International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
Conditions: SARS-CoV Infection, Covid19
Sponsor: Certara

REGISTRY PROTOCOL 
Protocol Title: 
International Registry of Healthcare Workers 
Exposed to COVID-19 Patients (UNITY Global) 
Protocol Number: 
CER-HCW-001 
Protocol Version: 
Version 1.1 
Protocol Date: 
11 June 2021 
Sponsor: 
Certara Inc. 
Clinical Research 
Organization: 
Parexel International 

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SPONSOR 
Sponsor Contact Person: 
Roman Casciano 
Senior Vice President, Evidence and Access 
295 Madison Avenue, New York, NY 10017 
Telephone number: +1 (917) 369 0113 
Email: roman.casciano@certara.com

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SIGNATURE PAGE 
Declaration of Sponsor’s Responsible Person 
Title: International Registry of Healthcare Workers Exposed to COVID-19 Patients 
(UNITY Global)
This study protocol was subjected to critical review. The information it contains is 
consistent with the International Society for Pharmacoepidemiology Guidelines on Good 
Pharmacoepidemiology Practices. 
_____________________________________ 
_____________________ 
Name: Roman Casciano 
Date 
Title: Senior Vice President, Evidence and Access 
Institution: Certara, Inc. 
_____________________________________ 
_____________________ 
Name: Craig Rayner 
Date 
Title: President, Integrated Drug Development 
Institution: Certara, Inc. 

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Declaration of the Study Co-leads 
Title: International Registry of Healthcare Workers Exposed to COVID-19 Patients 
(UNITY Global)
All documentation for this study that is supplied to me and that has not been previously 
published will be kept in the strictest confidence. This documentation includes this study 
protocol and other scientific data. 
The study will not be commenced without the prior written approval of a properly 
constituted Institutional Review Board (IRB) or Independent Ethics Committee (IEC). 
No changes will be made to the study protocol without the prior written approval of the 
Sponsor. 
I have read and understood and agree to abide by all the conditions and instructions 
contained in this protocol. 
Responsible Study Co-lead 
_____________________________________ 
_____________________ 
Name: Roman Casciano 
Date 
Title: Senior Vice President, Evidence and Access 
Organization: Certara, Inc. 
Responsible Study Co-lead
_____________________________________     _____________________ 
Name: Craig Rayner                          Date 
Title: President, Integrated Drug Development 
Institution: Certara, Inc. 

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1
TABLE OF CONTENTS 
1
TABLE OF CONTENTS ............................................................................... 5
2
LIST OF ABBREVIATIONS ........................................................................ 7
3
RESPONSIBLE PARTIES ............................................................................ 8
4
ABSTRACT ..................................................................................................... 9
5
AMENDMENTS AND UPDATES .............................................................. 11
6
BACKGROUND AND RATIONALE ........................................................ 18
7
STUDY AIM AND OBJECTIVES .............................................................. 19
7.1
Primary Objective .................................................................................... 19
7.2
Secondary Objectives ............................................................................... 19
8
RESEARCH METHODS ............................................................................. 19
8.1
Study Design ............................................................................................. 19
8.1.1
Primary Outcome .......................................................................... 24
8.1.2
Secondary Outcomes .................................................................... 24
8.1.3
Rationale for the Study Design ..................................................... 24
8.2
Population and Setting ............................................................................. 24
8.2.1
Inclusion Criteria .......................................................................... 25
8.2.2
Exclusion Criteria ......................................................................... 25
8.2.3
Healthcare Worker Enrollment ..................................................... 26
8.2.4
Healthcare Worker Withdrawal .................................................... 26
8.2.5
Healthcare Worker Identification Numbers .................................. 26
8.3
Variables ................................................................................................... 27
8.3.1
Clinical Outcomes Variables ........................................................ 27
8.3.2
Prophylactic Treatment (Treatment Exposure) ............................. 27
8.3.3
History of Exposure to COVID-19 Patients ................................. 27
8.3.4
Personal Protective Equipment Use .............................................. 28
8.3.5
Other Covariates ........................................................................... 28
8.4
Data Sources ............................................................................................. 31
8.5
Study Size .................................................................................................. 31
8.6
Data Management .................................................................................... 31
8.6.1
Data Collection ............................................................................. 31
8.6.2
Archiving Study Records .............................................................. 32
8.7
Data Analysis ............................................................................................ 32
8.7.1
General Considerations ................................................................. 32
8.7.2
Analysis Population ...................................................................... 33
8.7.3
Descriptive Analyses .................................................................... 33
8.7.4
Primary Analysis ........................................................................... 33
8.7.5
Secondary Analyses ...................................................................... 34
8.7.6
Sensitivity Analyses ...................................................................... 34
8.7.7
Determination of Sample Size ...................................................... 34
8.8
Quality Control ......................................................................................... 35

