
All participants will be centrally randomized to study intervention using an Interactive Web 
Response System (IWRS). Before the study is initiated, the log in information and directions for 
the IWRS will be provided to each site.
Blinding
Part 1 and Part 2 Prevention Cohort
Part 1 and Part 2 are blinded.  Neither participants, nor investigators, nor the sponsor study team 
will be aware of treatment assignments prior to the final database locks at the conclusion of the 
study, except as described in the following note.
Note:  It is possible that some participants will have the SARS-CoV-2 negative result on the 
screening point of care test, but could be positive on the baseline SARS-CoV-2 PCR test.  The 
results from the baseline PCR test will not be available until after the participant is randomized.  
Once positive results are known from the baseline PCR test, these participants will be unblinded 
and have the option to continue to be followed for safety according to the Prevention Cohort 
SoA. This table describes general procedures for unblinding.
Unblinding (IWRS)

Emergency unblinding for adverse events may be performed through the 
IWRS.  All actions resulting in an unblinding event are recorded and 
reported by the IWRS

In case of an emergency, the investigator has the sole responsibility for 
determining if unblinding of a participants’ intervention assignment 
is warranted

Participant safety must always be the first consideration in making such a 
determination.  However, the investigator should make all attempts to 
contact the Medical Monitor in advance of unblinding

If a participant’s intervention assignment is unblinded, the sponsor must be 
notified immediately after breaking the blind even if consultation occurred 
in advance

The date and reason that the blind was broken must be recorded in the 
source documentation. 

Participants who test negative at screening POC testing, then test positive at 
baseline PCR testing, will be unblinded.  Unblinding is recorded and 
reported by the IWRS. 
Abbreviations:  IWRS = interactive web-response system.
If an investigator, site staff performing assessments, or participant is unblinded while the 
infusion is ongoing, the participant must be discontinued from the study intervention and the 

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i nf usi on st o p pe d.  If a n y a m o u nt of st u d y int er ve nti o n was a d mi nistere d, f o ll ow pr oce d ures 
acc or di n g t o t he S o A as descri be d i n Secti o n  7. 1 .
P art 2 Tre at me nt C o h ort
T he Part 2 Treat me nt C o h ort is bli n de d.  Neit her partici pa nts, n or i n vest i gat ors, n or t he s p o ns or 
st u d y t e a m will be a ware of treat me nt assi g n me nts pri or t o t he fi nal data base l oc ks at t he 
c o nclusi o n  of t he st u d y.
If t he partici pa nt is assi g ne d t o t he Part 2 treat me nt c o h ort base d o n a p ositi ve P O C test, t he 
parti ci pa nt will be ra n d o mize d t o o ne of t w o ar ms.   T he partici pa nt will be i nf or me d t hat t he y  are 
recei vi n g acti ve st u d y int er ve nt i on (t hat is, n ot place b o). 
P art 3
Part 3 i s o pe n la bel.  
6. 4.
St u d y I nter ve nti o n C o m pli a nce
P arti cip a nts will recei ve st u d y  int er ve nt i on di rectl y fr om t he i n vest i gat or or q ualifie d desi g nee, 
u n der me dical s u per visi o n.  T he date a n d ti me of d osi n g will  be rec or de d i n t he s o urce 
d oc u m e nts a n d rec or de d i n t he case re p ort f or m (C R F ).
6. 5.
C o nc o mit a nt T her a p y
C o nc o mit a nt T her a p y
P arti cipa nts s h o ul d be treate d acc or di n g t o sta n dar d of care, e ve n as it e v o l ves, a n d me dicati ons 
ma y be part of t he treat me nt para di g m.
R e mdesi vi r ma y be i nitiate d as sta n dar d of care f or partici pa nt s re q uirin g h os pi talizatio n . 
If t he l ocal sta n dar d of care per writte n p olicies or g ui deli nes (t hat i s, n ot just a n i n di vi d ual 
cli nicia n decisi o n) i ncl u des i n vest i gati onal a ge nts t o treat C O VI D- 1 9, t he n starti n g t hese d uri n g 
t he st u d y is per mitte d, b ut ma y re q uire a d dit i onal s afet y m o nit ori n g.
C o n valesce nt C O VI D -1 9 pl as ma treat me nt is n ot all o we d, e xce pt i n h os pitalize d partici pa nts.
Va cci nes for S A R S -C o V -2 s h o ul d n ot be use d pri or t o Wee k 8 of t he e val uat i on peri o d f or t he 
pre ve nt i on c o h ort of  P art 2.
A n y me dicat i on, i n vest i gati onal a ge nt, or vacci ne, i ncl u di n g o ver t he c o u nter or prescri pt i on 
me dici nes, vita mi ns, a n d/ or her bal s u p ple me nts , or ot her s pecific cate g ories of i nterest (s uc h as 
c o n valesce nt C O VI D -1 9 pl as ma treat me nt) t hat t he partici pa nt is recei vi n g at t he ti me of 
e nr o ll me nt or recei ves d uri n g t he st u d y m ust be rec or de d al o n g wit h

Reas o n f or use

Dates of a d mi nistrati o n i ncl u di n g start a n d e n d dates, a n d

D osa ge i nf or mati o n i ncl u di n g d ose a n d fre q ue nc y f or c o nc o mita nt t hera p y  of s pecial 
i nterest.
Aceta mi n o p he n a n d c ortic oster oi d use are per mitte d at a n y t i me d uri n g t he st u d y.

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Other concomitant medication may be considered on a case-by-case basis by the investigator in 
consultation with the sponsor if required.
The sponsor should be contacted if there are any questions regarding concomitant or prior 
therapy.
6.6.
Intervention after the End of the Study
No continued access is planned after completion of this study, as additional efficacy would be 
needed to demonstrate continued access criteria.

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7.
Disc o nti n u ati o n of St u d y I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al
T hese secti o ns descri be reas o ns f or a partici pa nt’s

p er m a ne nt or te mp orar y  disc o nti n uati on of st u d y  dr u g, or

di sc o nti n uati on ( wi t hdra wal) fr o m  t he st u d y.
Di sc o nti n uatio n of  s pecific sites or of t he trial as a w h ole are ha n dle d as part of re g ulat or y, 
et hical, a n d trial o versi g ht c o nsi derat i ons i n Secti on  1 0. 1. 9 . A p pe n di x 1.
7. 1.
Disc o nti n u ati o n of St u d y I nter ve nti o n
I n rare i nsta nces, it ma y be necessar y for a partici pa nt t o per ma ne nt l y disc o nti n ue ( defi niti ve 
di sc o nti n uati on) st u d y i nter ve nt i on . If st u d y i nter ve nti on is defi niti vel y disc o nti n ue d, t he 
parti ci pa nt will r e mai n i n t he st u d y f or fol l ow- u p a n d a n y furt her e val uat i ons as descri be d i n t he 
S o A.
7. 2.
P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al fr o m t he St u d y
A partici pa nt ma y wit h dra w fr o m t he st u d y:

at a n y ti me at his/ her o w n re q uest

at t he re q uest of his/ her desi g nee (f or e xa m ple, le gal a ut h orize d re prese ntati ve)

at t he discreti o n of t he i n vest i gat or f or safety,  be ha vior al , c o mplia nce, or a d mi nistrati ve 
reas o ns

if t he partici pa nt bec ome s pre g na nt d uri n g t he st u d y

if e nr oll me nt i n a n y ot her cli nical st u d y i n v ol vi n g a n i n vesti gati onal pr o d uct or 
e nr o ll me nt i n a n y ot her t y pe of me d ical researc h j u d ge d n ot t o be scie ntificall y or 
me dicall y c o m pat i ble wit h t his st u d y
Di sc o nti n uatio n is e x pecte d t o be u nc o m m o n.
At  t he ti me of disc o nti n ui n g fr o m t he st u d y, if p ossi ble, a n earl y disc o nt i n uati on visit s h o uld be 
c o n d ucte d, as s h o w n i n t he S o A.  See t he S o A f or data t o be c ollecte d at t he ti me of st u d y 
di sc o nti n uati on a n d f o ll ow- u p a n d f or a n y  furt her e val uat i ons t hat nee d t o be c o m p lete d.  T he 
parti ci pa nt will be per ma ne nt l y disc o nti n ue d b ot h fr om t he st u d y int er ve nt i on a n d fr o m t he st u d y 
at t hat ti me.
If t he partici pa nt, or t he partici pa nt’s le gal a ut h orize d re prese ntati ve, wi t hdra ws c o nse nt f or 
di s clos ure of f ut ure i nf or mat i on, t he s p o ns or ma y retai n a n d c o nti n ue t o use a n y data c ollecte d 
bef ore s uc h a wit h dra wal o f c o nse nt.  If a partici pa nt wit h dra ws fr o m t he st u d y, he/s he or t he 
parti ci pa nt’s le gal a ut h orize d re prese ntati ve, ma y re q uest destr uctio n of  a n y sa m ples ta ke n a n d 
n ot te ste d, a n d t he i n vesti gat or m ust d oc u me nt t his i n t he site st u d y rec or ds.
7. 2. 1.
Disc o nti n u a ti o n of I n a d verte ntl y E nr olle d P artici p a nts
If t he s p o ns or or i n vesti gat or i de ntif y a partici pa nt w h o di d n ot meet e nr oll me nt criteria a n d was 
i na d verte ntl y e nr olle d, t he n t he parti ci pa nt s h o uld be disc o nt i n ue d fr om st u d y int er ve nt i on u nless 

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t here are e xte n uati n g circ u msta nces t hat ma ke it me dicall y necessar y f or t he parti ci pa nt t o 
c o nti n ue st u d y int er ve nti on.  
If t he i n vesti gat or a n d t he s p o ns or C R P/ C R S a gree it is me dicall y a p pr o priate t o c o nti n ue, t he 
i n vesti gat or m ust o btai n d oc u me nte d a p pr o val fr o m t he s p o ns or C R P/ C R S t o all o w t he 
i na d verte ntl y e nr olle d partici pa nt t o c o nti n ue i n t he st u d y wi t h or wit ho ut treat m e nt wit h 
i n vesti gati onal pr o d uct.
S af et y f oll ow u p i s as o utli ne d i n 

Secti o n  1. 3 ( Sc he d ule of Acti vities) 

Secti o n  8. 2 ( Safety Assess me nts), a n d 

Secti o n  8. 3 ( A d verse E ve nts a n d Seri o us A d verse E ve nts).
7. 3.
L ost t o F oll o w u p
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if  he or s he re peate dl y fails t o ret ur n f or 
sc he d ule d visits a n d is u na ble t o be c o ntacte d b y  t he st u d y sit e. Si te pers o n nel are e x pecte d t o 
ma ke dili ge nt atte m pts t o c o ntact partici pa nt s w h o fail t o ret ur n f or a sc he d ule d visit or were 
ot her wi se u na ble t o be f oll owe d u p b y t he site.
Si te pers o n nel, or a n i n de pe n de nt t hir d part y, will atte m pt t o c ollect t he vital stat us of t he 
parti ci pa nt wit hi n le gal a n d et hical b o u n daries f or all partici pa nts w h o recei ve d i n vest i gati onal 
pr o d uct. P u blic s o urces ma y be searc he d f or vital stat us i nf or mati o n.
If vit al stat us is 
deter mi ne d t o be d ecease d, t his will be d oc u me nte d a n d t he partici pa nt will n ot be c o nsi dere d 
l ost t o f ollo w - u p. S p o ns or pers o n nel will n ot be i n v o l ve d i n a n y atte m pts t o c ollect vital stat us 
i nf or mat i on.

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8.
St u d y Assess me nts a n d Pr oce d ures
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A.
Pr ot oc ol wai vers or e xe m pt i ons are n ot all o we d.
M o ni t ori n g of bli n de d safety data will c o nt i n ue t hr o u g h o ut t he st u d y a n d will be c o n d ucte d b y 
bli n de d st u d y  tea m me m bers.  Details of t he bli n de d s afet y re vie ws, i ncl u di n g t he fre q ue nc y a n d 
a p pr o xi mate ti mi n g, are s pecifie d i n t he trial le vel safet y re vie w pla n.
I mme diate safet y c o ncer ns s h o ul d be disc usse d wit h t he s p o ns or i m me diatel y u p o n occ urre nce or 
a ware ness t o deter mi ne if t he partici pa nt s h o u l d c o nti n ue or disc o nti n ue st u d y int er ve nt i on.
A d here nce t o t he st u d y  desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A, is esse ntial 
a n d re q uire d f or st u d y c o n d uct.
All scree ni n g e val uati ons m u st be c o mplete d a n d re vie we d t o c o nfir m t hat p ote ntial part ici pa nts 
meet all eli gi bilit y criteria.  T he i n vesti gat or will mai ntai n a scree ni n g l o g t o rec or d details of all 
parti ci pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or scree ni n g fail ure, as 
a p plica ble.
8. 1.
Effic ac y Assess me nts
8. 1. 1.
S A R S -C o V -2 V ir al S w a b a n d Ser ol o g y
F or details c o ncer ni n g viral s wa b, see P har mac o d y na mic s ( Sectio n  8. 6 ). I n Part 1, a n y p osi tive 
res ult fr o m a baseli ne S A R S -C o V -2 test ( N P or nasal s w a b) will res ult i n t he partici pa nt bei n g 
decl are d S A R S -C o V - 2 p osit i ve i n t he a nal ysis p o p ulati ons. I n Part 2, the res ult fr o m t he 
scree ni n g P O C test a n d baseli ne S A R S -C o V -2 test are pla n ne d t o be use d t o defi ne S A R S -C o V -
2 stat us f or t he a nal ysis p o p ulat i ons.  
N asal s wa bs are pla n ne d d uri n g t he e val uat i on a n d p ost -e val uat i on peri o d at  ti mes descri be d i n 
t he S o A.  H o we ver, i n t he e ve nt nasal s wa bs ca nn ot be s u p plie d , t he S p o ns or ma y s u bst itut e wit h
or o p har y n geal , mi d -t ur bi nate or nas o p har y n geal s wa bs. F or i nstr ucti o ns relate d t o perf or mi n g 
t he nas o p har y n geal, mi d -t ur bi nate, nasal, or or o p har y n geal, s wa b, see g ui da nce pr o vi de d b y 
S p o ns or .
F or Part 3, a n y  p ositive res ult fr o m a baseli ne S A R S -C o V -2 test ( N P) will res ult i n t he 
parti ci pa nt bei n g declare d S A R S -C o V -2 p osit i ve i n t he a nal ysis p o p ulati o ns.  N P s wa bs are 
pl a n ne d d uri n g t he e val uat i on a n d p ost -e val uat i on peri o d at ti mes descri be d i n t he S o A.  
F or details c o ncer ni n g viral ser o l og y , see P har mac o d y na mics ( Secti o n 8. 6 ).
8. 1. 2.
P artici p a nt S y m pt o ms Q uesti o n n aire
P articipa nts will be as ke d a b o ut t he prese nce or a bse nce of s y m pt o ms a n d si g ns ass ociate d wit h 
C O VI D - 19 e x perie nce d d uri n g t he past 2 4 h o urs , at t he ti me p o i nts descri be d i n t he S o A.  
Si g ns a n d s y m pt o m s ass ociate d wit h C O VI D-1 9 s h o ul d n ot be ca pt ure d as A Es , u nless mor e 
se vere t ha n e x pecte d.  See Secti o n 1 0. 3. 1 . for a d di tio n al inf or m atio n A E defi nit i ons use d i n t his 
st u d y.
S y m pt o m s i ncl u de