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8.8.1
Data Quality Assurance ................................................................ 35
8.8.2
Access to Source Data .................................................................. 35
8.9
Limitations of the Research Methods ..................................................... 35
8.10
Other Aspects ........................................................................................... 36
8.10.1
Scientific Advisory Committee..................................................... 36
8.10.2
Transparency ................................................................................. 37
9
PROTECTION OF HUMAN SUBJECTS ................................................. 37
9.1
Good Pharmacoepidemiology Practices ................................................. 37
9.2
Electronic Informed Consent .................................................................. 37
9.3
Protocol Approval and Amendment ....................................................... 37
9.4
Confidentiality .......................................................................................... 37
9.5
Duration of the Study ............................................................................... 38
9.6
Premature Termination of the Study ..................................................... 38
10
MANAGEMENT AND REPORTING OF ADVERSE 
EVENTS/ADVERSE REACTIONS............................................................ 39
11
PLANS FOR DISSEMINATING AND COMMUNICATING STUDY 
RESULTS ...................................................................................................... 40
12
REFERENCES .............................................................................................. 41
Tables in Text 
Table 1
Schedule of Assessments – Healthcare Worker Flow ....................................................... 22
Table 2
Schedule of Assessments – Facility-Level ........................................................................ 23
Figures in Text 
Figure 1
Study Schematic - High-level ............................................................................................ 20
Figure 2
Study Schematic – Healthcare Worker Flow..................................................................... 21
List of Appendices 
Appendix 1: WHO Ordinal Scale for Clinical Improvement 9 .............................................................. 42
Appendix 2: Detailed SoA .................................................................................................................... 43
Appendix 3: List of Prophylactic Treatments ........................................................................................ 47

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2
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ACE 
Angiotensin-converting Enzyme 
AE 
Adverse Event 
ARB 
Angiotensin II Receptor Blockers  
BCG 
Bacillus Calmette–Guérin 
CoV 
Coronavirus 
COVID-19 
Coronavirus Disease 2019 
GPP 
Good Pharmacoepidemiology Practices 
HCW 
Healthcare Worker 
HIV 
Human Immunodeficiency Virus 
IEC 
Independent Ethics Committee 
ICU 
Intensive Care Unit 
IgG 
Immunoglobulin G 
IgM 
Immunoglobulin M 
IRB 
Institutional Review Board 
NSAIDs 
Nonsteroidal Anti-inflammatory Drugs 
PCR 
Polymerase Chain Reaction 
PPE 
Personal Protective Equipment 
SAC 
Scientific Advisory Committee 
SAP 
Statistical Analysis Plan 
SARS 
Severe Acute Respiratory Syndrome 
WHO 
World Health Organization 

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3
RESPONSIBLE PARTIES 
Sponsor 
Roman Casciano, 
Senior Vice President, Evidence and Access 
295 Madison Avenue, New York, NY 10017 
Telephone number: +1 (917) 369 0113 
Email: roman.casciano@certara.com
Craig R. Rayner, 
President, Integrated Drug Development, 
Certara Strategic Consulting, 
100 Overlook Center, Princeton, NJ 08540 
Telephone number: +1 (609) 955 4676 (US) 
Email: craig.rayner@certara.com
Contract Research 
Organization 
Parexel International 
2 Federal Street 
Billerica, MA, USA, 01821 

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4
ABSTRACT 
Protocol Title: 
International Registry of Healthcare Workers Exposed to COVID-19 
Patients (UNITY Global)
Protocol Number: 
CER-HCW-001 
Protocol Version: 
Version 1.1. 
Protocol Date: 
11 June 2021 
Author: 
To be confirmed. 
Sponsor: 
Certara, Inc 
Background: 
Healthcare workers (HCWs) are integral in providing clinical care to 
COVID-19 patients. Due to the highly infectious nature of the 
SARS-CoV-2 virus known to cause COVID-19, rigorous infection 
prevention and control measures in healthcare facilities are needed to limit 
nosocomial (healthcare-associated) infections among HCWs, and preserve 
the ability of the healthcare system to handle the patient caseload. Several 
medicines (e.g., hydroxychloroquine, lopinavir) have been proposed as 
potentially valuable prophylaxis to help reduce the risk of infection among 
HCWs and others, however, limited evidence of their effectiveness exists in 
this setting. 
Description: 
The International Registry of Healthcare Workers Exposed to COVID-19 
Patients (UNITY Global), is an international registry of approximately 
10,000 healthcare workers in low- and middle-income countries 
experiencing increasing numbers of COVID-19 cases and commensurate 
increased exposure to the SARS-CoV-2 virus among their healthcare 
worker populations. 
Aims and Objectives: 
The aim of this registry is to generate real-world evidence in HCWs to 
potentially inform recommendations and policies on prevention measures, 
including prophylactic use of potential drug therapies in HCWs. 
Primary Objective: 
To assess the association of potential prophylactic treatments with reduced 
risk of COVID-19 (or SARS-CoV-2 infection) in HCWs caring for 
COVID-19 patients. 
Secondary Objectives: 
To characterize the type of potential prophylactic treatments, by dose and 
duration, overall, and by country/region/site and to explore the key factors 
(for example, use of personal protective equipment (PPE), HCW and 
healthcare facility characteristics, underlying co-morbidities, household 
history and COVID-19 exposure) modifying the risk of COVID-19 among 
HCWs. 

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Registry Enrolees: 
The registry will enrol HCWs who are experiencing or are expected to 
experience ongoing and recurrent close contact with confirmed or clinically 
diagnosed COVID-19 patients. Recruitment for the registry will aim to 
enrol a representative distribution of HCWs on the front lines of diagnosing 
and caring for COVID-19 patients in both hospitals and community 
settings, as well as a balanced sample of HCWs receiving the most 
commonly administered putatively prophylactic drug regimens. 
Data Collection: 
The registry will collect information on a weekly basis from HCWs across 
a 12-week period following their first known exposure to confirmed or 
clinically diagnosed COVID-19 patients prior to or within 30 days after 
enrollment. Data collection will include the drug regimens being taken by 
the HCWs, information about their level of exposure to COVID-19 
patients, their personal health status, and other factors such as the use of 
PPE which would likely impact their risk of developing a SARS-CoV-2 
infection. 
Analyses: 
A standard pharmaco-epidemiological inferential analysis will be 
conducted treating the registry data as a cohort with dynamic exposure to 
both prophylactic treatment and to COVID-19 infected patients and 
adjusting for potential confounding. Crude and adjusted hazards ratios will 
be estimated for prophylactic regimens of interest and any observed impact 
on the risk of infection among HCWs based on all statistical inferential 
models will be reported. 