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
shortness of breath with movement

shortness of breath at rest

cough 

chest pain or discomfort with breathing

feeling feverish

chills 

sore throat 

muscle or body aches and pain 

fatigue or loss of energy

headache

nausea

diarrhea

vomiting

loss of appetite

loss of taste, and

loss of smell.
Participants requiring a legally authorized representative to provide signed informed consent will 
not be asked to report the presence or absence of symptoms. Only symptoms that may be 
observed by site staff other than the participant will be recorded, including

shortness of breath with movement

shortness of breath at rest

cough 

diarrhea, and

vomiting.
8.2.
Safety Assessments
Planned time points for all safety assessments are provided in the SoA.
8.2.1.
Physical Examinations, Clinical Signs and Symptoms 
A complete physical examination and medical history (including preexisting clinical signs and 
symptoms) will be performed at the screening visit. This examination excludes pelvic, rectal, 
and breast examinations unless clinically indicated.
A symptom-directed physical examination will be performed at other visits, as specified in the 
SoA and as clinically indicated.
Investigators should pay special attention to clinical signs related to COVID-19, to ongoing 
medical conditions and to previous serious illnesses.
8.2.2.
Vital Signs
Vital signs will be measured at rest as specified in the SoA.  Vital signs include

body temperature

blood pressure

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
p ul s e r at e

res pirati on rate

sat uratio n of  p erip h er al  o x y ge n, a n d

su p ple me ntal  o x yge n fl o w rate, Fi O 2 if k n o w n, a n d met h o d of deli ver y, if a p plica ble.
If a vaila ble d uri n g t he st u d y, o ptio nal  r e mot e vi t al stat us mo ni t orin g m a y be use d t o o btai n vital 
data.
A d dit i onal vit al si g ns ma y be meas ure d d uri n g t he st u d y if warra nte d, as deter mi ne d b y t he 
i n vesti gator.
8. 2. 3.  
Cli nic al S afet y L a b or at or y Assess me nts
See Secti o n  1 0. 2 , A p pe n di x 2 f or t he list of cli nical la b orat or y tests t o be perf or me d a n d t he S o A 
f or t he ti mi n g a n d fre q ue nc y.  All pr ot oc ol -re q uire d la b orat or y assess me nts, as defi ne d i n 
A p pe n di x 2, m ust be c o n d ucte d i n acc or da nce wit h t he l a b orat or y ma n ual a n d t he S o A.
Cli nicall y si g nifica nt a b n or mal la b orat or y  fi n di n gs are t h ose w hic h are n ot ass ociate d wit h t he 
u n derl yi n g disease, u nless j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he 
p artici pa nt's c o n dit i on.
All la b orat or y tests wit h val ues c o nsi dere d cli nicall y si g nifica ntl y a b n or mal d uri n g partici pat i on 
i n t he st u d y or wit hi n 2 8 da ys after t he d ose of st u d y int er ve nt i on s h o ul d be re peate d u ntil t he 
val ues ret ur n t o n or mal or baseli ne or are n o l o n ger c o nsi dere d cli nicall y si g nifica nt b y t he 
i n vesti gat or or s p o ns or.
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne withi n a perio d of  ti me j u d ge d reas o na ble b y t he 
i n vesti gat or, t he eti ol o g y s h o uld b e i de ntifie d a n d t he s p o ns or n otifie d.
T he i n vest i gat or m ust re vie w t he la b orat or y res ults, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y in t he C R F.
T he l a b orat or y re p orts must be file d wit h t he s o urce d oc u me nts. 
If la b orat or y val ues fr o m n o n- pr ot oc ol  s pecifie d la b orat or y assess me nts perf or me d at a l ocal 
la b orat or y t hat re q uire a c ha n ge i n partici pa nt ma na ge me nt or are c o nsi dere d cli nicall y 
sig nifica nt b y t he i n vest i gat or (i.e., S A E or A E), t he n t he A E or S A E will be rec or de d b y t he 
i n vesti gat or i n t he C R F.
Pre g n a nc y Testi n g
W o me n of c hil d beari n g p ote ntial ( W O C B P) m ust u n der g o pre g na nc y  testi n g acc or di n g t o t he 
S o A.
8. 2. 4.
H os pit aliz ati o n e ve nts   
If a partici p a nt is a d mitte d t o t he h os pit al, t he participa nt will re mai n i n t he st u d y  a n d fol l ow t he 
pr oce d ures o utli ne d i n t he S o A.  H os pitalizat i on is defi ne d as ≥2 4 h o urs of ac ute care.
T he date of h os pitalizati o n e ve nts will be rec or de d i n t he C R F a n d i ncl u des

h os pi talizatio n

e mer ge nc y r o o m visit 

i nte nsi ve care u nit a d mitta nce

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
ext e n de d care facilit y a d mitta nce , a n d

d isc har ge f or a n y of t he a b o ve.
8. 2. 5.
Pr oce d ures of S peci al I nterest
I n h os pitalize d partici pa nts, cli nical stat us a n d c o nc o mita nt pr oce d ures of s pecial i nterest will be 
rec or de d i n t he C R F a n d i ncl u de c o nsci o us ness stat us usi n g alert, c o nf usi o n , ver bal, pai n, 
u nres p o nsi ve scale ( A C V P U), li mitati on o n acti vit ies d ue t o C O VI D-1 9 a n d re q uire me nts f or: 

o n g oi n g h os pital me dical care

s u p ple me ntal o x yg e n

n o n- i n vasi ve ve ntilati on or a hi g h fl o w o x y ge n de vice 

mec ha nical ve nt ilati on

e xtrac or p oreal me m bra ne o x y ge nat i on , or

a d ditio nal  or ga n s u p p ort (e. g. press ors, re nal re place me nt).
8. 3.
A d verse E ve nts a n d Seri o us A d verse E ve nts
A d verse e ve nts wil l be re p orte d b y  t he partici pa nt ( or, w he n a p pr o priate, b y a care gi ver, 
s urr o gate, or t he partici pa nt's le gall y a ut h orize d re prese ntati ve).
T he i n vest i gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi nit i on of a n A E or S A E a n d re mai n res p o nsi ble f or f o ll owi n g 
u p A Es t hat are seri o us, c o nsi dere d relate d t o t he st u d y  int er ve nt i on or st u d y  pr oce d ures, or t hat 
ca use d t he partici pa nt t o disc o nt i n ue t he st u d y int er ve nt i on or st u d y  (see Secti o n 7 ).
8. 3. 1.
Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n
All A Es a n d S A Es will be c ollecte d fr o m t he ti me of sig ni n g of  t he I C F u nt il part ici pati on i n 
st u d y has e n de d .
A d verse e ve nts t hat be gi n bef ore t he start of st u d y int er ve nt i on b ut after si g ni n g of t he I C F will 
be rec or de d o n t he A d verse E ve nt C R F.
Alt h o u g h all A Es after si g ni n g t he I C F are rec or de d b y t he site i n t he C R F/electr o nic data e ntr y, 
S A E re p orti n g t o s p o ns or wit hi n t he re q uire d t i mefra me be gi ns after t he parti ci pa nt has si g ne d 
t he I C F a n d has recei ve d st u d y dr u g.  H o we ver, if a n S A E occ urs after si g ni n g t he I C F, b ut pri or 
t o recei vi n g st u d y int er ve nt i on , it nee ds t o be re p orte d wit hi n t he re q uire d ti mefra me O N L Y if i t 
is c o nsi dere d reas o na bl y p ossi bl y relate d t o st u d y pr oce d ures.
All S A Es will be rec or de d a n d re p orte d t o t he s p o ns or or desi g nee i m me diatel y a n d u n der n o 
circ u msta nce s h o uld t hi s e xcee d 2 4 h o urs, as i n dicate d i n Secti o n 1 0. 3. 4 , A p pe n di x 3. T he 
i n vesti gat or will s u b mit a n y u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs of i t bei n g 
a vaila ble.
I n vesti gat ors are n ot o bli gate d t o acti vel y see k A Es or S A Es aft er c o nclusi o n  of t he st u d y 
parti ci pat i on . H o we ver, if t he i n vesti gat or lear ns of a n y S A E, i ncl u di n g a deat h, at a n y ti me after 
a partici pa nt has bee n disc har ge d fr o m t he st u d y , a n d he/s he c o nsi ders t he e ve nt t o be reas o na bl y 
r elate d t o t he st u d y i nter ve nt i on or st u d y parti ci patio n , t he i n vesti gat or m ust pr o m ptl y n otif y  t he 
s p o ns or.

C O N FI D E N TI A L
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8. 3. 2.
Met h o d of Detecti n g A Es a n d S A Es
T he m et h o d of rec or di n g, e val uat i n g, a n d assessi n g ca usality of A E a n d S A E a n d t he pr oce d ures 
f or c o mplet i n g a n d tra ns mitti n g S A E re ports are pr o vi de d i n Sect i on  1 0. 3 , A p pe n di x 3.
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A Es a n d/ or S A Es.  O pe n -e n de d a n d 
n o n- lea di n g ver bal q uest i oni n g of t he partici pa nt is t he preferre d met h o d t o i n q uire a b o ut A E 
occ urre nces.
8. 3. 3.
F oll o w -u p of A Es a n d S A Es
After t he i nit ial A E/ S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll ow eac h partici pa nt 
at s u bse q ue nt visits/c o nta cts. All S A Es will  be fol l owe d u ntil res o l uti on, sta bilizat i on, t he e ve nt 
is ot her wise e x plai ne d, or t he partici pa nt is l ost t o f o ll ow- u p (as defi ne d i n Sect i on  7. 3 ). F urt her 
i nf or mat i on o n f o ll ow- u p pr oce d ures is pr o vi de d i n Secti o n  1 0. 3 , A p pe n di x 3 .
8. 3. 4.
Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificat i on b y t he i n vest i gat or t o t he s p o ns or of a S A E is esse ntial s o t hat le g al 
o bli gat i ons a n d et hical res p o nsi bilit ies t o war ds t he safety of  partici pa nts a n d t he safet y of  a st u d y 
i nter ve nt i on u n der cli nical i n vesti gat i on are m et.
T he s p o ns or has a le gal res p o nsi bilit y t o n otif y b ot h t he lo c al  re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of  a st u d y int er ve nt i on u n der cli nical i n vesti gati o n. T he 
s p o ns or will c om p l y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety re p ortin g t o 
t he re g ulat or y a ut h orit y, I nstituti o nal  Re vie w B oar ds (I R B)/I n de pe n de nt Et hics C o m mittees 
(I E C), a n d i n vesti gat ors.
A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y re p ort descri bi n g a S A E or ot her s pecific 
safety i nf or mati on (e. g., s u m mar y  or listi n g of S A Es) fr o m t he s p o ns or will re vie w a n d t he n file 
it wit h t he I B a n d will n otif y t he I R B/I E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
8. 3. 5.
Pre g n a nc y
A lth o u g h n or mal pre g na nc y  is n ot a n a d verse e ve nt, details of all pre g na ncies i n fe male 
parti ci pa nts will be c o llecte d f or 9 0 da y s after d osi n g.
If a pre g na nc y is re p orte d, t he i n vesti gat or s h o ul d i nf or m t he s p o ns or wit hi n 2 4 h o urs of  lear ni n g 
of  t he pre g nanc y a n d s h o ul d f o ll ow t he pr oce d ures o utli ne d i n Sect i on  1 0. 4. 3 , A p pe n di x 4.
A b n or m al pre g na nc y o utc o mes, for e xa m ple, s p o nta ne o us a b orti o n, fetal deat h, still birt h, 
c o n ge nital a n o ma lies, a n d ect o pic pre g na nc y, are c o nsidere d S A Es.
8. 3. 6.
H y perse nsiti vit y R eacti o ns 
B i ol ogi c a ge nts carr y t he ris k of s yste mic h y perse nsiti vity reactio ns.
If s uc h a reacti on occ urs, a d diti o nal details descri bi n g eac h s y m pt o m s h o ul d be pr o vi de d t o t he 
s p o ns or i n t he i nf usi on- r elate d reactio n/ h y perse nsiti vit y C R F.
If s y m pt o ms a n d/ or si gns occ ur d uri n g or wi t hi n 6 h o urs after i nf usi on of L Y 3 8 1 9 2 5 3 a n d are 
belie ve d t o be h y perse nsit i vity or d ue t o c y t o ki ne release, t he n i n vest i gat ors are e nc o ura ge d t o 

C O N FI D E N TI A L
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re p ort t he e ve nt as i nf usi on- relate d i m me diate h y perse nsiti vity react i on or c y t o kine rel ease-
ass ociate d i nf usio n  reactio n, res pect i vel y.
Si tes s h o uld ha ve a p pr o pri atel y trai ne d me dical staff a n d a p pr o priate me dical e q ui p me nt 
a vaila ble w he n st u d y p artici pa nts are recei vi n g i nter ve nt i on. It is rec o m me n de d t hat partici pa nts 
w h o e x perie nce a s yst e mic h y perse nsit i vity react i on be treate d per t he l ocal sta n dar d of care.
I n t he case of ge neralize d urticaria or a na p h yla xis, a d diti onal bl o o d a n d uri ne sa m ples s h o ul d be 
c ollecte d as descri be d i n Secti o n  1 0. 6 , A p pe n di x 6, “Rec o m me n de d La b orat or y  Testi n g f or 
H y perse nsi tivi t y E ve nts”. La b orat or y res ults are pr o vi de d t o t he s p o ns or via t he ce ntral 
la b orat or y.
I n case of s ki n lesi ons or ras h c o nsiste nt wit h vasc ulit is, eff orts s h o ul d be ma de t o perf or m t he 
f oll owi n g as s o o n as p ossi ble

d er m at olo g y  c o ns ult atio n

s ki n bi o ps y, a n d

p h ot o gra p hs of lesi o ns of i nterest, i ncl u di n g s ki n bi o ps y site.
8. 3. 7.
I nf usi o n-rel ate d Re acti o ns
As wi t h ot her m A bs, i nf usi on- relate d reacti o ns ma y occ ur d uri n g or f o ll owi n g L Y 3 8 1 9 2 5 3 
a d mi nistrati o n.  If a n i nf usi on- r elate d reactio n occ urs, a d di tio nal data descri bi n g eac h s y m pt o m 
a n d si g n s h o ul d be pr o vi de d t o t he s p o ns or i n t he C R F.
T his ta ble descri bes t he l ocati o n of i nf usi o n- r elate d r eactio n i nf or m at i on i n t his pr ot oc ol.
T o pic
L oc ati o n
S pecial treat me nt c o nsi derati o ns
Secti o n  6. 1. 1
Pre me dicati o n f or i nf usi o ns
Secti o n  6. 1. 1. 1
Ma na ge me nt of i nf usi o n reacti o ns
Secti o n  6. 1. 1. 2
D AI D S ta ble descri bi n g se verit y
Sec ti o n 6. 1. 1. 2
Treat me nt g ui deli nes f or i nf usi o n -relate d reacti o ns 
Secti o n  6. 1. 1. 2
A b bre viati o n: D AI D S = Di visi o n of AI D S .
S y m pt o m s occ urri n g d uri n g or after i nf usi o n of st u d y  int er ve nt i on ma y als o be defi ne d acc or di n g 
t o A E cate g ories s uc h as ac ute aller gic reacti o n or c yt o ki ne release s y n dr o me ( D AI D S 2 0 1 7).
8. 3. 8.
Pr o d uct C o m pl ai nts
A pr o d uct c o m plai nt is a n y wri tte n, electr o nic, or oral c o m m u nicati on t hat alle ges deficie ncies 
r elate d t o t he i de ntit y,  q uality, d ura bilit y,  relia bility,  s afet y,  effecti ve ness or perf or ma nce of a 
trial int er ve nt i on.
S p o ns or c ollects pr o d uct c o m plai nts o n st u d y  int er ve nt i on a n d dr u g deli ver y s yste ms use d i n 
cli nical st u dies i n or der t o e ns ure t he safet y of  st u d y p artici pa nts, mo ni t or q ualit y, a n d t o 
facilitate pr ocess a n d pr o d uct i m pr o ve me nts.
P arti cipa nts or partici pa nt ’s le gal a ut h orize d re prese ntati ve will be i nstr ucte d t o c o ntact t he 
i n vesti gat or as s o o n as p ossi ble if t he y ha ve a c o m plai nt or pr o ble m wit h t he i nter ve nt i on s o t hat 
t he sit u atio n ca n be assesse d.

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N O T E: A E s/ S A Es t hat are ass ociate d wit h a pr o d uct c o m plai nt will als o f o ll ow t he pr ocesses 
o utli ne d i n Sect i on  8. 3. 3 a n d Secti o n 1 0. 3 , A p pe n di x 3, of  t he pr ot oc ol.
Ti me Peri o d f or Detecti n g Pr o d uct C o m pl ai nts
Pr o d uct c o m plai nts t hat res ult i n a n a d verse e ve nt will be detecte d, d oc u me nte d, a n d re p orte d t o 
t he s p o ns or d uri n g a ll peri o ds of t he st u d y in w hic h t he i nter ve nt i on is use d.
If t he i n vesti gat or lear ns of a n y pr o d uct c o m plai nt at a n y ti me after a partici pa nt has bee n 
di sc har ge d fr o m t he st u d y, a n d s uc h i nci de nt is c o nsi dere d reas o na bl y relate d t o a n i nter ve nt i on 
pr o vi de d f or t he st u d y , t he i n vesti gat or will pr om p tl y notif y  t he s p o ns or.
Pr o m pt Re p orti n g of Pr o d uct C o m pl ai nts t o S p o ns or
Pr o d uct c o m plai nts will be re p orte d t o t he s p o ns or wit hi n 2 4 h o urs after t he i n vest i gat or bec omes 
a ware of t he c o m p lai nt.
T he Pr o d uct C o m plai nt F or m will be se nt t o t he s p o ns or b y  a met h o d desig nate d b y  t he s p o ns or.
F oll o w -u p of Pr o d uct C o m pl ai nts
F o ll ow- u p a p plies t o all partici pa nts, i ncl u di n g t h ose w h o disc o nt i n ue st u d y int er ve nt i on.
T he i n vest i gat or is res p o nsi ble f or e ns uri n g t hat f oll o w-u p i ncl u des a n y s u p ple me ntal 
i n vesti gati ons as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of  t he pr o d uct c o m plai nt.
Ne w or u p date d i nf or mat i on will be rec or de d o n t he ori gi nall y c o m p lete d f or m with all c ha n ges 
sig ne d a n d da te d b y t he i n vesti gat or a n d s u b mitte d t o t he s p o ns or.
8. 4.
Tre at me nt of O ver d ose
T here i s n o k n o w n a nti d ote f or a n o ver d ose of L Y 3 8 1 9 2 5 3 al o ne or i n c o m bi nati on wi t h 
L Y 3 8 3 2 4 7 9 . 
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d
1.
c o ntact t he s p o ns or i m me diatel y.
2.
c l osel y mo ni t or t he partici pa nt f or a n y AE/ S A E a n d la b orat or y  a b n or malities 
3.
p r o vide s u p p orti ve care as necessar y , a n d
4.
d oc u m e nt t he q ua ntit y of t he e xcess d ose i n t he C R F.
Decisi o ns re gar di n g i nf usi o n i nterr u pti o ns or m o dificat i ons will be ma d e b y t he i n vest i gat or, i n 
c o ns ultati o n wit h t he s p o ns or, base d o n t he cli nical e val uat i on of t he partici pa nt.
8. 5.
P h ar m ac o ki netics
Ve n o us bl o o d sa mples will  be c ollecte d as s pecifie d i n t he S o A f or deter mi nati o n of 
c o nce ntrati o ns of L Y 3 8 1 9 2 5 3 a n d L Y 3 8 3 2 4 7 9 use d t o e val uate t he P K f or L Y 3 8 1 9 2 5 3 a n d 
L Y 3 8 3 2 4 7 9 .
A ma xi m u m of 3 sa m ples ma y be c ollecte d at a d diti o nal t i me p oi nts d uri n g t he st u d y if 
warra nte d a n d a gree d u p o n bet wee n t he i n vest i gat or a n d t he s p o ns or.
I nstr uctio ns f or t he c ollect i on a n d ha n dli n g of bi o lo gi cal sa m ples will be pr o vi de d b y Lill y. 