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AMENDMENTS AND UPDATES 
DOCUMENT HISTORY 
Document 
Protocol Version 
Date 
Amendment 1
1.1
11 June 2021
Original Protocol
1.0
08 June 2020
Amendment 1 (11 June 2021)
Overall rationale for the amendment: To adapt the protocol in accordance with the 
changing dynamics of the COVID-19 pandemic. 
Specific changes to the protocol include: 
LOCATION 
OF REVISION
DESCRIPTION OF REVISIONS
RATIONALE FOR REVISIONS
Background 
and Rationale: 
Section 6 
Previous text: 
None 
New text: 
Several medicines (e.g., 
hydroxychloroquine, lopinavir) have been 
proposed as potentially valuable prophylaxis 
to help reduce the risk of infection among 
HCWs and others, however, limited 
evidence of their effectiveness exists in this 
setting.
In order to standardize the text 
throughout the document.
Research 
Methods: 
Sections 8.1, 
8.2, 8.2.3, 8.3, 
8.3.5, 8.5, 8.7.4, 
8.9, and 8.10.1. 
8.1 Study Design 
Previous text: 
However, serology testing for SARS-CoV-2 
antibodies will be offered to the first 50% of 
participating HCWs per country, at 
enrollment and at the last follow-up (i.e. at 
Week 12). 
New text:
However, serology testing for SARS-CoV-2 
antibodies may be offered to approximately
50% of participating HCWs per country, at 
enrollment (ranging from baseline up to 
Week 4 [African countries] and Week 8 
[Pakistan]) and at the last follow-up (i.e. at 
Week 12). 
As a result of the 
COVID-19 
pandemic, the production of serology 
kits, and shipments to various countries 
were delayed. Additional COVID-19 
delays were caused by regulations at 
customs, as well as availability of kit 
content at wholesalers. 
The 
optional 
serology 
sample 
collection does not form part of the 
endpoints and objectives of the study. 
Due to logistical constraints mentioned 
above, serology was not offered to the 
first 50% of healthcare workers per 
country, but rather a compliment of 
50% of healthcare workers, upon kit 
availability. 
Within Pakistan, healthcare workers 
were offered serology, and were 
provided with testing kits, when the 
testing kits were available. It will 
therefore be allowed for the baseline 
sample to be collected from the 
following timepoints (ranging from 
baseline up to Week 8). 
Within 
the 
African 
continent, 
healthcare 
workers 
were 
offered 

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serology, and were provided with 
testing kits when the testing kits were 
available. It will therefore be allowed 
for the baseline sample to be collected 
from the following timepoints (ranging 
from baseline up to Week 4).
8.1 Study Design 
Previous text: 
Healthcare workers will be identified for 
participation via a central contact at 
participating healthcare facilities and directed 
to a website/mobile application allowing 
them to electronically consent and answer 
questions that would help assess their 
eligibility to participate. 
New text: 
Healthcare workers will be identified for 
participation via a central contact at 
participating healthcare facilities and directed 
to a website/mobile application allowing 
them to electronically consent (in parallel, 
paper consents may be used, as per local 
requirements) and answer questions that 
would help assess their eligibility to 
participate.
Updated section to incorporate local 
requirements of participating countries 
which was not known at the time of the 
initial protocol finalization. 
8.1 Table 1 Schedule of Assessments 
Previous text: 
None 
New text: 
COVID-19 vaccination 
Footnote e: From the time the questions on 
vaccination go live in the web application 
online survey, baseline vaccination 
information will only be collected for newly 
enrolled HCW and for HCWs who did not 
complete the survey prior to the addition of 
vaccination questions.
Footnote f: As a result of the COVID-19 
pandemic, the production of serology kits, 
and shipments to various countries were 
delayed. It will therefore be allowed for the 
To collect up-to-date information on 
prophylactic treatments available at 
the time of study. 
Footnote f: As a result of the 
COVID-19 pandemic, the production 
of serology kits, and shipments to 
various countries were delayed. 
Additional COVID-19 related delays 
were caused by regulations at 
customs, as well as availability of kit 
content at wholesalers. 

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baseline sample to be collected from the 
following timepoints (ranging from baseline 
up to Week 8). 
8.1 Table 1 Schedule of Assessments 
Previous text: 
Electronic consent 
New text: 
Electronic/paper (if applicable) consent 
Updated table to incorporate local 
requirements of participating countries 
which was not known at the time of 
the initial protocol finalization. 
8.2 Population and Setting 
Previous text: 
The study population comprises male and 
female HCWs, aged 18 years or older, 
working in healthcare facilities (e.g., acute 
care hospital) or in a community healthcare 
setting (e.g., clinic) in countries potentially 
to include Bangladesh, Ethiopia, Pakistan, 
Rwanda, South Africa, Zimbabwe and other 
countries depending on the status of the local 
COVID-19 epidemic, and the availability 
and usage patterns of potential prophylactic 
treatments. 
New text: 
The study population comprises male and 
female HCWs, aged 18 years or older, 
working in healthcare facilities (e.g., acute 
care hospital) or in a community healthcare 
setting (e.g., clinic) in the following 
countries: Indonesia, Kenya, Nigeria, 
Pakistan, Senegal, South Africa, Uganda, 
Zambia, and Zimbabwe. The countries 
were selected based on the status of the 
local COVID-19 epidemic, and the 
availability and usage patterns of potential 
prophylactic treatments. 
List of countries updated as per study 
feasibility assessments. 
8.2.3 Healthcare Worker Enrollment 
Previous text: 
Healthcare workers who agree to participate 
will be directed to a website/mobile 
application allowing them to electronically 
consent and confidentially complete 
questionnaires (the details and frequency of 
these questions are provided in Section 8.1). 
New text: 
Healthcare workers who agree to participate 
will be directed to a website/mobile 
application allowing them to electronically 
consent (in parallel, paper consents may 
be used, as per local requirements) and 
confidentially complete questionnaires (the 
details and frequency of these questions are 
provided in Section 8.1).
Updated table to incorporate local 
requirements of participating countries 
which was not known at the time of 
the initial protocol finalization. 

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8.2.3 Healthcare Worker Enrollment 
Previous text: 
For example, the registry will enroll 
approximately 75% of HCWs on a potential 
prophylactic therapy and approximately 
3-4% will be community HCWs as they are 
not typically represented in other registries. 
New text:
For example, the registry will enroll 
approximately 75% of HCWs on a potential 
prophylactic therapy. 
To remove restrictions on the 
enrollment of community HCWs. 
8.3 Variables 
Previous text: 
The sections below include outcomes, 
treatment exposure and PPE use, COVID-19 
exposure, and other variables to be measured 
and accounted for in the study analyses. 
New text:
The sections below include outcomes, 
treatment exposure and PPE use, COVID-19 
exposure, COVID-19 vaccinations, and 
other variables to be measured and 
accounted for in the study analyses. 
To collect up-to-date information on 
prophylactic treatments available at 
the time of study.  
8.3.5 Other Covariates 
Previous text: 
None 
New text: 
COVID-19 Vaccinations 
–
Convidicea (Ad5-nCoV) 
–
CoronaVac (Sinovac) 
–
Covaxin (BBV152) 
–
EpiVacCorona (Vector Institute) 
–
Janssen Pharmaceuticals (Johnson 
& Johnson) (Ad26.COV2.S) 
–
Moderna COVID-19 Vaccine 
–
Novavax (NVX-CoV2373) 
–
Oxford-AstraZeneca COVID-19 
Vaccine 
–
Pfizer-BioNTech COVID-19 
Vaccine 
–
Sinopharm BBIBP-CorV 
–
Sputnik V COVID-19 Vaccine 
–
Other (to be specified) 
To collect up-to-date information on 
prophylactic treatments available at 
the time of study. 
8.5 Study Size 
Previous text: 
At least 10,000 HCWs as determined by an 
expert panel, considering diversity of risk 
factors (e.g., healthcare system, geography, 
In order to standardize the text 
throughout the document.  

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interventions such as PPE and prophylactic 
therapies in use). 
New text: 
Approximately 10,000 HCWs as 
determined by an expert panel, considering 
diversity of risk factors (e.g., healthcare 
system, geography, interventions such as 
PPE and prophylactic therapies in use).
8.7.4 Primary Analysis 
Previous text: 
A standard pharmaco-epidemiological 
inferential analysis will be conducted 
treating the registry data as a cohort with 
dynamic exposure to both prophylactic 
treatment and to COVID-19 infected 
patients. 
Both crude and adjusted hazards ratios will 
be estimated. 
New text: 
A standard pharmaco-epidemiological 
inferential analysis will be conducted 
treating the registry data as a cohort with 
dynamic exposure to both prophylactic 
treatment and to COVID-19 infected patients 
and adjusting for potential confounding.
Both crude and adjusted hazards ratios will 
be estimated for prophylactic regimens of 
interest and any observed impact on the 
risk of infection among HCWs based on 
all statistical inferential models will be 
reported.
In order to standardize the text 
throughout the document. 
8.9 Limitations of the Research Methods 
Previous text: 
None 
New text: 
Since the data for this study are self-reported 
by HCWs who may not complete all 
surveys, this could lead to 
incomplete/missing data. In addition, there 
are possibilities of errors in recording 
information or missing information due to 
technical errors in the website/mobile 
application. To mitigate this risk, weekly 
SMS reminders and emails will be sent to 
HCWs. There is also an option of follow ups 
via phone call with HCWs as and when 
required.
To account for incomplete dataset and 
technical issues.  
8.10.1 Scientific Advisory Committee 
Previous text: 
The Scientific Advisory Committee will 
meet regularly throughout the study, and will 
focus on evaluating emerging evidence, 
Updated to clarify SAC requirements 

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providing “report to stakeholders”, “public 
data lens” and making recommendations 
including: 
New text: 
The Scientific Advisory Committee will 
focus on evaluating emerging evidence, 
providing “report to stakeholders”, “public 
data lens” and making recommendations 
including: 
Protection of 
Human 
Subjects: 
Section 9.2 
9.2 Electronic Informed Consent 
Previous text: 
Before each participant is admitted to the 
study, informed consent will be obtained 
electronically from the HCW according to 
the regulatory and legal requirements of the 
participating country. Record of this consent 
will be retained in the study database. 
New text: 
Before each participant is admitted to the 
study, informed consent will be obtained 
electronically from the HCW according to 
the regulatory and legal requirements of the 
participating country (in parallel, paper 
consents may be required in certain 
countries, e.g.,: Uganda and Zimbabwe 
according to local regulations.). Record of 
this consent will be retained in the study 
database (or country specific binders 
which will be archived at site according to 
local regulations).
Updated section to incorporate local 
requirements of participating countries 
which was not known at the time of 
the initial protocol finalization. 
Appendix 2
Detailed SOA 
Previous text: 
None 
New text: 
COVID-19 Vaccine, to be selected as 
applicable) 
  Convidicea (Ad5-nCoV) 
  CoronaVac (Sinovac) 
  Covaxin (BBV152) 
  EpiVacCorona (Vector Institute) 
  Janssen Pharmaceuticals (Johnson & 
Johnson) (Ad26.COV2.S) 
  Moderna COVID-19 Vaccine 
  Novavax (NVX-CoV2373) 
  Oxford-AstraZeneca COVID-19 Vaccine 
  Pfizer-BioNTech COVID-19 Vaccine 
  Sinopharm BBIBP-CorV 
  Sputnik V COVID-19 Vaccine 
  Other (to be specified) 
To collect up-to-date information on 
prophylactic treatments available at 
the time of study. 