C O N FI D E N TI A L
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Si t e staff will rec or d

the date a n d ti me ( 2 4 -h o ur cl oc k ti me) of a d mi nistrati o n (start a n d e n d of i nf usi o n), a n d

the date a n d ti me ( 2 4 -h o ur cl oc k ti me) of eac h P K sa m ple.
It is esse ntial t hat t he ti mes are rec or de d acc uratel y.
8. 5. 1.
Bi o a n al ytic al
S a m ples will  be a nal yze d at a la b orat or y a p pr o ve d b y t he s p o ns or a n d st ore d at a facility 
desi g nate d b y  t he s p o ns or.  C o nce ntrati o ns of L Y 3 8 1 9 2 5 3 a n d L Y 3 8 3 2 4 7 9 will be assa ye d usi n g 
a vali date d bi oa nal ytical met h o d.  A nal yses of sa m ples c ollecte d fr o m place b o -treate d 
parti ci pa nts are n ot pla n ne d.
S a m ple rete nti o n is descri be d i n Sect i on  1 0. 1. 1 2 , A p pe n di x 1. Re m ai ni n g sa m ples use d f or P K 
ma y be p o ole d a n d use d f or e x pl orat or y  meta b o lism or bi oa nal y tical met h o d e x peri me nts as 
dee m e d a p pr o priate.
8. 6.
P h ar m ac o d y n a mics
T he S A R S -C o V -2 vi ral R N A le vel a nd viral  cleara nce will be e val uate d b y nas o p har y n geal 
a n d/or mi d -t ur bi nate, nasal, or or o p har y n geal s wa bs.  See Secti o n 1 0. 2 , A p pe n di x 2; a n d 
Secti o n 1. 3 , t he S o A, f or sa mple c ollecti o n i nf or mati o n.
S a m ple rete nti o n is descri be d i n Sect i on  1 0. 1. 1 2 , A p pe n di x 1.  Re m ai ni n g sa m ples ma y be use d 
f or a d ditio nal  e x plor at or y  st u dies t o better u n dersta n d L Y 3 8 1 9 2 5 3 alo n e a n d i n c o m bi nat i on wi t h
L Y 3 8 3 2 4 7 9 , a n d t he disease, w hic h ma y i ncl u de se q ue nci n g a n d/ or c ult ure of t he vir us f or f ut ure 
st u dies.
8. 7.
Ge netics
A w h o le bl o o d sa m ple will be c ollecte d f or p har mac o ge netic a nal ysis w here l ocal re g ulati ons 
all o w.
See Secti o n 1 0. 2 , A p pe n di x 2, a n d Sect i on  1. 3 , t he S o A, f or sa mple c ollecti o n i nf or mat i on.
See Secti o n 1 0. 5 , A p pe n di x 5, f or ge netic researc h , c ust o d y, a n d sa m ple rete ntio n i nf or mat i on.
8. 8.
Bi o m ar kers
Bl o o d sa m ples will be c ollecte d fr o m all part ici pa nts f or a nal ysis of i m m u ne s yste m-relate d 
mar kers. Ser u m, w h o le bl o o d f or cell ular a n d/ or e pi ge netic a nal ysis, a n d w h ole bl o o d R N A 
sa mples f or e x pl orat or y  bio m ar ker researc h will be c ollecte d at t he ti me s pecifie d i n t he S o A 
w here l ocal re g ulat i on s allo w.
S a mples will  be st ore d a n d a nal ysis ma y be perf or me d o n bi omar kers t h o u g ht t o pla y a r ole i n 
i m m u ne s yste m relate d res p o nses t o viral i nfecti on i ncl u di n g, b ut n ot li mite d t o , i m m u ne 
pat h wa ys, cell ular c o m p osit i on, ser u m a nal ytes, or e pi ge net ic bi omar kers, t o e valuate t hei r 
ass ociat i on wi t h o bser ve d cli nical res p o nses t o L Y 3 8 1 9 2 5 3 alo ne a n d i n c o m bi nat i on wi t h
L Y 3 8 3 2 4 7 9, a n d t he disease state .

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S a m ples ma y  be use d f or researc h t o de vel o p met h o ds, assa ys, pr o g n ostics a n d/ or c o m pa ni o n 
di a g n ostics r elate d t o t he i nter ve nti o n tar get ( S pr otei n), t he C O VI D -1 9 di sease state, pat h wa ys 
ass ociat e d wit h disease, a n d/ or t he mec ha nis m of  a ctio n of  t he st u d y int er ve nt i on.
S a m ple rete nti o n is descri be d i n Sect i on  1 0. 1. 1 2 , A p pe n di x 1.
8. 9.
I m m u n o ge nicit y Assess me nts
Visits a n d ti mes
A t t he visit s a n d ti mes s pecifie d i n t he S o A , ve n o us blo o d s a m ples will  be c ollecte d t o deter mi ne 
a nt i b o d y pr o d uctio n a gai nst L Y 3 8 1 9 2 5 3 a n d/ or L Y 3 8 3 2 4 7 9 .  T he act ual date a n d ti me ( 2 4-h o ur 
cloc k ti me) of eac h sa m ple c o llecti on will be rec or de d.
S a m ple c ollecti o n, h a n dli n g, a n d use
I nstr uctio ns f or t he c ollect i on a n d ha n dli n g of bl o o d sa m ples will be pr o vi de d b y t he s p o ns or.
I mm u n o ge nicit y ma y be assesse d b y a vali date d assa y  desi g ne d t o detect a nti dr u g a nt i b o dies 
(A D As ) i n t he prese nce of L Y 3 8 1 9 2 5 3 a n d/or L Y 3 8 3 2 4 7 9 at a lab orat or y  a p pr o ve d b y t he 
s p o ns or.  A nti b o dies ma y be f urt her c haracterize d f or t heir a bility t o ne utralize t he acti vity of  
L Y 3 8 1 9 2 5 3 a n d/ or L Y 3 8 3 2 4 7 9 .
S a m ple rete nti o n
S a m ple rete nti o n is descri be d i n Sect i on  1 0. 1. 1 2 , A p pe n di x 1.
8. 1 0.
He alt h Ec o n o mic s
T his sect i on is n ot a p plica ble f or t his st u d y.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
63
9.
Statistical Considerations
9.1.
Statistical Hypotheses
This study will compare LY3819253, alone and in combination with LY3832479, versus placebo 
in residents and facility staff of skilled nursing and assisted living facilities with a high risk of 
SARS-CoV-2 exposure. The primary study objective is to demonstrate superior efficacy of 
LY3819253 alone or in combination with LY3832479 over placebo in the prevention of COVID-
19.  Efficacy comparisons will be made without regard to changes to any background therapies.
A graphical testing sequence strategy will be used to adjust for multiplicity in the primary and 
key secondary endpoints within Part 1 and Part 2 of the study. All analyses on Part 3 are 
considered exploratory.
9.2.
Sample Size Determination
For Part 1, an estimated 33 events are needed to show superiority of LY3819253 4200 mg over 
placebo in each of the primary and key secondary endpoints, using the formula by Schoenfeld 
(1983). An average sample size of approximately 1300 participants who are SARS-CoV-2 PCR 
negative and serology negative at baseline is expected to obtain the needed number of events for 
each endpoint.
For Part 2, an estimated 56 events in the Prevention Cohort are needed to show superiority over 
placebo for either LY3819253 700 mg or LY3819253 350 mg+LY3832479 700 mg in each of 
the primary and key secondary endpoints. Approximately 2000 participants on average will be 
randomly assigned to study intervention such that approximately 1700 participants are 
randomized in the Prevention Cohort with the goal of achieving approximately 56 events on each 
of the primary and key secondary endpoints.
Due to the dynamic nature of the pandemic, Part 3 will enroll at least 30 participants and up to 
approximately 500 participants randomized to either LY3819253 700 mg or LY3819253 700 mg
+ LY3832479 1400 mg. Part 3 of the study is considered exploratory and is not powered for 
inference between the two treatment arms.
The maximum sample size for this study is approximately 5000 participants in the intent-to-treat 
(ITT) population.
Participants will be residents and staff of skilled nursing and assisted living facilities.  Globally,
there are many reports of the rapid spread of COVID-19 amongst residents of skilled nursing 
facilities following identification of an index case, with high associated rates of morbidity and 
mortality (Arons et al. 2020; Grabowski).  Given that residents at these facilities are at higher
risk for having a more severe disease course of COVID-19, this will be an important population 
to participate in the study.  Therefore, a minimum of 300 residents will be enrolled.  
Operationally, this will be accomplished, when possible, by identifying facilities where 
approximately half of the participants interested in the study are residents.
For sample size determination for Part 1, the following assumptions were used:
1) two-sided significance level of 0.05; 
2) 90% power for the primary and key secondary endpoints; 
3) an 8-week placebo group event rate of 4.0% for moderate or worse severity COVID-19; 

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4) a risk ratio of 0.33 between LY3819253 and placebo in terms of the primary and key 
secondary endpoints.
For sample size determination for Part 2, the following assumptions were used:
1) two-sided significance level of 0.025; 
2) 90% power for the primary and key secondary endpoints; 
3) an 8-week placebo group event rate of 5.3% for moderate or worse severity COVID-19; 
4) a risk ratio of 0.33 between active drug and placebo in terms of the primary and key 
secondary endpoints.
9.3.
Populations for Analyses
The following populations are defined:
Population
Description
Entered
All participants who provide informed consent.
Enrolled/ITT
All participants assigned to treatment, regardless of whether 
they take any doses of study treatment, or if they took the 
correct treatment.  Participants will be analyzed according to 
the treatment group to which they were assigned.
Facility Staff
All participants in the Enrolled/ITT population who are 
staff/employees of the facility. 
Residents
All participants in the Enrolled/ITT population who are 
residents of the facility.
Part 1 Safety
All participants randomly assigned to study intervention in 
Part 1 and who take at least 1 dose of study intervention. 
Participants will be analyzed according to the intervention they 
actually received.
Part 2 Safety
All participants randomly assigned to study intervention in 
Part 2 and who take at least 1 dose of study intervention. 
Participants will be analyzed according to the intervention they 
actually received.
Part 3 Safety
All participants randomly assigned to study intervention in 
Part 3 and who take at least 1 dose of study intervention. 
Participants will be analyzed according to the intervention they 
actually received.
Fully Dosed
All participants in the Safety population who receive a 
complete infusion of study intervention.
Part 1 Prevention
All participants in the Enrolled/Intent-to-Treat population in 
Part 1 who are SARS-CoV-2 RT-PCR negative and serology 
negative at baseline.

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Population
Description
Part 1 Treatment
All participants in the Enrolled/ITT population in Part 1 who 
are SARS-CoV-2 RT-PCR positive at baseline and serology 
negative. 
Part 2 Prevention
All participants in the Enrolled/Intent-to-Treat population in 
the Prevention Cohort in Part 2 who are SARS-CoV-2 POC 
and RT-PCR negative and serology negative at baseline.
Part 2 Treatment
All participants in the Enrolled/ITT population in the 
Treatment Cohort in Part 2 who are SARS-CoV-2 POC and 
RT-PCR positive and serology negative at baseline. 
Part 3 Treatment
All participants in the Enrolled/ITT population in Part 3 who 
are SARS-CoV-2 RT-PCR positive and serology negative at 
baseline.
Serology-Positive
All participants in the Enrolled/ITT population who are SARS-
CoV-2 serology positive at baseline.
POC-Positive/RT-PCR 
Negative
All participants in the Enrolled/ITT population in Part 2 who 
are SARS-CoV-2 POC positive and RT-PCR negative at 
baseline.
POC-Negative/RT-PCR 
Positive
All participants in the Enrolled/ITT population in Part 2 who 
are SARS-CoV-2 POC negative and RT-PCR positive at 
baseline.
PK Analysis
All randomized participants who received study intervention 
and have evaluable PK sample. Participants will be analyzed 
according to the intervention they received.
Abbreviations:  ITT = intent to treat; PK = pharmacokinetics; RT-PCR = reverse transcription – polymerase chain 
reaction; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Throughout the document, the term “the Prevention populations” will be used to describe both 
the Part 1 Prevention and Part 2 Prevention populations. Analyses on the Prevention populations 
will be conducted on each Prevention population separately. The terms “the Treatment 
populations” and “the Safety populations” are defined similarly.
The following study arms are defined for the purposes of comparison:
Study Arm
Study Part
Dose
Intervention
1
Part 1
4200 mg
LY3819253
2
Part 1
---
Placebo
3
Part 2 (Prevention Cohort)
700 mg
LY3819253
4
Part 2 (Prevention Cohort)
350 mg + 700 mg
LY3819253 + LY3832479
5
Part 2 (Prevention Cohort)
---
Placebo

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Study Arm
Study Part
Dose
Intervention
6
Part 2 (Treatment Cohort)
700 mg
LY3819253
7
Part 2 (Treatment Cohort)
700 mg + 1400 mg
LY3819253 + LY3832479
8
Part 3 
700 mg
LY3819253
9
Part 3
700 mg + 1400 mg
LY3819253 + LY3832479
9.4.
Statistical Analyses
Statistical analysis of this study will be the responsibility of Sponsor or its designee.
All tests of treatment effects will be conducted at a 2-sided alpha level of 0.05, unless otherwise 
stated, and all confidence intervals will be given at a 2-sided 95% level.
For subgroup analyses, all tests of interactions between treatment groups and other factors will 
be conducted at a 2-sided alpha level of 0.10.
Any change to the data analysis methods described in the protocol will require an amendment 
only if it changes a principal feature of the protocol.  Any other change to the data analysis 
methods described in the protocol, and the justification for making the change, will be described 
in the statistical analysis plan (SAP) and the clinical study report (CSR).  Additional exploratory 
analyses of the data will be conducted as deemed appropriate.
The statistical analysis plan will be finalized prior to un-blinding and it will include a more 
technical and detailed description of the statistical analyses described in this section. This section 
is a summary of the planned statistical analyses of the most important endpoints including 
primary and key secondary endpoints.
For analyses on the Part 2 Prevention population, LY3819253 700 mg and LY3819253 350 mg +
LY3832479 700 mg will be assessed against placebo separately. 
For analyses on the Part 3 Treatment population, results will be summarized separately for 
LY3819253 700 mg and LY3819253 700 mg + LY3832479 1400 mg. Part 3 is not powered for 
inference between the two treatment arms.
If enrolling to a placebo-controlled trial is challenged by an effective medication becoming 
available for prevention of COVID-19 and SARS-CoV-2, then the placebo arm may be dropped.
9.4.1. General Considerations
Baseline values for all measurements will be the last measurement taking prior to receiving study 
intervention, unless otherwise specified.
The primary analyses of the primary endpoints and key secondary endpoints will be based on 
events that occurred after randomization.
The analysis model for time-to-event analyses will be a Cox proportional hazards regression 
model for the time to the first occurrence of the relevant event, with treatment as a fixed effect.
For continuous measures, analysis of covariance (ANCOVA) and/or mixed-effects model for 
repeated measures (MMRM) will be used to analyze changes from baseline with the baseline 

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value as the covariate.  The MMRM model will include fixed effects for treatment, visit, 
treatment-by-visit interaction, the baseline as a covariate and the participant as a random effect.  
Summary statistics will include sample size, mean, standard deviation, median, 10th and 90th
percentiles for both the actual and the change from baseline measurements.  Least-squares mean 
(LS mean) and standard error derived from the model will also be displayed for the change from 
baseline measurement.  Treatment comparisons will be displayed showing the treatment 
difference LS Mean and the 95% confidence limits along with the p-value.
For continuous lab measurements, an analysis of variance (ANOVA) on ranks will be used and 
p-values for the difference between each study intervention and placebo will be reported.
For categorical measures, summary statistics will include sample size, frequency, and 
percentage.  For primary and secondary analyses, a logistic regression model will be used. The 
model will include fixed effects for treatment and stratification factors such as facility. For other 
analyses, frequencies will be analyzed using Chi-square tests if the expected count is at least 5, in 
at least 80% of the cells, otherwise a Fisher’s exact Test will be used.
All analyses will be implemented using SAS® Version 9.4 or higher, or R version 3.6.3 or 
higher.
9.4.2.
Participant Disposition
A listing of participant discontinuation will be presented for all randomized participants.  
Summary analyses will be conducted for the Prevention, Treatment, and Safety populations.
Frequency counts and percentages will be presented for each treatment group and compared 
across treatment groups using Chi-square tests or Fisher’s exact tests.
9.4.3.
Participant Characteristics
Demographic and baseline characteristics will be summarized by treatment group for the 
Prevention, Treatment, and Safety populations.  For continuous measures, summary statistics 
will include sample size, mean, median, 10th and 90th percentiles and standard deviations.  Means 
will be analyzed using ANOVA.  For categorical measures, summary statistics will include 
sample size, frequency, and percentages.
9.4.4.
Concomitant Therapy
Concomitant medications will be summarized by classes of medications and by treatment group 
using the ITT population. Frequencies will be analyzed using Chi-square tests or Fisher’s exact 
tests.
9.4.5.
Primary Endpoint
The endpoint for the primary analysis in the prevention populations is defined as cumulative
incidence of COVID-19, defined as the detection of SARS-CoV-2 by RT-PCR AND mild or 
worse disease severity within 21 days of detection, up to 8 weeks after randomization.
The primary analysis model will be a logistic regression model which will include occurrence of 
a primary endpoint event as the response variable, and treatment and stratification factors such as 
facility as explanatory variables.