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Previous text: 
Electronic consent 
New text: 
Electronic/Paper (if applicable) consent 
Updated section to incorporate local 
requirements of participating countries 
which was not known at the time of 
the initial protocol finalization. 
Throughout 
Minor, therefore have not been summarized. 
Minor updates for format and 
language as applicable were made 
throughout the protocol.  

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6
BACKGROUND AND RATIONALE 
Healthcare workers (HCWs) are integral in providing clinical care to COVID-19 patients. 
Due to the highly infectious nature of the SARS-CoV-2 virus known to cause COVID-19, 
rigorous infection prevention and control measures in healthcare facilities are needed in 
order to limit nosocomial (healthcare-associated) infections.1
In the context of the COVID-19 pandemic, healthcare workers are increasingly exposed 
directly to SARS-CoV-2-infected patients, sometimes without the appropriate level of 
personal protective equipment (PPE) and are at a high risk of nosocomial infection. As of 
08 April 2020, 22,073 HCWs from 52 countries were reported as severe acute respiratory 
syndrome 
(SARS)-coronavirus 
(CoV)-2 
positive.1
Several 
medicines 
(e.g., 
hydroxychloroquine, lopinavir) have been proposed as potentially valuable prophylaxis to 
help reduce the risk of infection among HCWs and others, however, limited evidence of 
their effectiveness exists in this setting. 
The China Center for Disease Control and Prevention indicated that 1,688 (3.8%) cases of 
the 44,672 confirmed SARS-CoV-2 positive cases occurred among HCWs.2 In Italy, 11% 
of 15,314 infections were reported in HCWs (as of 10 April 2020).3 Considering the 
different reporting practices across countries and the lack of systematic reporting of 
COVID-19 in HCWs to the World Health Organization (WHO), the prevalence of 
SARS-CoV-2 infection is likely underestimated globally.1 While the majority of 
COVID-19 cases in HCWs are reported as mild disease, severe outcomes, including deaths, 
have also been reported.4,5,6,7,8
Community-based approaches designed to minimize unnecessary contact between HCWs 
and febrile cases through home-based testing and follow-up can reduce the risk and burden 
on HCWs, especially in areas where viral febrile illnesses primarily circulate.12 In the 
current COVID-19 pandemic, especially in lower- and middle-income countries, 
community-based HCWs may be at the forefront of diagnosing and caring for COVID-19 
patients and experience substantial contact with potential SARS-CoV-2 infected people by 
the nature of their work. To our knowledge, these groups are likely to be underrepresented 
in the current ongoing research among HCWs, despite their importance to the public health 
infrastructure.13 
In addition to the potential harm SARS-Cov-2 infection may cause to HCWs, it will reduce 
healthcare capacity at a time when it will be overstretched by severe COVID-19 cases. In 
the context of the paradigm of “flattening the curve” to reduce peak infections to below the 
ceiling capacity of the healthcare system, infection of HCWs will lower the ceiling capacity 
making it less likely that systemically meaningful reductions can be achieved. 
Understanding infection in HCWs is fundamental to informing specific infection 
prevention and control measures needed to protect HCWs.1 Relatedly, characterizing the 
risk and the related risk factors in HCWs exposed to SARS-CoV-2, and quantifying the 
association of potential prophylactic treatments (medications or treatments designed and 
used to prevent occurrence of SARS-CoV-2 infection) with reduced risk of COVID-19 is 
a high priority globally. Several registries have been developed in the US and Europe, but 
low- and middle-income countries are underrepresented at this time.14

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An international registry of HCWs exposed to SARS-CoV-2 will provide fundamental 
information on the status and give an indication of the association of potential prophylactic 
and preventive measures. In addition, this registry could also be used to inform study 
rationales and designs for future research involving COVID-19 among HCWs. 
Furthermore, registry findings may also inform recommendations and policies on the 
prophylactic use of potential therapies in HCWs. 
7
STUDY AIM AND OBJECTIVES 
This is an international registry of HCWs exposed to SARS-CoV-2 while caring for 
confirmed or clinically diagnosed COVID-19 patients. The aim of this registry is to 
generate real-world evidence in HCWs to potentially inform recommendations and policies 
on prevention measures, including prophylactic use of potential drug therapies in HCWs. 
7.1
Primary Objective 

To assess the association of potential prophylactic treatments with reduced risk of 
COVID-19 (or SARS-CoV-2 infection) in HCWs caring for COVID-19 patients. 
7.2
Secondary Objectives 

To characterize the type of potential prophylactic treatments, by dose and duration, 
overall, and by country/region/site. 

To explore the key factors (for example, use of PPE, HCW and healthcare facility 
characteristics, underlying co-morbidities, household history and COVID-19 
exposure) modifying the risk of COVID-19 among HCWs.
8
RESEARCH METHODS 
8.1
Study Design 
The UNITY Global Registry is designed as a comparative cohort study using longitudinal 
serial surveys implemented through a web/mobile application-based technology to 
encourage participation and facilitate rapid responses during this pandemic. The study 
population comprises adult male and female HCWs working in healthcare facilities (e.g., 
acute care hospital) or in a community healthcare setting (e.g., clinic) with ongoing and 
continuous exposure to confirmed or clinically diagnosed COVID-19 patients. Countries 
and healthcare facilities will be selected based on the availability of potential prophylactic 
treatments to prevent workplace infection from SARS-CoV-2. The association of potential 
prophylactic treatments will be measured using the WHO Ordinal Scale of Clinical 
Improvement.9
Individuals with workplace exposure to confirmed or clinically diagnosed COVID-19 
patients prior to enrollment, or anticipated within 30 days after enrollment, will be eligible 
to participate. COVID-19 exposure is defined as per WHO classification.9 The date of the 
HCW’s first known exposure to a confirmed or clinically diagnosed case of COVID-19 is 
referred to as the “Index Date” (see Figure 2). Healthcare worker volunteers are ineligible 
if they had COVID-19 or symptoms highly suggestive of COVID-19 before the Index Date. 
However, at the time of enrollment, HCWs can be either SARS-CoV-2 positive 
(symptomatic or asymptomatic) or SARS-CoV-2 negative. 

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Healthcare workers will be identified for participation via a central contact at participating 
healthcare facilities and directed to a website/mobile application allowing them to 
electronically consent (in parallel, paper consents may be used, as per local requirements) 
and answer questions that would help assess their eligibility to participate. Information on 
potential prophylactic treatments used by HCWs will also be collected. The website/mobile 
application will prompt participants to provide entry-level information such as, 
demographics, underlying conditions, and exposure to COVID-19 patients. 
Healthcare workers will be expected to provide information on a weekly basis, for 
12 weeks after enrollment. In case HCWs stop responding (after due diligence reminders), 
their secondary contacts (identified by the HCW, may be next of kin or other individuals 
informed of HCW’s health status) will be approached. In case of conflicts, responses by 
HCWs will take precedence. 
Enrollment will be monitored and potentially capped to ensure that the study enrolls an 
aggregate of at least 75% of HCWs who are taking a potential prophylactic therapy. 
For details on the information collected and the overall study design, refer to Table 1, 
Table 2, Figure 1, and Figure 2, respectively. 
This is a comparative observational cohort study; therefore, no preventive interventions, 
visits or laboratory tests are mandated. Dosing and duration of potential prophylactic 
treatment is at the discretion of the institution and/or healthcare provider, in accordance 
with regular local practice. However, serology testing for SARS-CoV-2 antibodies may be 
offered to approximately 50% of participating HCWs per country, at enrollment (ranging 
from baseline up to Week 4 [African countries] and Week 8 [Pakistan]) and at the last 
follow-up (i.e. at Week 12). 
Figure 1 
Study Schematic - High-level 
HCW: Healthcare Worker 

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Figure 2 
Study Schematic – Healthcare Worker Flow 

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Table 1 
Schedule of Assessments – Healthcare Worker Flow 
Variable domain 
At Enrollment 
Weekly follow-up 
(until Week 12)c
HCW 
HCW 
Secondary 
Contact 
Inclusion/eligibility criteria (screening 
questions/index date)
X 
- 
- 
Electronic/paper (if applicable) consent
X
-
-
Demographics 
X 
- 
- 
Underlying conditions 
X 
- 
- 
Job characteristics
X
-
-
BCG vaccination history 
X 
- 
- 
Household history (COVID-19) 
X 
X 
- 
COVID-19 exposure
X
X
-
Prophylactic treatments 
X 
X 
- 
Concomitant medications 
X 
X 
- 
COVID-19 vaccinatione
X
X
PPE 
X 
X 
- 
COVID-19 symptoms 
X 
X 
- 
SARS-CoV-2 testing
X
X
-
Serology testing f
X 
Xb
WHO Ordinal Scale for Clinical Improvementd
X 
X 
Xa
BCG: Bacillus Calmette–Guérin; CoV: Coronavirus; HCW: Healthcare worker; PPE: Personal Protective Equipment; 
SARS: Severe acute respiratory syndrome; WHO: World Health Organization. 
a: In case HCWs stop responding (after due diligence reminders), their secondary contacts will be approached. In case of 
conflicts, responses by HCWs will be considered. 
b: Testing to be requested at last (Week 12) follow-up. 
c: Or, time since last follow-up, whichever is greater. 
d: Adapted, abbreviated version. 
e: From the time the questions on vaccination go live in the web application online survey, baseline vaccination 
information will only be collected for newly enrolled HCW and for HCWs who did not complete the survey prior to the 
addition of vaccination questions. 
f: As a result of the COVID-19 pandemic, the production of serology kits, and shipments to various countries were 
delayed. It will therefore be allowed for the baseline sample to be collected from the following timepoints (ranging from 
baseline up to Week 8).