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9.4.6.
Secondary Endpoints
As key secondary analyses, the proportion of participants who experience each of the following 
will be assessed on the Prevention population:

Cumulative incidence of moderate or worse severity COVID-19 (within 8 weeks from 
randomization)

Cumulative incidence of SARS-CoV-2 infection (within 4 weeks from randomization)
The analysis model for the key secondary analyses will be similar to the primary analysis model.
To control for multiplicity, a fixed-sequence approach will be used to test the primary and key 
secondary endpoints. A separate testing sequence will be used for each part of the study. The 
final testing sequences will be specified in the SAP.
Additionally, the following secondary analyses will be conducted on the Prevention population:

The proportion of participants who experience each of the following will be compared 
across treatments:
o
Cumulative incidence of SARS-CoV-2 infection, up to 8 weeks from 
randomization
o
Hospitalization or death due to COVID-19, up to 8 weeks from randomization
o
Hospitalization due to COVID-19, COVID-19 related emergency visit, or death
o
Death due to COVID-19, up to 8 weeks from randomization
9.4.6.1.
Safety Analyses
Unless otherwise noted, all safety analyses will be conducted on the Safety population.
All AEs will be listed by participant and may include information on treatment group, visit, 
preferred term, severity, seriousness, and relationship to the study medication, procedure, or 
device.
Treatment-emergent adverse events (TEAEs) will be defined as events that first occur or worsen 
(increase in severity) after the first injection of study drug following randomization.  The count 
and proportion of participant with TEAEs will be summarized for each treatment group.  Overall 
treatment group differences will be compared using Chi-square tests or Fisher’s exact tests.
Serious adverse events will also be summarized.  The counts and proportion of participants
experiencing the event of interest will be reported for each treatment arm.  Treatment groups will 
be compared by Chi-square tests or Fisher’s exact tests.
Permanent discontinuations of study drug due to AEs will be listed.  The count and proportion of 
discontinuations of study drug due to AEs will be reported.  Time to discontinuation (due to 
AEs) will be compared between treatment groups using a Cox proportional hazard regression 
model with treatment as a fixed effect.  Kaplan-Meier curves for both treatment groups will be
reported.
9.4.6.2.
Pharmacokinetic Analyses
Pharmacokinetic analyses will be conducted on data from all participants who receive 
intervention and have evaluable PK.  Pharmacokinetic estimates for LY3819253 and LY3832479 

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ma y be s u m marize d b y sa m ple ti me, s uc h as, o n Da y  2 9. A p o p ulat i on a p pr oac h usi n g a 
n o nli near mi xe d -effects mo deli n g ( N O N M E M) pr o gra m ma y als o be perf or me d.
St u d y data ma y be p o ole d wit h t he res ults of ot her st u dies f or p o p ulat i on P K a n d P K/ P D a nal ysis 
p ur p oses.
9. 4. 7.
E x pl or at or y E n d p oi nts
As e x pl orat or y a nal yses, t he pri mar y a n d sec o n dar y a nal yses ma y be re peate d o n t he Treat me nt 
p o p ul at i ons a n d o n all partici pa nts w h o are i n eit her t he Pre ve nti o n or Treat me nt p o p ulat i ons i n 
Part 1 a n d 2 .
A d dit i onal e x plor at or y  a nal yses f or Part 1 a n d Part 2 ma y i ncl u de

ti me t o i m pr o ve me nt of  C O VI D -1 9 disease t o mil d se verity,  in t he s u bset of t he 
parti ci pa nts w h o ha ve at baseli ne, or de vel o p , m o derate or w orse C O VI D - 1 9

w orst sc ore acc or di n g t o NI AI D or di nal scale(s)

e xa mi nat i on of vir o l og y  for parti ci pa nts w h o bec o me S A R S -C o V -2 p osit i ve,

e xa mi nat i on of viral resista nce t o eac h st u d y int er ve nt i on,

d urati o n of  h os pit ali z atio n i n parti ci pa nts w h o are h os pitalize d d ue t o C O VI D - 1 9, a n d

s u b gr o u p a nal yses of pri mar y a n d k e y  sec o n dar y e n d p oi nts wit hi n resi de nts vers us staff.
F or Part 3 , e x plorat or y  a nal yses are liste d i n Secti o n  3.
A d dit i onal e x plor at or y  a nal yses o n Part 3 ma y be c o n d ucte d.
Details o n t hese a nal yses will be descri be d i n t he S A P.
9. 4. 8.
Ot her S afet y A n al yses
Ot her safety a nal yses will i ncl u de vital si g ns a n d la b orat or y  a nal yt es. Cate g orical safet y 
meas ures will be s u m marize d wit h c o u nts a n d pr o p ortio ns of  partici pa nts, a n d c o m pare d b y 
treat me nt usi n g eit her a C hi-s q uare test or a Fis her’s e xact test. C o nti n u o us safet y me as ures will 
be s u m marize d as mea n c ha n ge b y visit a n d will be a nal yze d usi n g a n M M R M m o del wit h 
treat me nt i ncl u de d as a n e x pla nat or y varia ble. E x p os ure t o st u d y i nter ve nt i on will be calc ulate d 
f or eac h partici pa nt a n d s u m marize d b y tr e at me nt gr o u p.
9. 4. 9.
I m m u n o ge nicit y A n al yses
If data fr om vali date d i m m u n o ge nicit y assa ys are a vaila ble, treat me nt -e mer ge nt a ntidr u g 
a nt i b o dies (T E -A D As ) ma y be assesse d.
Treat me nt -e mer ge nt A D As are defi ne d as partici pa nt s

wi t h a 2-f ol d ( 1 dil uti o n) i ncrease i n titer t ha n t he mi ni m u m re q uire d dil ut i on if n o A D As 
were detecte d at baseli ne (treat me nt -i n d uce d A D A) or

wi t h a 4-f ol d ( 2 dil uti o ns) i ncrease i n titer c o m pare d wit h baseli ne if A D As were detecte d 
at baseli ne (treat me nt -b o oste d A D A).
T he fre q ue nc y a n d perce nta ge of partici pa nts wit h pree xist i n g A D A a n d w h o are T E -A D A 
p osi tive ( T E -A D A +) t o eac h st u d y int er ve nt i on will be ta b ulate d.

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T he distri b ut i on of titers a n d fre q ue nc y o f ne utralizi n g a nti b o dies (if assesse d) f or t h e T E -A D A + 
parti ci pa nt s ma y als o be ta b ulate d.
T he rel at i ons hi p bet wee n t he prese nce of a nt i b o dies a n d P K para meters, efficac y res p o nse or 
safety t o eac h st u d y int er ve nt i on ma y als o be assesse d.  A d dit i onal details ma y  be pr o vide d i n 
t he S A P.
9. 5.
I nteri m A n al yses 
M o ni t ori n g of u n bli n de d safety data (i ncl u di n g A Es, S A Es, a n d selecte d la b orat or y  
meas ure me nts) will occ ur t hr o u g h o ut t he st u d y  a n d will be c o n d ucte d b y a n e xter nal D S M B. 
T he D S M B will ma ke rec o m me n dati o ns c o ncer ni n g t he c o n d uct of t he st u dies, i ncl u d i n g 
c ha n ges t o t he i nf or me d c o nse nt f or m.
O nl y t he D S M B is a ut h orize d t o e val uate u n bli n de d i nteri m efficac y a n d safety a nal yses.  St u d y 
sites will recei ve i nf or mati o n a b o ut i nteri m res ults o nl y if t he y nee d t o k n o w f or t he safety of  
t heir p artici pa nts.
U n bli n di n g details are s pecifie d i n t he u n bli n di n g pla n sect i on of t he S A P or i n a se parate 
u n bli n di n g pla n d oc u me nt.
T he S A P a n d D S M B c harter will descri be t he pla n ne d i nteri m a nal yses , i ncl u di n g ti mi n g of a n y 
i nteri m a nal yses, i n greater detail.
9. 6.
D at a M o n it ori n g C o m mittee ( D M C)
T he s p o ns or will f or m a D S M B t o a nal yze t he i nteri m st u d y  data. T o mi ni mize a n y bias 
i ntr o d uce d i nt o t he a nal ysis of t he st u d y res ults, a nal ysis pla ns will be fi nalize d a n d a p pr o ve d 
pri or t o t he i nteri m a nal yses.
T he pri mar y  g o al of t he D S M B is t o re vie w t he i nteri m res ults re gar di n g t he c o nti n ui n g safet y of 
st u d y partici pa nts a n d t he c o nti n ui n g vali dity a n d scie nt ific merit of t he st u d y. I nf or mat i on t hat 
ma y u n bli n d t he st u d y  d uri n g t he a nal yses will n ot be re p orte d t o st u d y sit es or t he bli n de d st u d y  
tea m u ntil t he st u d y has bee n u n bli n de d. 
O verall c o m mittee str uct ure i nf or mati o n is i n Sect i o n 1 0. 1. 5 , A p pe n di x 1 . Details of t he D S M B 
will be pr o vi de d i n t he D S M B c harter.

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10.
Supporting Documentation and Operational Considerations
10.1.
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations
10.1.1.
Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines

Applicable International Council for Harmonisation Good Clinical Practice (GCP) 
Guidelines

Applicable laws and regulations
The protocol, protocol amendments, ICF, IB, and other relevant documents (e.g., advertisements) 
must be submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC 
before the study is initiated.
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC

Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures

Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 for clinical 
studies (if applicable), and all other applicable local regulations
Investigator sites are compensated for participation in the study as detailed in the clinical trial 
agreement. Facility sites are compensated for the use of the grounds and building as outlined in 
the approved agreement.
10.1.2.
Financial Disclosure
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the study and for 1 year after 
completion of the study.

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10.1.3.
Informed Consent Process
The investigator or their representative will explain the nature of the study, including the risks 
and benefits, to the participant or their legally authorized representative and answer all questions 
regarding the study.
Participants must be informed that their participation is voluntary.  Participants or their legally 
authorized representative will be required to sign a statement of informed consent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act requirements, where applicable, and the IRB/IEC or study center.
Due to strict respiratory isolation policies, limited access to COVID-19 participants rooms, and 
SARS-CoV-2 transmissibility via droplet-contaminated paper, verbal consent and alternative 
methods of obtaining consent (for example, by phone) will be allowed if approved by the IRB.  
This includes obtaining the appropriate signatures and dates on the ICF prior to the performance 
of any protocol procedures and prior to the administration of investigational product.
Any variation from the standard consent process due to isolation and infection control should be 
sent to the IRB for approval prior to enrollment. The site will document the process in their 
regulatory files and demonstrate that the process has IRB concurrence or approval.
The participant record must document how consent was obtained before the participant was 
entered in the study and the date the written consent was obtained.  The authorized person 
obtaining the informed consent and, if applicable, the individual designated to witness a verbal 
consent, must use the appropriate measure (that is, electronic, written) to provide signature and 
date.
Participants must be re-consented to the most current version of the ICF(s) during their 
participation in the study.
A copy of the ICF(s) must be provided to the participant or the participant’s legally authorized 
representative and is kept on file.
10.1.4.
Data Protection
Participants will be assigned a unique identifier by the sponsor. Any participant records, datasets 
or tissue samples that are transferred to the sponsor will contain the identifier only; participant 
names or any information which would make the participant identifiable will not be transferred.
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law.  The level of disclosure must also be 
explained to the participant who will be required to give consent for their data to be used as 
described in the informed consent.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
The sponsor has processes in place to ensure data protection, information security and data 
integrity.  These processes include appropriate contingency plan(s) for appropriate and timely 
response in the event of a data security breach.

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10.1.5.
Committees Structure
The DSMB will consist of members external to Lilly.  DSMB membership will include, at a 
minimum, a statistician and two physicians with expertise in the appropriate specialties. Details 
about the DSMB membership, purpose, responsibilities, and operation will be described in a 
DSMB charter.
10.1.6.
Dissemination of Clinical Study Data
A clinical study report will be provided for this study and a summary of study information 
provided on publicly available websites. 
10.1.7.
Data Quality Assurance
Investigator Responsibilities
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (e.g., laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or electronically 
signing the CRF.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents.
Data Monitoring and Management
The Monitoring Plan includes

monitoring details describing strategy, for example, risk-based initiatives in operations 
and quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring

methods

responsibilities and requirements

handling of noncompliance issues and

monitoring techniques.
The sponsor or designee is responsible for the data management of this study including quality 
checking of the data.  The sponsor assumes accountability for actions delegated to other 
individuals (e.g., Contract Research Organizations).
Study monitors will perform ongoing source data verification to confirm that data entered into 
the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents.  They will also ensure that the safety and rights of participants are being protected; 
and that the study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements.
If on-site monitoring activities cannot occur, alternative measures will be used.  Examples of 
alternative measures are use of technology for off-site monitoring or providing pseudonymized 

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copies of source documents to the monitor electronically.  The remote source data verification 
will be focused on critical efficacy data and important safety data.
Records Retention and Audits
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for the time period outlined in the Clinical Trial Agreement (CTA) 
unless local regulations or institutional policies require a longer retention period.
No records may be destroyed during the retention period without the written approval of the 
sponsor. No records may be transferred to another location or party without written notification 
to the sponsor.
The sponsor or its representatives will periodically check a sample of the participant data 
recorded against source documents at the study site.  The study may be audited by Sponsor or its 
representatives, and/or regulatory agencies at any time.  Investigators will be given notice before 
an audit occurs.
Data Capture System
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported to the sponsor.
An electronic data capture system (EDC) will be used in this study for the collection of CRF 
data.  The investigator maintains a separate source for the data entered by the investigator or 
designee into the sponsor-provided EDC system, except for vital signs and symptom assessment.  
Vital signs and symptom assessments will be direct data captured in the EDC system, and will 
serve as the source documentation.  The investigator does not maintain a separate written or 
electronic record of these data.  If there are clinical or business continuity needs that do not 
enable these data to be direct data captured, these data will be captured as source via paper and 
transcribed into EDC.  The investigator is responsible for the identification of any data to be 
considered source and for the confirmation that data reported are accurate and complete by 
signing the CRF.
Data collected via the sponsor-provided data capture systems will be stored at third-parties. The 
investigator will have continuous access to the data during the study and until decommissioning 
of the data capture systems.  Prior to decommissioning, the investigator will receive an archival 
copy of pertinent data for retention.
Data managed by a central vendor, such as laboratory test data, will be stored electronically in 
the central vendor’s database system and results will be provided to the investigator for review 
and retention.  Data will subsequently be transferred from the central vendor to the Sponsor data 
warehouse.
Data from complaint forms submitted to Sponsor will be encoded and stored in the global 
product complaint management system.
10.1.8.
Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed by the investigator’s site.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
7 5
Data re p orte d o n t he C R F t hat are tra nscri be d fr o m s o urce d oc u me nts m ust be c o nsiste nt wit h 
t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d. T he i n vest i gat or ma y nee d t o 
re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g o n t he st u d y.
D ef i niti on o f w hat c o nstit utes s o urce data ca n be f o u n d i n  1 0. 1. 7 .
1 0. 1. 9.
St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date o n w hic h t he cli nical st u d y will be o pe n f or recr uitme nt  of 
parti ci pa nts.
Site Cl os ure
T he s p o ns or desi g nee reser ves t he ri g ht t o cl ose t he st u d y  site or ter mi nate t he st u d y at a n y ti me 
f or a n y reas o n at t he s ole discret i on of t he s p o ns or. St u d y  sites will b e close d u p o n st u d y 
c o mplet i on. A st u d y  site is c o nsi dere d close d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies 
ha ve bee n c o llecte d a n d a st u d y-sit e clos ure visi t has bee n perf or me d.
T he i n vest i gat or ma y i nitiate st u d y-sit e clos ure at a n y  time, pr o vi de d t he r e is reas o na ble ca use 
a n d s ufficie nt n otice is gi ve n i n a d va nce of t he i nte n de d ter mi nat i on.
Reas o ns f or t he earl y cl os ure of a st u d y  site b y t he s p o ns or or i n vesti gat or ma y incl u de b ut are 
n ot li mite d t o:

Fail ure of t he i n vest i gat or t o c o m pl y with t he pr ot oc ol , t he re q uire me nts of t he I R B/I E C 
or l o c al  healt h a ut h orities, t he s p o ns or's pr oce d ures, or G C P g ui deli nes