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Table 2 
Schedule of Assessments – Facility-Level
Variable domain 
Prior to study 
End of study 
Country, region 
X 
- 
Urban or rural setting 
X 
- 
Type of facility (public/private/community healthcare)
X
-
Teaching/university hospital or non-teaching 
X 
- 
Capacity 
number of patients tested for COVID-19
X
X
number of COVID-19 patients treated 
X 
X 
number of hospital beds (overall, ICU, emergency department) 
X 
X 
number of exposed HCWs
X
X
number of HCWs tested for COVID-19 
X 
X 
Number of HCWs who developed confirmed or clinically 
diagnosed COVID-19
X 
X 
Number of HCWs who died from COVID-19 
X 
X 
Approved PPE use policy, and experience of PPE shortage 
X 
X 
Approved prophylactic treatment policy
X
X
Shortage of COVID-19 related tests 
X 
X 
BCG vaccination policy 
X 
X 
HCW: Healthcare worker; PPE: Personal Protective Equipment; BCG: Bacillus Calmette–Guérin. 

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8.1.1
Primary Outcome 

Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 
patients, in terms of time, geography, healthcare setting, type of HCW. 
8.1.2
Secondary Outcomes 

Occurrence of SARS-CoV-2 uninfected HCWs. 

Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of 
activities. 

Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of 
activities. 

Occurrence of hospitalization due to COVID-19 illness with mild disease. 

Occurrence of hospitalization due to COVID-19 illness with severe disease. 

Occurrence of all-cause mortality. 

Type of prophylactic treatments by dose, frequency and duration, overall and by 
country/region/site. 
8.1.3
Rationale for the Study Design 
The disease landscape of COVID-19 is rapidly evolving. There is, however, a lack of data 
about the rate of infection in HCWs given the exposure to COVID-19 patients and the 
association of potential prophylactic treatments used by HCWs. A global registry 
comprising HCWs caring for COVID-19 patients will therefore be instrumental to generate 
real-world evidence to inform further studies involving characterization of PPE and 
potential prophylactic treatments and the risk of SARS-CoV-2 infection among HCWs. 
The primary analyses in this registry are aimed at assessing the use and association of 
potential prophylactic treatments with COVID-19 in HCWs. The secondary analyses will 
explore potential risk factors for infection and other factors that may affect its association 
with potential prophylactic treatment therapies. 
8.2
Population and Setting 
The study population comprises male and female HCWs, aged 18 years or older, working 
in healthcare facilities (e.g., acute care hospital) or in a community healthcare setting (e.g., 
clinic) in the following countries: Indonesia, Kenya, Nigeria, Pakistan, Senegal, South 
Africa, Uganda, Zambia, and Zimbabwe. The countries were selected based on the status 
of the local COVID-19 epidemic, and the availability and usage patterns of potential 
prophylactic treatments. 
Hospitals or healthcare facilities directly participating in the study in target countries of 
interest should have at least five COVID-19 cases at the time of establishing the registry. 
Institutions that participate in the study should be able to provide a list of HCWs exposed 
to COVID-19 patients. 
As per the WHO definition10, HCWs eligible for enrollment are limited, based on the high 
likelihood of being exposed to COVID-19 patients during patient care, to the following 
positions: 

Medical doctors*

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
Clinical officers*

Licensed physician assistant or nurse practitioner*

Registered nurse (or equivalent)*

Assistant nurse, nurse technician (or equivalent)*

Phlebotomist 

Clinical pharmacist 

Clinical physical therapist 

Respiratory therapist 

Community healthcare worker 
*These should include the following primary specialties: 

Surgery (all sub-specialties) 

Internal medicine (general) 

Pulmonology/critical care 

Emergency medicine 

Geriatrics 

Cardiology 

Infectious disease 

Anesthesiology 

Pediatrics 

Obstetrics/Midwifery 

Other 
8.2.1
Inclusion Criteria 
Healthcare workers will be entered into this study only if they meet ALL the following 
criteria: 

Healthcare workers aged ≥ 18 years. 

Healthcare workers must be exposed through ongoing and recurrent contact to a 
confirmed or clinically diagnosed COVID-19 patient prior to enrollment, or 
anticipated within 30 days after enrollment. 

Healthcare workers must consent to provide data for the registry and must be 
willing to be contacted/reminded about data entry at each follow-up time point. 

Healthcare workers must agree to provide a secondary contact for follow-up. 
8.2.2
Exclusion Criteria 

 A confirmed SARS-CoV-2 infection or clinically diagnosed COVID-19 prior to 
the first known exposure to confirmed or clinically diagnosed COVID-19 patient 
(Index Date). 

Participation in a ‘blinded’ clinical trial, i.e., unaware of exact treatment received 
as part of the clinical trial. 

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8.2.3
Healthcare Worker Enrollment 
Healthcare workers from participating healthcare facilities and clinics will be recruited 
through a centralized effort within each facility/clinic. Healthcare workers who agree to 
participate will be directed to a website/mobile application allowing them to electronically 
consent (in parallel, paper consents may be used, as per local requirements) and 
confidentially complete questionnaires (the details and frequency of these questions are 
provided in Section 8.1). 
Enrollment will be continuously monitored and potentially capped to ensure that the study 
proportionately enrolls HCWs according to country, type of HCW and status of 
prophylaxis. For example, the registry will enroll approximately 75% of HCWs on a 
potential prophylactic therapy. 
This registry will remain open and will continue to enroll HCWs for as long as the 
pandemic continues regionally, or until otherwise determined by the Sponsor. 
8.2.4
Healthcare Worker Withdrawal 
HCWs may withdraw from the study (i.e., withdraw their consent) at any time. 
HCWs may be required to withdraw at the discretion of the Sponsor in case of incorrect 
self-enrollment (failure to meet inclusion/exclusion criteria). 
In the case of an HCW withdrawing consent through the study registry web form, the entry 
is recorded in the system. If the Sponsor and study team decide to withdraw the HCW, then 
they will track that decision in a study log that would be uploaded to the reporting database 
for analysis.
8.2.5
Healthcare Worker Identification Numbers 
Participant identification numbers will be randomly generated 32-digit alphanumeric 
characters used to key code the patients into the Central Data Store for analysis. 