I na de q uate recr uitme nt  of p artici pa nts b y t he i n vestigat or

Di sc o nti n uatio n of  furt her st u d y  int er ve nt i on de vel o p m e nt
If t he st u d y is pre mat urel y t er mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
I n vesti gat ors, t he I E Cs/I R Bs, t he re g ulat or y a ut h orities, a n d a n y c o ntract researc h 
or ga ni zat i on(s) use d i n t he st u d y  of t he reas o n f or ter mi nati on or s us pe nsi o n, as s pecifie d b y t he 
a p plica ble re gulat or y  r e q uire me nts. T he I n vesti gat or s hall pr om ptl y i nf or m t he partici pa nt a n d 
ass ures a p pr o priate partici pa nt t hera p y a n d/ or f oll ow- u p.
1 0. 1. 1 0.
P u blic ati o n P olic y
I n acc or da nce wit h t he s p o ns or’s p u blicati o n p olic y t he res ults of t his st u d y will be s u b mitte d f or 
p u blicat i on b y a peer -re vie we d j o ur nal.
1 0. 1. 1 1.
I n vesti g at or I nf or m ati o n
Lice nse d p h ysicia ns wi t h a s pecialty i n i nter nal me dici ne, ger o nt olo g y , i nfecti o us disease, 
critical care, or p ul mo n ar y  disease or ot her s peci alt y dee me d t o be a p pr o priate b y t he s p o ns or 
ma y parti ci pate as i n vesti gat ors.
1 0. 1. 1 2.
L o n g -Ter m S a m ple Rete nti o n
S a m ple rete nti o n e na bles use of ne w tec h n o l ogi es, res p o nse t o re g ulat or y q uesti ons, a n d 
i n vesti gati on of varia ble res p o nse t hat ma y n ot be o bser ve d u nt il later i n t he de vel o p me nt of t he 
i nter ve nt i on or after  t he i nter ve nti on  bec o me s c o m merciall y a vaila ble.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
76
This table describes the retention period for potential sample types.
Sample Type
Custodian
Retention Period After Last Patient Visit
Pharmacodynamic Samples
Sponsor or designee
up to 7 years
Pharmacogenetics sample
Sponsor or designee
up to 7 years
Exploratory Biomarker Samples
Sponsor or designee
up to 7 years
Immunogenicity (ADA) sample
Sponsor or designee
up to 7 years
Pharmacokinetic sample
Sponsor or designee
up to 2 years
Abbreviation: ADA = antidrug antibody.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
7 7
1 0. 2.  
A p pe n di x 2: Cli nic al L a b or at or y Tests
Cli nical la b orat or y  tests will b e p erfor m e d acc or di n g t o t he S o A.  
A d dit i onal tests ma y be perf or me d at a n y  time d uri n g t he st u d y  as deter mi ne d necessar y b y t he 
i n vesti gat or or re q uire d b y l ocal re g ulati ons.
Ce ntral  a n d lo c al  la b orat ories will be use d. T he S o A a n d ta ble belo w descri bes w he n t he l ocal or 
ce ntral la b orat or y will be use d.
La b orat or y  res ults t hat c o uld u n bli n d t he st u d y  will not be re p orte d t o i n vest i gati ve sites or ot her 
bli n de d pers o n nel.
Pr ot oc ol -s pecific re q uire me nts f or i ncl usi o n or e xcl usi o n of partici pa nts are detaile d i n Sect i on  5
of  t he pr ot oc ol.
Pre g na nc y testi n g will be perf or me d acc or di n g t o t he S o A.
I n vesti gat ors m ust d oc u me nt t heir re vie w of la b orat or y safet y res ults.
Refer t o Secti o n  1 0. 6 , A p pe n di x 6, f or rec o m me n de d la b orat or y testi n g f or h yperse nsi tivi t y 
e ve nts.

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
78
Clinical Laboratory Tests
Comments  
Hematology
Assayed by Lilly-designated laboratory
Hemoglobin
Hematocrit
Erythrocyte count (Red Blood Cells - RBCs)
Mean cell volume 
Mean cell hemoglobin
Leukocytes (White Blood Cells - WBCs) 
Differential
   Neutrophils, segmented
   Lymphocytes
   Monocytes
   Eosinophils
   Basophils
Platelets
Cell Morphology (RBC and WBC)
Clinical Chemistry
Assayed by Lilly-designated laboratory
Sodium
Potassium
Chloride
Bicarbonate
Total bilirubin
Direct bilirubin
Alkaline phosphatase (ALP)
Alanine aminotransferase (ALT)
Aspartate aminotransferase (AST)
Gamma-glutamyl transferase (GGT)
Blood urea nitrogen (BUN)
Creatinine 
Creatine kinase (CK)
Uric acid
Total protein
Albumin
Calcium
Phosphorus
Glucose
Amylase
Lipase
Lactate dehydrogenase (LDH)

CONFIDENTIAL
J2X-MC-PYAD(d); CoVPN #3501
79
Clinical Laboratory Tests
Comments  
Calculations
eGFR 
calculated by CKD-EPI equation.
Calculated by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
SARS-Cov-2 Panel
C-Reactive Protein
Ferritin
D-dimer
Procalcitonin 
Troponin 
Hormones (female)
Urine Pregnancy
Local laboratory
Pharmacokinetic Samples  
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Pharmacodynamic sample
Assayed by Lilly-designated laboratory. 
   SARS-Cov-2 swab (nasopharyngeal, mid-
turbinate, nasal, or oropharyngeal)
Negative results will not be provided to the investigative sites.
SARS-Cov-2 Serology
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Pharmacogenetics sample
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Exploratory Biomarker Samples 
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Serum
   RNA (PAXGene)
   Whole Blood (EDTA) Epigenetics
Immunogenicity (ADA) Samples
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
   Anti-LY3819253 antibodies
  Anti-LY3832479 antibodies

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 0
1 0. 3.
A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or 
Rec or di n g, E v al u ati n g, F oll o w -u p, a n d Re p orti n g
1 0. 3. 1.
Defi niti o n of A E
A E Defi niti o n

A n A E i s a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y p artici pa nt, 
t e mp orall y  ass o ciat e d wit h t he use of st u d y int er ve nt i on, w het her or n ot c o nsi dere d 
r elate d t o t he st u d y int er ve nt i on.

N O T E: A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or e xacer bate d) te m p orall y 
ass ociat e d wit h t he use of st u d y int er ve nt i on.
E ve nts Meeti n g
t he A E Defi niti o n

A n y a b n or mal la b orat or y  test res ults ( he mat olo g y , cli nical che mistr y , or urinal ysis) or 
ot her safet y assess me nts (e. g., electr ocar di o gra m, ra diol o gi cal sca ns, vital si g ns 
meas ure me nts), i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y 
sig nifica nt i n t he me dical a n d scie ntific j u d g me nt of t he i n vesti gat or (i .e., n ot relate d t o 
pr o gressi o n of u n derl yi n g disease).

E xacer bat i on of a c hr o nic or i nter mitte nt pre -e xist i n g c o n diti on i ncl u di n g eit her a n 
i ncrease i n fre q ue nc y a n d/ or i nte nsity of  t he c o n ditio n .

Ne w c o n dit i ons detecte d or dia g n ose d after st u d y  i nter ve nti on a d mi nistrati o n e ve n 
t ho u g h it m a y ha ve bee n prese nt bef ore t he start of t he st u d y.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y 
i nter ve nt i on or a c o nc o mita nt me dicat i on. O ver d ose per se will n ot be re p orte d as a n 
A E/ S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p ossi ble s uici dal/self -har mi n g 
i nte nt. S uc h o ver d ose s h o ul d be re p orte d re gar dless of se q uelae. 

“ Lac k of efficac y” or “fail ure of e x pecte d p har mac ol o gical act i on” per se will n ot be 
re p orte d as a n A E or S A E. S uc h i nsta nces will be ca pt ure d i n t he efficac y assess me nts. 
H o we ver, t he si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ult i n g fr om lac k of efficac y 
will be re p or te d as A E or S A E if t he y f ulfill t he defi niti on of a n A E or S A E. 
E ve nts N O T Meeti n g t he A E Defi niti o n

T he f o ll owi n g st u d y -s pecific cli nical e ve nts relate d t o C O VI D-1 9 are e xe m pt fr o m 
a d verse e ve nt re p orti n g u nless t he i n vest i gat or dee ms t he e ve nt t o be relate d t o t he 
a d mi nistrati o n of st u d y dr u g:
o
H y p o xe mia d ue t o C O VI D -1 9 re q uiri n g s u p ple me ntal o x y ge n;
o
H y p o xe mia d ue t o C O VI D -1 9 re q uiri n g n o n -i n vasi ve ve ntilati o n or hi g h fl o w 
o x y ge n de vices;

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 1
o
Res pirat or y  fail ure d ue t o C O VI D -1 9 re q uiri n g i n vasi ve mec ha nic al ve ntilati on 
or E C M O

A n y cli nicall y  sig nifica nt a b n or mal la b orat or y  fi n di n gs or ot her a b n or mal safety 
assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c on dit i on.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o m s of t he 
di sease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he partici pa nt’s 
c o n ditio n.

Me dical or s ur gical pr oce d ure (e. g., e n d osc o p y , a p pe n dect o m y): t he c o n ditio n t hat 
lea ds t o t he pr oce d ure is t he A E.

Si t u atio ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A nt ici pate d da y-t o-da y fl uct uati o ns of pre-e xist i n g disease(s) or c o n diti on(s) prese n t or 
detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
1 0. 3. 2.
Defi niti o n of S A E
If a n e ve nt is n ot a n A E per defi niti on a b o ve, t he n it ca n n ot be a n S A E e ve n if seri o us c o n dit i ons 
are met (e. g., h os pitalizat i on f or sig ns/s y m pt o ms of t he disease u n der st u d y , deat h d ue t o 
pr o gressi o n of disease).
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose:
a.
Res ults i n de at h
b.
Is i m me di atel y life-t hre ate ni n g
T he ter m  “life-t hreate ni n g” i n t he defi niti on of “s erio us ” refers t o a n e ve nt i n w hic h t he 
parti ci pa nt was at ris k of deat h at t he ti me of t he e ve nt. It d oes n ot refer t o a n e ve nt, w hic h 
h y p ot heti call y mi g ht ha ve ca use d deat h, if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n

I n ge neral, h os pitalizati on si g nifies t hat t he partici pa nt has bee n a d mitte d t o h os pital 
f or o bser vati on a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h ysicia n’s office or o ut patie nt setti n g. C o m plicat i o ns t hat occ ur d uri n g h os pi talizatio n 
are A Es. If a c o m plicat i on pr ol o n gs h os pi talizatio n or f ulfills a n y  ot her serio us cri t eria, 
t he e ve nt is seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was 
necessar y , t he A E s h o uld be c o nsi dere d seri o us.

H os pitalizati o n f or elect i ve treat me nt of a pre-e xisti n g c o n dit i on t hat di d n ot w orse n 
fr om baseli ne is n ot c o nsi dere d a n A E.
d.
Res ults i n persiste nt dis a bilit y/i nc a p acit y

T he ter m disa bili t y mea ns a s u bsta nt ial disr u pt i on of a pers o n’s a bilit y t o c o n d uct 
n or m al life f unct i ons.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 2

T his defi nit i on is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or me dical 
sig nifica nce s uc h as u nc o m p licate d hea dac he, na usea, v o miti n g, diarr hea, i nfl ue nza, 
a n d acci de ntal tra u ma (e. g., s prai ne d a n kle) w hic h ma y i nterfere wit h or pre ve nt  
e ver y da y life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pt i on.
e.
Is a c o n ge nit al a n o m al y/ birt h defect
f.
Ot her sit u ati o ns:

Me dical or scie nt ific j u d g me nt s h o ul d be e xercise d i n deci di n g w het her S A E re p orti n g 
is a p pr o priate i n ot her sit uati o ns s uc h as i m p orta nt me dical e ve nts t hat ma y n ot be 
i m me diatel y life-t hreate ni n g or res ult i n deat h or h os pitalizati o n b ut ma y je o par dize t he 
parti ci pa nt or ma y re q uir e me dical or s ur gical i nter ve nt i on t o pre ve nt o ne of t he ot her 
o utc o m es liste d i n t he a b o ve defini tio n . T hese e ve nts s h o ul d us uall y be c o nsi dere d 
serio us.

E xa m ples of s uc h e ve nts i ncl u de i nte nsi ve treat me nt i n a n e mer ge nc y  r o o m or at h o me 
f or aller gic br o nc h os pas m, bl o o d d yscrasias or c o n v ulsi ons t hat d o n ot res ult i n 
h os pi talizatio n, or de vel o p m e nt of  dr u g de pe n de nc y or dr u g a b use.
1 0. 3. 3.
Rec or di n g a n d F oll o w -U p of A E a n d/ or S A E
A E a n d S A E Rec or di n g

W he n a n A E/ S A E occ urs, it is t he res p o nsi bilit y of t he i n vesti gat or t o re vie w all 
d oc u m e nt atio n (e. g., h os pi t al pr o gress n otes, la b orat or y re p orts, a n d di a g n ostics 
re p orts) relate d t o t he e ve nt.

T he i n vest i gat or will t he n rec or d all rele va nt A E/ S A E i nf or mati on i n t he C R F.

It is n ot acce pta ble f or t he i n vest i gat or t o se n d p h ot oc o pies of t he partici pa nt’s me dical 
rec or ds t o S p o ns or or desi g nee i n lie u of c om p leti on of t he A E/ S A E C R F pa ge.

T here m a y be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d 
b y S p o ns or or desi g nee. I n t his case, all part ici pa nt i de ntifiers, wit h t he e xce pti o n of 
t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical rec or ds bef ore 
s u b missi on t o S p o ns or or desi g nee.

T he i n vest i gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s y m pt o ms, a n d/ or ot her cli nical i nf or mati on. W he ne ver p ossi ble, t he dia g n osis ( n ot t he 
i n di vi d ual sig ns/s y m pt o m s) will be d oc u me nte d as t he A E/ S A E.
Assess me nt of I nte nsit y
T he i n vest i gat or will ma ke a n assess me nt of i nte nsity f or eac h n o n- i nf usi on- r elate d A E a n d 
S A E re p orte d d uri n g t he st u d y  a n d assi g n it t o o ne of t he f oll owi n g cate g ori es, w hic h t o get her 
wi t h serio us (i .e., S A E) crit eria o n t he A E C R F (“res ults i n deat h” a n d “life -t hreate ni n g”), are 
ali g ne d wit h t he D AI D S T a ble f or Gr a di n g t he Severity of A d ult a n d Pe di atric A dverse 
Eve nts, C orrecte d Versi o n 2. 1 ( J uly 2 0 1 7) .

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 3
Mil d:
Mil d s y m pt o ms ca usi n g n o or mi ni mal i nterfere nce wit h us ual s ocial a n d f u ncti o nal 
acti vit ies, wit h i nter ve nti o n n ot i n dicate d.
M o der ate:
M o derate s y m pt o ms ca usi n g greater t ha n mi n i mal i nterfere nce with us ual 
s o cial a n d fu n cti o n al  acti vities, wit h i nter ve nti o n i n dicate d.
Se vere: Se vere s y m pt o ms ca usi n g i na bilit y t o perf or m us ual s ocial a n d f u ncti o nal 
acti vit ies, wit h i nter ve nti o n or h os pitalizati o n i n dicate d.
I nf usi on- r elate d A E/ S A E i nte nsit y/se verit y s ho ul d be assesse d a n d gra de d acc or di n g t o 
pr ot oc ol  Sectio n  6. 1. 1. 2 .
A n e ve nt is defi ne d as “s erio us ” w he n i t meets at least 1 of t he pre defi ne d o utc o mes as 
descri be d i n t he defi nit i on o f a n S A E, N O T w he n it is rate d as se vere.
Assess me nt of C a us alit y

T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y i nter ve nti on a n d 
eac h A E/ S A E.

A “reas o na ble p ossi bilit y” o f a relat i ons hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relat i ons hi p, rat her t ha n a relat i ons hi p ca n n ot be 
r ule d o ut.

T he i n vest i gat or will use cli nical j u d g me nt t o deter mi ne t he relati ons hi p.

Alt er nat i ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her ris k 
fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y int er ve nt i on 
a d mi nistrati o n will be c o nsi dere d a n d i n vest i gate d.

T he i n vest i gat or will als o c o ns ult t he I B a n d/ or Pr o d uct I nf or mati o n, f or mar kete d 
pr o d ucts, i n his/ her assess me nt.

F or eac h A E/ S A E, t he i n vest i gat or m ust
d oc u me nt i n t he me dical n otes t hat he /s he has 
re vie we d t he A E/ S A E a n d has pr o vi de d a n assess me nt of ca usality.

T here m a y be sit u atio ns i n w hic h a n S A E has occ urre d a n d t he i n vest i gat or has 
mi ni mal i nf or mat i on t o i ncl u de i n t he i nit ial re p ort t o S p o ns or or desi g nee. H o we ver, it 
is ver y  i m p ortant  t hat t he i n vesti gat or al wa ys ma ke a n assess me nt of ca usality f or 
e ver y e ve nt bef ore t he i nit ial tra ns missi on of t he S A E data t o S p o ns or or desi g nee.

T he i n vest i gat or ma y c ha n ge his/ her o pi ni on of ca usalit y i n li g ht of f oll ow- u p 
i nf or mat i on a n d se n d a S A E f oll o w -u p re p ort wi t h t he u p date d ca usalit y assess me nt.

T he ca usalit y assess me nt is o ne of t he crit eria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.
F oll o w -u p of A Es a n d S A Es

T he i n vest i gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uat i ons as me dicall y i n dicate d or as re q ueste d b y S p o ns or or 
desi g nee t o el uci date t he nat ure a n d/ or ca usalit y of  t he A E or S A E as f ull y as p ossi ble. 

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 4
T his m a y i ncl u de a d dit i on al  la b orat or y tests or i n vesti gati o ns, hist o pat h ol o gical 
e xa mi nat i ons, or c o ns ultati o n wit h ot her healt h care pr ofessi o nals.

If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g nize d f oll ow- u p 
p eri o d, t he i n v estigat or will pr o vi de S p o ns or or desi g nee wit h a c o p y  of a n y 
p ost -m o rte m fi n di n gs i ncl u di n g hist o pat h ol o g y. 

Ne w or u p date d i nf or mat i on will be rec or de d i n t he ori gi nall y c o m p lete d C R F.

T he i n vest i gat or will s u b mit a n y u p date d S A E data t o S p o ns or or desi gnee wit hi n 2 4 
h o urs of recei pt of t he i nf or mat i on. 
1 0. 3. 4.
Re p orti n g of S A Es
S A E Re p orti n g vi a a n Electr o nic D at a C ollecti o n T o ol

T he pri mar y  mec ha nis m for re p orti n g a n S A E will be t he electr o nic data c ollect i on 
t o ol.

If t he electr o nic s yste m is u na vaila ble, t he n t he site will use t he pa per S A E data 
c ollect i on t o ol  (see ne xt sectio n) i n or der t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E data i nt o t he electr o nic s y st e m as s o o n as it bec o mes 
a vaila ble.

After t he st u d y  is c o mplete d at a gi ve n site, t he electr o nic data c ollect i on t o ol  will be 
ta ke n off-li ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xist i n g data.

If a site recei ves a re p ort of a ne w S A E fr om a st u d y partici pa nt or recei ves u p date d 
da ta o n a pre vio usl y  re p orte d S A E after t he electr o nic data c ollecti o n t o ol has bee n 
ta ke n off-li ne, t he n t he site ca n re p ort t his i nf or mati on o n a pa per S A E f or m (see ne xt 
secti on) or t o t he s p o ns or b y tele p h o ne.

C o ntacts f or S A E re p orti n g ca n be f o u n d i n site trai ni n g d oc u me nts.
S A E Re p orti n g vi a P a per C R F

Facsi mile tra ns missi o n of t he S A E pa per C R F is t he preferre d met h o d t o tra ns mit t his 
i nf or mat i on t o t he s p o ns or.

I nitial notificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vest i gat or t o 
c o mplete a n d si g n t he S A E C R F pa ges wit hi n t he desi g nate d re p orti n g ti me fra mes.

C o ntacts f or S A E re p orti n g ca n be f o u n d i n site trai ni n g d oc u me nts.

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10.4.
Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information
10.4.1.
Women
Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below).
If fertility is unclear (e.g., amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study intervention, additional evaluation should be considered.
Woman not of Childbearing Potential
Women in the following categories are not considered WOCBP
1. Premenarchal
2. Premenopausal female with either
a.
Documented hysterectomy
b. Documented bilateral salpingectomy, or
c.
Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the above, 
(e.g., mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry. 
Note: Determination can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
3. Postmenopausal female is defined as, women with:
a.
12 months of amenorrhea for women >55, with no need for FSH
b. 12 months of amenorrhea for women >40 years old with FSH ≥40 mIU/mL and 
no other medical condition such as anorexia nervosa and not taking medications 
during the amenorrhea (e.g. oral contraceptives, hormones, gonadotropin 
releasing hormone, anti-estrogens, selective estrogen receptor modulators 
(SERMs), or chemotherapy that induced amenorrhea)
Participation in the Study
Women of child-bearing potential may participate in this study.
Women of child-bearing potential must test negative for pregnancy prior to initiation of 
treatment as indicated by a negative urine pregnancy test at the screening visit.
Women of child-bearing potential who are completely abstinent or in a same sex relationship, as 
part of their preferred and usual lifestyle, must agree to either remain abstinent or stay in a same 
sex relationship without sexual relationships with males.
All other women of child-bearing potential must agree to use two forms of effective 
contraception, where at least one form is highly effective (less than 1% failure rate), for the 
entirety of the study.  

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Abstinence or contraception must continue for 90 days after the last dose of intervention.
Acceptable Methods of Contraception
Highly effective methods of contraception (less than 1% failure rate) comprise, but are not 
limited to

combination oral contraceptives 

implanted contraceptives, or 

intrauterine devices. 
Effective methods of contraception comprise but are not limited to diaphragms with spermicide 
or cervical sponges.  
Not Acceptable Methods of Contraception
Use of male and female condoms as a double barrier method is not considered acceptable due to 
the high failure rate when these barrier methods are combined. 
Barrier protection methods without concomitant use of a spermicide are not an effective or 
acceptable method of contraception.  
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), 
declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable 
methods of contraception.
10.4.2.
Men
Men, regardless of their fertility status, must agree to either remain abstinent (if this is their 
preferred and usual lifestyle) or use condoms as well as one additional highly effective method 
of contraception (less than 1% failure rate) or effective method of contraception with non-
pregnant women of child bearing potential partners for the duration of the study and until their 
plasma concentrations are below the level that could result in a relevant potential exposure to a 
possible fetus, predicted to be 90 days after the last dose.
Men with pregnant partners should use condoms during intercourse for the duration of the study 
and until the end of estimated relevant potential exposure to the fetus, predicted to be 90 days 
after the last dose.
Acceptable Methods of Contraception
Highly effective methods of contraception (less than 1% failure rate) comprise, but are not 
limited to

combination oral contraceptives 

implanted contraceptives, or 

intrauterine devices. 
Effective methods of contraception comprise but are not limited to diaphragms with spermicide 
or cervical sponges.  
Men and their partners may choose to use a double–barrier method of contraception that must 
include use of a spermicide.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 7
Ot her G ui d a nce
Me n
s h o uld r ef r ai n fr o m s per m d o nati on f or t he d uratio n of  t he st u d y a n d u ntil t heir plas ma 
c o nce ntrati o ns are bel o w t he le vel t hat c o ul d res ult  i n a r ele va nt p ote ntial e xp os ure t o a p ossi ble 
fet us, pre dicte d t o be 9 0 da ys after t he last d ose.
1 0. 4. 3.
C ollecti o n of Pre g n a nc y I nf or m ati o n
M ale p artici p a nts wit h p art ners w h o bec o me pre g n a nt
T he i n vest i gat or will atte m pt t o c ollect pre g na nc y i nf or mati on o n a n y male partici pa nt’s fe male 
part ner w h o bec o mes pre g na nt w hile t he male partici pa nt is i n t his st u d y . T his a p plies o nl y t o 
male partici pa nts w h o recei ve st u d y int er ve nt i on.
After o btai ni n g t he necessar y  si g ne d i nf or me d c o nse nt fr o m t he pre g na nt fe male part ner directl y, 
t he i n vest i gat or will rec or d pre g na nc y i nf or mati on o n t he a p pr o priate f or m a n d s u b mit it t o t he 
s p o ns or wit hi n 2 4 h o urs of  lear ni n g of t he part ner’s pre g na nc y. 
T he fe male part ner will als o be f o ll owe d t o deter mi ne t he o utc o me of t he pre g na nc y . I nf or matio n 
o n t he stat us of t he m ot her a n d c hil d will be f or war de d t o t he s p o ns or. Ge nerall y, t he f o ll ow- u p 
wi ll be n o l o n ger t ha n 6 t o 8 wee ks f oll o wi n g t he esti mate d deli ver y  date. A n y ter mi natio n of  t he 
pre g na nc y will be re p orte d i ncl u di n g fetal stat us ( prese nce or a bse nce of a n o malies) a n d 
i n dicati on f or t he pr oce d ure. 
Fe m ale P artici p a nts w h o bec o me pre g n a nt
T he i n vest i gat or will c ollect pre g na nc y i nf or mati o n o n a n y fe male partici pa nt w h o bec o mes 
pre g na nt w hile part ici pati n g i n t his st u d y.  T he i nitial i nf or mati o n will be rec or de d o n t he 
a p pr o priate f or m a n d s u b mitte d t o t he s p o ns or wit hi n 2 4 h o urs of  lear ni n g of  a partici pa nt's 
pre g na nc y. 
T he parti ci pa nt will be f o ll owe d t o deter mi ne t he o utc o me of t he pre g na nc y . T he i n vesti gat or 
will c o llect f oll ow- u p i nf or m at i on o n t he partici pa nt a n d t he ne o nate a n d t he i nf or mat i on will be 
f or war de d t o t he s p o ns or. Ge nerall y, f oll ow- u p will n ot be re q uire d f or l o n ger t ha n 6 t o 8 wee ks 
be y o n d t he est i mate d deli ver y date. A n y ter mi nati o n of pre g na nc y will be re p orte d, i ncl u di n g 
fetal stat us ( prese nce or a bse nce of a n oma lies) or i n dicati on f or t he pr oce d ure.
W hile pre g na nc y  itself is n ot c o nsi dere d t o be a n A E or S A E, a n y pre g na nc y c o mplicat i on or 
elect i ve ter mi nati o n of a pre g na nc y for m e dical reas o ns will be re p orte d as a n A E or S A E. 
A s p o nta ne o us a b orti o n ( occ urri n g at < 2 0 wee ks gestati o nal a ge) or still birt h ( occ urri n g at > 2 0 
wee ks gestati o nal a ge) is al wa ys c o nsi dere d t o be a n S A E a n d will be re p orte d as s uc h. 
A n y p ost -stu d y pre g na nc y relate d S A E c o nsi dere d reas o na bl y relate d t o t he st u d y i nter ve nti o n 
b y t he i n vesti gat or will be re p orte d t o t he s p o ns or as descri be d i n Se ct i on  8. 3. 5 . W hile t he 
i n vesti gat or is n ot o bli gate d t o acti vel y see k t his i nf or mati on i n f or mer st u d y parti ci pa nts, he or 
s he ma y lear n of a n S A E t hr o u g h s p o nta ne o us re p orti n g.
A n y fe male part ici pa nt w h o bec o mes pre g na nt w hile partici pati n g i n t he st u d y will be wit h dra w n 
fr om t he st u d y a n d will fol l ow t he sta n dar d disc o nti n uat i on pr ocess.  

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
8 8
1 0. 5.
A p pe n di x 5: G e netics
S a m ple c ollect i on i nf or mati on is f ou n d i n Sect i on  1 0. 1. 1 2 , A p pe n di x 1.
Use/ A n al ysis of D N A
Ge net ic variat i on ma y i m pact a partici pa nt’s res p o nse t o stu d y i nter ve nt i on, s usce pt i bility t o, a n d 
se verity a n d pr o gressio n of  disease. Varia ble res p o nse t o st u d y  int er ve nt i on ma y be d ue t o 
ge net ic deter mi na nts t hat i m pact dr u g a bs or pti o n, distri b uti on, meta b o lis m, a n d e xcretio n; 
mec ha nis m o f actio n of  t he dr u g; di sease eti ol og y; a n d/ or m ol ec ular s u bt y pe of t he disease bei n g 
treate d. T heref ore, w here l ocal re g ulati o ns a n d I R B/I E C all o w , a bl o o d sa mple will be c o llecte d 
f or D N A a nal ysis fr om c o nse nti n g part ici pa nts.
D N A sa m ples ma y be use d f or researc h relate d t o S A R S -C o V - 2 a n d relate d diseases. T he y ma y 
als o be use d t o de vel o p tests/assa ys i ncl u di n g dia g n ostic tests relate d t o L Y 3 8 1 9 2 5 3 , 
L Y 3 8 3 2 4 7 9, or S A R S -C o V - 2.  Ge netic researc h ma y c o nsist of t he a nal ysis of o ne or m o re 
ca n di date ge nes or t he a nal ysis of ge net ic mar kers t hr o u g h o ut t he ge n o me as a p pr o priate.
T he sa m ples ma y be a nal yze d as part of a m ulti-st u d y assess me nt of ge netic fact ors i n v ol ve d i n 
t he res p o nse t o L Y 3 8 1 9 2 5 3 , L Y 3 8 3 2 4 7 9, or st u d y  int er ve nt i ons of t his class t o u n dersta n d st u d y 
di sease or relate d c o n ditio ns.
T he res ults of ge net ic a nal yses ma y be re p orte d i n t he C S R or i n a se parate st u d y s u m mar y.
T he s p o ns or will st ore t he D N A sa m ples i n a sec ure st ora ge s pace wit h a de q uate meas ures t o 
pr otect c o nfi de nt iality.
T he sa m ples will be retai ne d at a facilit y selecte d b y t he s p o ns or or its desi g nee w hile researc h 
o n S A R S -C o V - 2 c o nt i n ues b ut n o l o n ger t ha n 7 ye ars or ot her peri o d as per l ocal re q uire me nts. 

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10.6.
Appendix 6: Recommended Laboratory Testing for Hypersensitivity 
Events
Laboratory assessments should be performed if the participant experiences generalized urticaria 
or if anaphylaxis is suspected.

Collect sample after the participant has been stabilized, and within 1 to 2 hours of the 
event; however, samples may be obtained as late as 12 hours after the event as analytes 
can remain altered for an extended period of time.  Record the time at which the sample 
was collected.

Obtain a follow-up sample at the next regularly scheduled visit or after approximately 4 
weeks, whichever is later.

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Clinical Lab Tests for Hypersensitivity Events
Hypersensitivity Tests
Notes
Selected test may be obtained in the event of anaphylaxis or 
systemic allergic/hypersensitivity reactions.
LY3819253 and LY3832479
antidrug antibodies 
(immunogenicity/ADA)
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
LY3819253 and LY3832479
concentrations (PK)
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Tryptase
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Urine N-methylhistamine testing is performed in addition to 
tryptase testing.  Collect the first void urine following the event. 
Collect a follow-up urine sample after approximately 4 weeks.
Note: If a tryptase sample is obtained more than 2 hours after the 
event (that is, within 2 to 12 hours), or is not obtained because 
more than 12 hours have lapsed since the event, collect a urine 
sample for N-methylhistamine testing. 
N-methylhistamine
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Drug-specific IgE
Will be performed if a validated assay is available.
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Basophil activation test
Will be performed if a validated assay is available.
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
NOTE: The basophil activation test is an in vitro cell based assay 
that only requires a serum sample. It is a surrogate assay for drug 
specific IgE but is not specific for IgE.
Complement (C3, C3a and 
C5a)
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Cytokine panel
Assayed by Lilly-designated laboratory. 
Results will not be provided to the investigative sites.
Abbreviations: ADA = antidrug antibody; IgE = immunoglobulin E; PK = pharmacokinetic.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
9 1
1 0. 7.
A p pe n di x 7: Li ver S afet y: S u g geste d Acti o ns a n d F oll o w -u p 
Assess me nts
Cl ose He p atic M o nit ori n g
T his ta ble descri bes w he n cl ose he pat ic m o nit ori n g s h o ul d occ ur.
If a partici pa nt wit h baseli ne res ults 
of ... 
de vel o ps t he f oll o wi n g ele vati o ns …
A L T or A S T < 1. 5 × U L N
A L T or A S T ≥3 × U L N
A L P < 1. 5 × U L N
A L P ≥2 × U L N
T B L < 1. 5 × U L N
T B L ≥2 × U L N (e xce pt f or partici pa nts wit h Gil bert’s 
s yn dr o me)
A L T or A S T ≥1. 5 × U L N
A L T or A S T ≥2 × baseli ne
A L P ≥1. 5 × U L N
A L P ≥2 × baseli ne
T B L ≥1. 5 × U L N
T B L ≥2 × baseli ne (e xce pt f or partici pa nts wit h 
Gil bert’s s y n dr o me)
A b bre viati o ns:  A L P = al kali ne p h os p hatase; A L T = ala ni ne a mi n otra nsferase; A S T = as partate
a mi n otra nsferase; T B L = t otal bilir u bi n; U L N = u p per li mit of n or mal.
T he l a b orat or y tests liste d i n Sect i on  1 0. 2 , A p pe n di x 2, i ncl u di n g ala ni ne a mi n otra nsferase 
(A L T ), A S T, A L P, t otal bilir u bi n (T B L ), di rect bilir u bi n, ga m ma-gl uta m yl  tr a nsferase, a n d 
creati ne ki nase, s h o ul d be re peate d w he n m o nit ori n g la bs are perf or me d.
If t he a b n or mality persists or w orse ns, cli nical a n d la b orat or y  mo ni t ori n g, a n d e val uat i on f or t he 
p ossi ble ca uses of t he a b n or mal li ver tests s h o ul d be i nit iate d b y t he i n vestig at or i n c o ns ul t atio n 
wi t h t he s p o ns or.
At  a mi ni m u m, t his e val uati on s h o ul d i ncl u de a p h ysical e xa mi nat i on a n d a t h or o u g h me dical 
hist or y , i ncl u di n g s y m pt o ms, rece nt ill nesses (f or e xa m ple, heart fail ure, s yste mic i nfect i on, 
h y p ote nsi o n, seiz ures) rece nt tra vel, hist or y of c o nc o mita nt me dicat i ons (i ncl u di n g o ver -t he-
c o u nter), her bal a n d dietar y s u p ple me nts, hist or y of alc o h ol use , a n d ot her s u bsta nce a b use.
I nitiall y, mo ni t ori n g of s y m pt o ms a n d he patic bi oc he mical tests s h o ul d be d o ne at a fre q ue nc y o f 
bet we e n 3 ti mes wee kl y a n d e ver y ot her wee k, base d o n t he partici pa nt’s cli nical c o n diti on a n d 
he pat ic bi oc he mical tests.  S u bse q ue ntl y, t he fre q ue nc y o f m o nit ori n g ma y  be lo were d t o o nce 
e ver y 1 t o 2 wee ks if t he part ici pa nt’s cli nical c o n diti on a n d la b orat or y res ults sta bilize.  
M o ni t ori n g of A L T, A S T, A L P, a n d T B L s h o ul d c o nti n ue u ntil le vels n or malize or ret ur n t o 
a p pr o xi mate baseli ne le vels.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
9 2
C o m pr e he nsi ve He p atic E v al u ati o n  
A c o m pre he nsi ve e val uat i on s h o ul d be perf or m e d t o searc h f or p ossi ble ca uses of li ver i nj ur y if 
o ne or m ore of t hese c o n dit i ons occ ur:
If a partici pa nt wit h baseli ne 
res ults of... 
de vel o ps t he f oll o wi n g ele vati o ns …
A L T or A S T < 1. 5 × U L N
A L T or A S T ≥3 × U L N wit h he patic si g ns/s y m pt o ms *, or
A L T or A S T ≥5 × U L N
A L P < 1. 5 × U L N
A L P ≥3 × U L N
T B L < 1. 5 × U L N
T B L ≥2 × U L N (e xce pt f or partici pa nts wit h Gil bert’s s y n dr o me)
A L T or A S T ≥1. 5 × U L N
A L T or A S T ≥2 × baseli ne wit h he patic si g ns/s y m pt o ms *, or
A L T or A S T ≥3 × baseli ne
A L P ≥1. 5 × U L N
A L P ≥2 × baseli ne
T B L ≥1. 5 × U L N
T B L ≥1. 5 × baseli ne (e xce pt f or partici pa nts wit h Gil bert’s s y n dr o me) 
* He p atic si g ns/s y m pt o ms are se vere f ati g ue, n a use a, v o miti n g, ri g ht u p per q u a dr a nt a b d o mi n al p ai n, fe ver, r as h, a n d/ or 
e osi n o p hili a > 5 %.
A b bre viati o ns:  A L P = al kali ne p h os p hatase; A L T = ala ni ne a mi n otra nsferase; A S T = as partate
a mi n otra nsferase; T B L = t otal bilir u bi n; U L N = u p per li mit of n or mal.
At  a mi ni m u m, t his e val uati on s h o ul d i ncl u de p h ysical e xa mi nat i on a n d a t h or o u g h me dical 
hist or y, as o utli ne d a b o ve, as well as tests f or P T -I N R; tests f or viral he patitis A, B, C, or E; tests 
f or a ut oi m m u ne he patitis; a n d a n a b d o mi nal i ma gi n g st u d y (for e xa m ple, ul tras o u n d or C T sca n).
Base d o n t he partici pa nt ’s hist or y  a n d i nitial r es ults, furt her testi n g s h o ul d be c o nsi dere d i n 
c o ns ultatio n wi t h t he Lill y-desi g nate d m e dical mo ni t or, i ncl u di n g tests f or he patitis D vir us 
( H D V), c yt o me galo vi r us ( C M V), E pstei n-Barr vi r us ( E B V), aceta mi n o p he n le vels, 
aceta mi n o p he n pr otei n a d d ucts, uri ne t o xic o l og y  scree n, Wils on’ s disease, bl o o d alc o h ol le vels, 
uri nar y  et h yl gl uc ur o ni de, a n d ser u m p h os p hati dylet ha n o l.
Base d o n t he circ u msta nces a n d t he i n vest i gat or’s assess me nt of t he partici pa nt’s cli nical 
c o n ditio n, t he i n vest i gat or s h o ul d c o nsi der referri n g t he partici pa nt f or a he pat ol o gist or 
gastr oe nter ol o gi st c o ns ult atio n, m a g net ic res o na nce c h olan gi o pa ncreat o gra p h y  ( M R C P), 
e n d osc o pic retr o gra de c h ola n gi o pa ncreat o gra p h y ( E R C P), car diac ec h ocar dio gra m , or a li ver 
bi o ps y.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
9 3
A d diti o n al He p atic D at a C ollecti o n ( He p atic S afet y C R F) 
A d diti o nal he patic safet y d ata c ollecti o n i n he patic safet y C R Fs s h o ul d be perf or me d i n st u d y partici pa nts 
w h o eit her ha ve a he patic e ve nt c o nsi dere d t o be a n S A E or meet 1 or m ore of t hese c o n diti o ns:
If a p artici p a nt wit h b aseli ne...
h as t he f oll o wi n g ele v ati o ns …
A L T < 1. 5 × U L N
A L T ≥5 × U L N o n 2 or m ore c o nsec uti ve bl o o d tests 
A L P < 1. 5 × U L N
A L P ≥2 × U L N o n 2 or m ore c o nsec uti ve bl o o d tests
T B L < 1. 5 × U L N
T B L ≥2 × U L N, e xce pt f or cases of k n o w n Gil bert’s s y n dr o me
A L T ≥1. 5 × U L N
A L T ≥3 × baseli ne o n 2 or m ore c o nsec uti ve bl o o d tests
A L P ≥1. 5 × U L N
A L P ≥2 × baseli ne o n 2 or m ore c o nsec uti ve bl o o d tests
T B L ≥1. 5 × U L N
T B L ≥2 × baseli ne
A b bre viati o ns:  A L P = al kali ne p h os p hatase; A L T = ala ni ne a mi n otra nsferase; A S T = as partate
a mi n otra nsferase; T B L = t otal bilir u bi n; U L N = u p per li mit of n or mal.
N ote:  T he i nter val bet wee n t he 2 c o nsec uti ve bl o o d tests s h o ul d be at least 2 da ys.
He p atic E v al u ati o n Testi n g
T he Lill y -desi g nate d ce ntral la b orat or y  must c o m plete t he a nal ysis of all selecte d testi n g e xce pt 
f or micr o biol o g y  testi n g.
L ocal  testi n g ma y be perf or me d i n a d diti on t o ce ntral testi n g w he n necessar y f or i m me diate 
parti ci pa nt ma na ge me nt.
Res ults will be re p orte d if a vali date d test or calc ulati o n is a vaila ble.
He m at ol o g y
Cli nic al C he mistr y
He m o gl o bi n
T otal bilir u bi n
He mat ocrit
Direct bilir u bi n
Er y t hr oc ytes ( R B Cs - re d bl o o d cells)
Al kali ne p h os p hatase ( A L P)
Le u k oc ytes ( W B Cs - w h ite bl o o d cells)
Ala ni ne a mi n otra nsferase ( A L T)
Differe ntial:
As partate a mi n otra nsferase ( A S T)
    Ne utr o p hils, se g me nte d
Ga m ma -gl uta m yl tra nsferase ( G G T)
    L y m p h oc ytes
Creati ne ki nase ( C K)
    M o n oc yt es
Ot her C he mistr y
    Bas o p hils
Aceta mi n o p he n
    E osi n o p hils
Aceta mi n o p he n pr otei n a d d ucts
Platelets
Al kali ne p h os p hatase is oe nz y mes
Cell m or p h ol o g y ( R B C a n d W B C)
Cer ul o plas mi n
C o a g ul ati o n
C o p per
Et h y l alc o h ol ( Et O H)
Pr ot hr o m bi n ti me, I N R ( P T -I N R)
Ha pt o gl o bi n
Ser ol o g y
I m m u n o gl o b uli n I g A ( q ua ntitati ve)

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Hepatitis A virus (HAV) testing:
Immunoglobulin IgG (quantitative)
    HAV total antibody
Immunoglobulin IgM (quantitative)
    HAV IgM antibody
Phosphatidylethanol (PEth)
Hepatis B virus (HBV) testing:
Urine Chemistry
    Hepatitis B surface antigen (HBsAg)
Drug screen
    Hepatitis B surface antibody (anti-HBs)
Ethyl glucuronide (EtG)
    Hepatitis B core total antibody (anti-HBc)
Other Serology
    Hepatitis B core IgM antibody
Anti-nuclear antibody (ANA)
    Hepatitis B core IgG antibody
Anti-smooth muscle antibody (ASMA) a
    HBV DNA b
Anti-actin antibody c
Hepatis C virus (HCV) testing:
Epstein-Barr virus (EBV) testing:
    HCV antibody
    EBV antibody
    HCV RNA b
    EBV DNA b
Hepatitis D virus (HDV) testing:
Cytomegalovirus (CMV) testing:
    HDV antibody
    CMV antibody
Hepatitis E virus (HEV) testing:
    CMV DNA b
    HEV IgG antibody
Herpes simplex virus (HSV) testing:
    HEV IgM antibody
    HSV (Type 1 and 2) antibody 
    HEV RNA b
    HSV (Type 1 and 2) DNA b
Microbiology d
Liver kidney microsomal type 1 (LKM-1) antibody
Culture:
    Blood
    Urine
a
Not required if anti-actin antibody is tested.
b
Reflex/confirmation dependent on regulatory requirements, testing availability, or both.
c
Not required if anti-smooth muscle antibody (ASMA) is tested.
d
Assayed ONLY by investigator-designated local laboratory; no central testing available.

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10.8.
Appendix 8: Abbreviations
Term
Definition
ADA
antidrug antibody
ADE
antibody-dependent enhancement
AE
adverse event
ALT
alanine aminotransferase
ANOVA
analysis of variance 
AST
aspartate aminotransferase
blinding/masking
A single-blind study is one in which the investigator and/or his staff are aware of the 
treatment but the participant is not, or vice versa, or when the sponsor is aware of the 
treatment but the investigator and/his staff and the participant are not.
A double-blind study is one in which neither the participant nor any of the investigator or 
sponsor staff who are involved in the treatment or clinical evaluation of the subjects are 
aware of the treatment received.
Companion diagnostic 
An in vitro diagnostic device (assay or test) that provides information that is essential for 
the safe and effective use of a corresponding therapeutic product
complaint
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, purity, durability, reliability, safety or effectiveness, or 
performance of a drug or drug delivery system.
compliance
Adherence to all study-related, good clinical practice (GCP), and applicable regulatory 
requirements.
COVID-19
Coronavirus disease - 2019
CRF
Case report form
CRP
clinical research physician: Individual responsible for the medical conduct of the study.  
Responsibilities of the CRP may be performed by a physician, clinical research scientist, 
global safety physician or other medical officer.
CRS
Clinical research scientist
CSR
clinical study report
CTA
Clinical trial agreement
DAIDS
Division of AIDS
DMC
Data monitoring committee; functionally equivalent to DSMB for this study
DSMB
Data safety monitoring board
Device Deficiencies
Equivalent to product complaint

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EDC
Electronic data capture
enroll
The act of assigning a participant to a treatment.  Participants who are enrolled in the study 
are those who have been assigned to a treatment.
enter
Participants entered into a study are those who sign the informed consent form directly or 
through their legally acceptable representatives.
Facility
The physical location for the conduct of study procedures. This will be the skilled nursing 
and assisted living facilities associated with the nursing home network. 
See also “Skilled nursing and Assisted Living facility”.
Facility staff
Participants who are staff of the facility.  For “facility”, see “Facility” and “Skilled nursing 
and Assisted Living facility”.
Contrast to “Site staff”
GCP
good clinical practice
IB
Investigator’s Brochure
ICF
informed consent form
IgG1
immunoglobulin G1
Informed consent
A process by which a participant voluntarily confirms his or her willingness to participate 
in a particular study, after having been informed of all aspects of the study that are relevant 
to the participant’s decision to participate.  Informed consent is documented by means of a 
written, signed and dated informed consent form.
interim analysis
An interim analysis is an analysis of clinical study data, separated into treatment groups, 
that is conducted before the final reporting database is created/locked.
IP
investigational product
IRB/IEC
Institutional review board / independent ethics committee 
ITT
intent to treat:  The principle that asserts that the effect of a treatment policy can be best 
assessed by evaluating on the basis of the intention to treat a participant (that is, the 
planned treatment regimen) rather than the actual treatment given.  It has the consequence 
that participant allocated to a treatment group should be followed up, assessed, and 
analyzed as members of that group irrespective of their compliance to the planned course 
of treatment.
IV
intravenous
IWRS
interactive web-response system
LS mean
least-squares mean
mAb
monoclonal antibody
MMRM
mixed-effects model for repeated measures

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NIAID
National Institute of Allergy and Infectious Diseases
participant
Equivalent to CDISC term “subject”: an individual who participates in a clinical trial, 
either as recipient of an investigational medicinal product or as a control
PK/PD
pharmacokinetics/pharmacodynamics
POC
Point of care test.  In this study, the POC test is a rapid POC test that returns results in 
minutes.
Prevention Cohort
Participants in Part 2 who test negative during screening on the POC test.
Contrast with “Treatment Cohort”.
RT-PCR
reverse transcription – polymerase chain reaction
SAE
serious adverse event
SAP
statistical analysis plan
SARS
severe acute respiratory syndrome
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
screen
The act of determining if an individual meets minimum requirements to become part of a 
pool of potential candidates for participation in a clinical study. 
Site
The physical location of the primary investigator and associated study staff who will 
conduct study procedures at the facilities. 
Site staff
Site personnel who perform study tasks.  
Contrast to “Facility staff”
Skilled nursing and
Assisted Living facility
This terminology is intended to be broad and is inclusive of skilled nursing, assisted living, 
long-term care, or nursing home facilities.  Memory care units in any of the above can be 
included.  Also, this terminology includes residents who may need only short-term care.
SoA
Schedule of Activities
TBL
total bilirubin
TE-ADA
treatment-emergent antidrug antibody
TE-ADA+
treatment-emergent antidrug antibody positive
TEAE
treatment-emergent adverse event:  An untoward medical occurrence that emerges during a 
defined treatment period, having been absent pretreatment, or worsens relative to the 
pretreatment state, and does not necessarily have to have a causal relationship with this 
treatment.
Treatment Cohort
Participants in Part 2 who test positive during screening on the POC test.
Contrast with “Prevention Cohort”.
WOCBP
women of childbearing potential

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10.9.
Appendix 9: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents (TOC).
Amendment c
Overall Rationale for the Amendment:
The sponsor is adding Part 3 of Study PYAD.
Part 3 of the study is a two arm, outpatient, open label, exploratory cohort evaluating the efficacy 
and safety of LY3819253 and LY3819253 in combination with LY3832479 in participants 
positive for SARS-CoV-2 with or without symptoms in staff and residents who are at higher risk 
for more severe disease and hospitalization in skilled nursing and assisted living facilities.
Section # and Name
Description of Change
Brief Rationale
1.1 Synopsis
Updated text to match the body 
of the protocol for Objectives and 
Endpoints, Overall Design, 
Number of Participants, and 
Intervention Groups and 
Duration.
Updates were made to the associated 
sections.  
See rationale for these sections below.
1.2 Schema
Part 3 schema added. 
Activation of Part 3.
1.2 Schema
4.1.2 Evaluation Period
6.1 Study Intervention(s) 
Administered
9.3 Populations for 
Analyses
Modified dose for Part 2 Treatment
To align to the current dosing strategy being 
evaluated in the treatment studies evaluating 
monotherapy and combination therapy.
1.3.2 Part 2 Treatment 
Cohort and Part 3
Modified subsection title to reflect 
addition of Part 3.  
Added note for inclusion and 
exclusion criteria review, “Note that 
eligibility criteria for Part 2 and Part 
3 are different.”
Added row for documentation of 
positive SARS-CoV-2 infection. 
Activation of Part 3. 
Clarification.
Activation of Part 3.
3 Objectives and 
Endpoints
Added Part 3 exploratory treatment 
objectives
Added, “Safety, pharmacokinetics, 
and antidrug antibodies will be 
characterized in the overall intent to 
treat population and in the analysis 
populations” to Part 2 and Part 3 
exploratory objectives and endpoints 
table.  Updated Part 2 heading.
Activation of Part 3.
Clarification. 
4.1.1 Screening Period
Added screening description for Part 
3.
Activation of Part 3.

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Section # and Name
Description of Change
Brief Rationale
4.1.2 Evaluation Period
Modified description of Part 2 
activation.
Added evaluation period description 
for Part 3.
Clarification on activation of Part 2.
Activation of Part 3.
4.1.3 Follow-up Period
Added Part 3 to subheader: Part 2 
Treatment Cohort and Part 3.
Activation of Part 3. 
4.2 Scientific Rationale 
for Study Design
Added rationale for study design of 
Part 3. 
Activation of Part 3.
4.3 Justification for Dose
Added justification for doses chosen 
for Parts 2 and 3.
Activation of Part 3. 
5.1 Inclusion Criteria
Added criteria 19 and 20 for 
participants of Part 3.  
Clarified criterion 2.
Part 3 population will consist of participants 
who are at higher risk for more severe 
disease and hospitalization.
Clarification:  only applies to Parts 1 and 2.
6.1 Study Intervention(s) 
Administered
Updated dose level for study 
intervention and Part 3.
Updated monitoring for infusion 
times less than 30 minutes.
Activation of Part 3.
6.3 Measures to 
Minimize Bias: 
Randomization and
Blinding
Added statement that Part 3 is open 
label.
Activation of Part 3.
8.1.1 SARS-CoV-2 Viral 
Swab and Serology
Added description of viral swab for 
Part 3.
Activation of Part 3.
9.1 Statistical 
Hypotheses
Added description of Part 3 analyses.
Clarified Part 1 and Part 2 
information. 
Activation of Part 3.
Clarification.
9.2 Sample Size 
Determination
Added sample size for Part 3.
Activation of Part 3.
9.3 Populations for 
Analyses
Added Part 3 populations and 
treatment groups.
Activation of Part 3.
9.4 Statistical Analyses
Added description of Part 3 analyses. 
Activation of Part 3.
9.4.7 Exploratory 
Endpoints
Added description of Part 3 analyses.
Clarified Part 1 and Part 2 
information.  
Activation of Part 3.
Clarification.
11 References
Added FDA EUA fact sheet
Addition of reference.
Throughout the protocol
Minor editorial and formatting 
changes
Minor, therefore not described.

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Amendment b (6 November 2020)
Overall Rationale for the Amendment:
This amendment addresses changes to the follow-up period for the treatment cohort in Part 2 per 
FDA feedback.  The FDA recommended a follow-up period of at least 5 half-lives of the 
intervention.  The follow-up period is changed from Day 57 to Day 85 and the maximum total 
duration of study for each participant in the treatment cohort is changed from 8 weeks to 
12 weeks. 
Section # and Name
Description of Change
Brief Rationale
1.1 Synopsis
Post-treatment follow-up changed 
from study day 57 to 85
FDA feedback
1.1 Synopsis
Maximum total duration of study for 
each participant in the treatment 
cohort is changed from 8 weeks to 
12 weeks
Change in follow-up period duration
1.2 Schema
Part 2 schema updated with change 
in follow-up period from 8 weeks to 
12 weeks
Change in follow-up period duration
1.3.2 Part 2 Treatment 
Cohort Schedule of 
Activities (SoA)
Post-treatment follow-up changed 
from study day 57 to 85
FDA feedback
4.1.2 Evaluation Period
Follow-up changed from study day 
57 to 85 
FDA feedback
4.1.2 Evaluation Period
Maximum total duration of study for 
each participant in the treatment 
cohort is changed
Change in follow-up period duration
4.1.2 Evaluation Period
Treatment cohort visit type table 
updated from study day 57 to 85
FDA feedback
4.1.3 Follow-up Period
Part 2 Treatment Cohort changed 
post-evaluation follow-up 
assessment from study day 57 to 85
FDA feedback
Throughout the protocol
Minor editorial and formatting 
changes
Minor, therefore not described.

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Amendment a (27 October 2020)
Overall Rationale for the Amendment:
The sponsor is adding Part 2 of Study PYAD in order to further investigate the efficacy and 
safety of a lower dose level of LY3819253 and the combination intervention of LY3819253 and 
LY3832479 in preventing SARS-CoV-2 infection and COVID-19 in skilled nursing and assisted 
living facility residents and staff.
The primary endpoint for Part 1 and Part 2 has been changed to cumulative incidence of COVID-
19 defined as the detection of SARS-CoV-2 by RT-PCR AND mild or worse disease severity 
within 21 days of detection [time frame for endpoint evaluation: 8 weeks from randomization]. 
The cumulative incidence of SARS-CoV-2 infection defined as the detection of SARS-CoV-2 by 
RT-PCR within 4 weeks from randomization is now a key secondary endpoint.  
The changes in the primary endpoint aligns closely to the Guidance for Industry: COVID-19: 
Developing Drugs and Biological Products for Treatment or Prevention, 
III.C.:  “In prevention trials, the primary endpoint should be the occurrence of laboratory-
confirmed SARS-CoV-2 infection (with or without symptoms) or SARS-CoV-2 infection 
with symptoms (i.e., COVID-19) through a prespecified time point” (FDA 2020)
Section # and Name
Description of Change
Brief Rationale
Title Page, Synopsis
Title and short title changed to 
include “alone and in 
combination with LY3832479.”
Activation of Part 2 includes evaluation 
of combination therapy with LY3819253 
and LY3832479.
1.1 Synopsis
Updated text to match the body 
of the protocol for Rationale, 
Objectives and Endpoints, 
Overall Design, Number of 
Participants, and Intervention 
Groups and Duration.
Updates were made to the associated 
sections.  
See rationale for these sections below.
In Number of Participants, 
modified description, “…a total 
of approximately 1700 
participants… on average will be 
randomly assigned…”.
Clarity.
1.2 Schema
Added schema for Part 2.
Activation of Part 2.
1.3.1 Part 1 and 
Prevention Cohort of 
Part 2
Added SARS-CoV-2 POC Test 
(nasal swab) at Screening for 
participants in Part 2.
Cohort allocation is dependent on the 
POC test result.
Added “(for PCR test)” to the 
SARS-CoV-2 nasopharyngeal 
and nasal swab test descriptions.
Clarity.
Added comment to PK sample: 
“For participants in Part 2, Day 1 
Collect Cmax data post-infusion in Part 2.

C O N FI D E N TI A L
J 2 X-M C -P Y A D( d); C o V P N # 3 5 0 1
1 0 2
Secti o n # a n d N a me
Descri pti o n of C h a n ge
Brief R ati o n ale
c ollecti o n is p ost-d ose o nl y 
(a p pr o x. 3 0 mi n utes after e n d of 
i nf usi o n).”
1. 3. 2 Part 2 Treat me nt 
C o h ort ( S O A)
A d de d se parate S O A ta ble f or t he 
Part 2 Treat me nt C o h ort.
Partici pa nts w h o test p ositi ve o n t he 
scree ni n g P O C test f or S A R S-C o V - 2 
will be f oll o we d f or a s h orter d urati o n 
( See Secti o n 1. 3. 2 ), as t he y are n ot 
o bser ve d f or t he pre ve nti o n e n d p oi nt a n d 
ar e a n e x pl orat or y treat me nt gr o u p.
2. 1 St u d y Rati o nale
A d de d L Y 3 8 1 9 2 5 3 i n 
c o m bi nati o n wit h L Y 3 8 3 2 4 7 9 t o 
descri pti o n of st u d y ai m.  
C o m bi nati o n t hera p y has bee n a d de d as a 
st u d y i nter ve nti o n gr o up.
2. 2 Bac k gr o u n d
A d de d L Y 3 8 3 2 4 7 9 bac k gr o u n d.
C o m bi nati o n t hera p y has bee n a d de d as a 
st u d y i nter ve nti o n gr o u p.
2. 3 Be nefit/ Ris k 
Assess me nt
A d de d “ N o cli nicall y rele va nt 
off -tar get bi n di n g has bee n 
o bser ve d i n tiss ue cr oss reacti vit y 
st u dies of me m bra ne tar gets i n 
h u ma n tiss ues.”
A d de d i nf or mati o n o n a p ote ntial ris k.
Re m o ve d “ L Y 3 8 1 9 2 5 3 will be 
a d mi nistere d t o partici pa nts at 
s ufficie ntl y hi g h d ose le vels t o 
ne utralize S A R S -C o V -2.”
Rati o nale f or d ose descri be d i n Secti o n 
4. 3.  
A d de d details o n ris k o f cli nical 
A D E a n d reas o ns f or c o nsi deri n g 
sai d ris k as l o w.
A d de d i nf or mati o n o n a p ote ntial ris k.
A d de d refere nces a n d be nefit/ris k 
i nf or mati o n f or L Y 3 8 3 2 4 7 9.
C o m bi nati o n t hera p y has bee n a d de d as a 
st u d y i nter ve nti o n gr o u p.
3 O bjecti ves a n d 
E n d p oi nts
C ha n ge d t he pri mar y e n d p oi nt 
f or t he Part 1 Pre ve nti o n 
P o p ulati o n t o: 

C u m ulati ve i nci de nce of
S A R S -C o V - 2 C O VI D - 1 9
defi ne d as t he detecti o n of 
S A R S -C o V -2 b y R T -P C R 
A N D mil d or w orse disease 
se verit ya wit hi n 2 1 da ys of 
detecti o n

Ti me fra me f or e n d p oi nt 
e val uati o n: 8 wee ks fr o m 
ra n d o mizati o n
E n d p oi nt ali g ns wit h F D A G ui d a nce f or 
I n d ustry: C O VI D-1 9: Devel o pi n g Dr u gs 
a n d Bi ol o gic al Pr o d ucts f or Tre at me nts 
or Preve nti o n, III. C, a n d wit h t he 
pri m ar y e n d p oi nts f or o n g oi n g S A R S -
C o V -2 vacci ne trials.
C ha n ge d t he ke y sec o n dar y 
e n d p oi nt f or Part 1 Pre ve nti o n 
P o p ulati o n t o:
U p date d t he sec o n dar y e n d p oi nt t o 
e val uate pri or pri mar y e n d p oi nt.

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Section # and Name
Description of Change
Brief Rationale

Cumulative incidence of 
COVID-19SARS-CoV-2; 
defined as the detection of 
SARS-CoV-2 by RT-PCR, 
AND mild or worse disease 
severitya within 21 days of 
detection

Time frame for endpoint 
evaluation: 4 weeks from 
randomization
Modified other secondary and 
exploratory endpoints, “Compare 
the frequency of hospitalization 
or death due to COVID-19.”
Added “death” to capture serious disease 
not captured by hospitalization.
Added the objectives and 
endpoints for Part 2 of Study 
PYAD
Added objectives and endpoints for Part 
2 to align with the design of Part 2.
4.1 Overall Design
Added “prophylaxis” to overall 
study description.
Alignment with synopsis.
Added “…alone and in 
combination with LY3832479…” 
to study description.
Combination therapy with LY3832479 
has been added as a study intervention 
group.
4.1.1 Screening Period
Added, “Prior to randomization 
in Part 2, participants will receive 
a point of care (POC) test for 
SARS-CoV-2 infection.  
Participants will be allocated to 
either Prevention or Treatment 
Cohorts based on the result.”
The POC test is used to determine 
allocation to the Prevention or Treatment 
Cohort in Part 2.
4.1.2 Evaluation 
Period
Added, “Participants in Part 1 
will be randomized to placebo or 
LY3819253.  When the needed 
events for the primary and key 
secondary endpoints are 
achieved, and the minimum 
number of residents enroll, the 
sponsor will trigger activation of 
Part 2.”
Ensures that Part 2 occurs after the 
primary endpoint for Part 1 can be 
evaluated.
Added description of the 
Prevention and Treatment 
Cohorts.
Activation of Part 2.
Added a visit type information 
table.
Clarification of visit types.

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Section # and Name
Description of Change
Brief Rationale
Updated Table 1 Definitions for 
COVID-19 Severity:  removed 
definition of Shock.
The definition did not define participants 
in shock.  Clinical judgement will be 
relied on.
4.1.3 Follow-up Period
Provided information on the 
follow-up period for Part 2.
Activation of Part 2.
4.2 Scientific 
Rationale for Study 
Design
Added “alone or in combination 
with LY3832479”.
Combination therapy with LY3832479 
has been added as a study intervention 
group.
Added study design descriptions 
for POC and RT-PCR tests.
Activation of Part 2.
4.3 Justification for 
Dose
Updated to include justification 
for doses used in Part 2.
Activation of Part 2.
5.2 Exclusion Criteria
Added to criterion 7, “Recovered 
from confirmed COVID-19 
disease or asymptomatic 
infection”.
Included recovered from asymptomatic 
infection in exclusion as it is possible 
immunity could be established in people 
with symptomatic or asymptomatic 
disease.  Removed “confirmed” because 
there is no specific definition.
Added to criterion 11, 
“Participation in a previous 
SARS-CoV-2 vaccine trial or 
received an approved SARS-
CoV-2 vaccine.”
Anticipation of an EUA or approved 
vaccine during the study.
Added LY3832479 to 
criterion 16.
Addition of LY3832479 to study.
6.1 Study 
Intervention(s) 
Administered
Added information that describes 
Part 2 treatment groups.
Activation of Part 2.
Changed monitoring from 2 
hours after completion of the 
infusion to 1 hour
Based on available safety data.
6.1.1.1 Premedication 
for Infusions
Modified text, “Premedication 
for infusions is not planned.  
However, if an infusion reaction 
occurs during administration or if 
the participant…”.
Clarity:  participants receive a single 
infusion in this study, so the text is not 
applicable.
6.3 Measures to 
Minimize Bias: 
Randomization and 
Blinding
Added information that describes 
blinding for Part 2.
Activation of Part 2.
Updated table for general 
procedures for unblinding:  
“The date and reason that the 
Clarification.

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105
Section # and Name
Description of Change
Brief Rationale
blind was broken must be 
recorded in the source
documentation and case report 
form.”
Added to the general procedures 
for unblinding table, 
“Participants who test negative at 
screening POC testing, then test 
positive at baseline PCR testing, 
will be unblinded.  Unblinding is 
recorded and reported by the 
IWRS.”
Clarification.
6.5 Concomitant 
Therapy
Updated language on remdesivir, 
“Therefore, remdesivir may be 
initiated as standard of care for 
participants requiring
hospitalizationed with severe 
disease (if available through the 
FDA Emergency Use 
Authorizations) outside of local 
standard of care per written 
policies or guidelines.”
Remdesivir is now approved for 
treatment of hospitalized COVID-19 
patients.
Added, “Vaccines for SARS-
CoV-2 should not be used prior 
to Week 8 of the evaluation 
period for the prevention cohort 
of Part 2.”
SARS-CoV-2 vaccines are prohibited 
during the evaluation period of the 
prevention cohort to maintain 
interpretability of study endpoints.
8.1.1 SARS-CoV-2 
Viral Swab and 
Serology
Added information on the POC 
test.  Edited language to clarify 
test usage in study.
Activation of Part 2.
Added “However, for Part 1, a 
positive result from any baseline 
swab will be sufficient for 
positive baseline RT-PCR 
status.”
Clarification.
8.4 Treatment of 
Overdose
Added “alone or in combination 
with LY3832479.
Activation of Part 2.
8.5 Pharmacokinetics
Added LY3832479.
Activation of Part 2.
8.5.1 Bioanalytical
Added LY3832479.
Activation of Part 2.
8.6 
Pharmacodynamics
Added LY3832479.
Activation of Part 2.
8.8 Biomarkers
Added LY3832479.
Activation of Part 2.
8.9 Immunogenicity
Added LY3832479.
Activation of Part 2.

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J2X-MC-PYAD(d); CoVPN #3501
106
Section # and Name
Description of Change
Brief Rationale
9.1 Statistical 
Hypotheses
Added reference to LY3832479.
Activation of Part 2.
Updated primary endpoint 
description.
Endpoint aligns with FDA Guidance for 
Industry: COVID-19: Developing Drugs 
and Biological Products for Treatments 
or Prevention, III.C, and with the 
primary endpoints for ongoing SARS-
CoV-2 vaccine trials.
9.2 Sample Size 
Determination
Added sample size information 
for Part 2.
Activation of Part 2.
Added dose strength (4200 mg) 
to describe primary endpoint.
Clarification. 
9.3 Populations for 
Analyses
Updated table to include relevant 
Part 2 populations.
Activation of Part 2.
Added table to define study arms 
for purposes of comparison.
Clarity.  
Added description for use of 
specified terms.  
Clarity. 
9.4 Statistical 
Analyses
Added analysis information for 
Part 2.
Activation of Part 2.
9.4.1. General 
Considerations
Modified language, “…for the 
difference between 
LY3819253 each study 
intervention and placebo will 
be reported.”
Addition of LY3832479.
9.4.5 Primary 
Endpoint
Updated primary endpoint.
Endpoint aligns with FDA Guidance for 
Industry: COVID-19: Developing Drugs 
and Biological Products for Treatments 
or Prevention, III.C, and with the 
primary endpoints for ongoing SARS-
CoV-2 vaccine trials.
9.4.6 Secondary 
Endpoints
Updated secondary endpoints.
As described in Section 3.
9.4.6.1 Safety 
Analyses
Removed study drug overdose  
language
Overdose is described in Section 8.4.  
AE definitions are detailed in 
Section 10.3.  
9.4.6.2 
Pharmacokinetic 
Analyses
Added subsection to describe PK 
analyses.
Clarity.

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107
Section # and Name
Description of Change
Brief Rationale
9.4.7 Exploratory 
Endpoints
Modified language to be 
inclusive of all study 
interventions.
Addition of LY3832479.
9.4.8 Other Safety 
Analyses
Updated: “safety measures will 
be summarized with incidence 
rates counts and proportions of 
participants”
Correction.  
9.4.9 Immunogenicity 
Analysis
Modified language to be 
inclusive of all study 
interventions.
Addition of LY3832479.
10.1.7 Data Quality 
Assurance
Added information on the data 
capture system: “If there are 
clinical or business continuity 
needs that do not enable these 
data to be direct data captured, 
these data will be captured as 
source via paper and transcribed 
into EDC.”  
Flexibility.  
10.2 Clinical 
Laboratory Tests
Added “Anti-LY3832479 
antibodies” to immunogenicity 
samples collected
Addition of LY3832479.
10.5 Genetics
Added LY3832479.
Activation of Part 2.
10.6 Recommended 
Laboratory Testing for 
Hypersensitivity 
Events
Added LY3832479.
Activation of Part 2.
10.8 Abbreviations
Added definitions for Prevention 
Cohort and Treatment Cohort.
Clarity.
Throughout the 
protocol
Minor editorial and formatting 
changes
Minor, therefore not described.

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108
11.
References
Arons MM, Hatfield KM, Reddy SC, et al. Presymptomatic SARS-CoV-2 infections and 
transmission in a skilled nursing facility. NEJM. 2020;382(22):2081-90. 
https://doi.org/10.1056/NEJMoa2008457
[CDC] Centers for Disease Control and Prevention. Nursing home care. Updated 11 March 2016. 
https://www.cdc.gov/nchs/fastats/nursing-home-care.htm. Accessed 1 June 2020. 
[CDC] Centers for Disease Control and Prevention. Older adults. Updated 30 April 2020. 
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html. 
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Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients 
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Health and Human Services. Table for Grading the Severity of Adult and Pediatric Adverse 
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FDA EUA fact sheet.  Fact sheet for health care providers, Emergency Use Authorization (EUA) 
of bamlanivimab. Available at: https://www.fda.gov/media/143603/download. Accessed: 16 
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[FDA] Food and Drug Administration. COVID-19: developing drugs and biological products for 
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Gottlieb RL, Nirula A, Chen P, et al. Effect of neutralizing monoclonal antibody bamlanivimab 
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Grabowski DC and Mor V. Nursing home care in crisis in the wake of COVID-19. [published 
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Graham NSN, Junghans C, Downes R, et al. SARS-CoV-2 infection, clinical features and 
outcome of COVID-19 in United Kingdom nursing homes [published online ahead of print, 
2020 Jun 3]. J Infect. 2020;S0163-4453(20)30348-0. https://doi.org/10.1016/j.jinf.2020.05.073
Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics.
1983; 39(2):499-503.
Werner RM, Hoffman AK, Coe MB. Long-term care policy after Covid-19 — solving the 
nursing home crisis. [Published online 27 May 2020]. NEJM.
https://doi.org/10.1056/NEJMp2014811

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