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8.3
Variables 
The sections below include outcomes, treatment exposure and PPE use, COVID-19 
exposure, COVID-19 vaccinations, and other variables to be measured and accounted for 
in the study analyses. Refer to Appendix 2 for further details. 
8.3.1
Clinical Outcomes Variables 

WHO Ordinal Scale for Clinical Improvement of COVID-19 (adapted, 
abbreviated version) 
o
SARS-CoV-2 (uninfected/infected) 
o
Ambulatory status (limitation/no limitation of activities) 
o
Hospitalized with no intensive care unit (ICU) or mechanical 
ventilation (mild) 
o
Hospitalized with ICU and/or mechanical ventilation (severe) 
o
Death 
8.3.2
Prophylactic Treatment (Treatment Exposure) 

Types, intake frequency, and doses of prophylactic treatments 
o
Treatment name 
o
Date started 
o
Date stopped 
o
Dose (intake) 
o
Duration of treatment 
o
Dose frequency and dosing interval 
o
Status (stopped/ongoing) 
o
Reason for stopping (not available/side effects/expense/other) 
o
Number of missed doses and reason (not available/side 
effects/expense/other)
8.3.3
History of Exposure to COVID-19 Patients 

At enrollment 
o
Self-reported ongoing and recurrent exposure (yes/no) 
o
WHO exposure definition (3 questions) (yes/no) 
–
Direct patient care (yes/no) 
–
Face-to-face contact (yes/no) 
–
Present during aerosol-generating procedure (yes/no) 

Weekly follow-up 
o
Self-reported ongoing and recurrent exposure (yes/no) 
o
WHO exposure definition (3 questions) for past week 

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o
Days worked past week 
o
Number of COVID-19 cases exposed to in the past week 
8.3.4
Personal Protective Equipment Use 

At enrollment 
o
Type and use of PPE prior to enrollment 

Weekly follow-up 
o
Type and use of PPE at time of confirmed exposure(s) in the past week 
o
Number of COVID-19 exposures in the absence of a mask 
o
Longest COVID-19 exposure in the absence of a mask 
8.3.5
Other Covariates 

COVID-19 symptoms (and date the symptoms begin) 
o
Fever (temperature over 38℃) 
o
Subjective fever (felt feverish) 
o
Chills 
o
Myalgia (muscles hurt or ache) 
o
Rhinorrhea (runny or drippy nose) 
o
Pharyngitis (sore throat) 
o
Cough (new onset or worsening of chronic cough) 
o
Dyspnea (hard to breathe or difficulty breathing) 
o
Pneumonia 
o
Nausea or vomiting 
o
Headache or migraine 
o
Abdominal pain (pain in tummy) 
o
Asthenia (weakness or loss of strength) 
o
Arthralgia (joint pain) 
o
Anosmia (loss of smell) 
o
Ageusia (loss of taste) 
o
Blue coloring in toes 
o
Diarrhea (two or more looser-than-normal stools in 24 hours) 

SARS-CoV-2 testing 
o
Type of test, if known 
–
PCR (positive/negative) 
–
Antigen test (positive/negative) 
–
Serology (immunoglobulin G [IgG] and/or immunoglobulin M 
[IgM], positive/negative or titer) 
o
Date of test

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
Household history (COVID-19) 
o
Number of household contacts 
o
Additional household member(s) exposed to COVID-19 (yes/no). If 
yes, how many? 
o
Additional household member(s) with symptoms consistent with 
COVID-19 (yes/no). If yes, how many? 
o
Additional household member(s) diagnosed with COVID-19 (yes/no). 
If yes, how many? 

Healthcare worker-level covariates 
o
Demographics at entry 
o
Underlying conditions and key co-morbidities 
o
Job characteristics 
o
Concomitant medications 
o
Blood type 

Healthcare facility characteristics 
o
Country, region 
o
Urban or rural setting 
o
Type of facility (public/private/community healthcare) 
o
Teaching/university hospital or non-teaching 
o
Capacity 
–
number of patients tested for COVID-19 
–
number of COVID-19 patients treated 
–
number of hospitalized beds (overall, ICU, emergency department) 
–
number of exposed HCWs 
–
number of HCWs tested for COVID-19 
o
Number of HCWs who developed confirmed or clinically diagnosed 
COVID-19 
o
Number of HCWs who died from COVID-19 
o
Approved PPE use policy, and experience of PPE shortage 
o
Approved prophylactic treatment policy 
o
Shortage of COVID-19 related tests 
o
BCG vaccination policy 

Concomitant medications (other than for COVID-19) 
o
Antibiotics (yes/no). If yes, please specify. 
–
Azithromycin 
–
Trimethoprim/sulphamethoxazole 
–
Macrolide antibiotics (roxithromycin, clarithromycin, 
erythromycin) 

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–
Other antibiotics 
o
Antimalarials (yes/no). If yes, please specify. 
–
Hydroxychloroquine 
–
Chloroquine 
–
Sulfadoxine-pyrimethamine (SP) 
–
Other antimalarials 
o
Antiparasitics (yes/no). If yes, please specify. 
–
Ivermectin (yes/no) 
–
Other antiparasitics. 
o
Antiretrovirals for Human Immunodeficiency Virus (HIV) (yes/no). If 
yes, please specify. 
–
Lopinavir 
–
Ritonavir 
–
Tenofovir 
–
Nelfinavir 
–
Other antiretrovirals 
o
Antivirals (yes/no). If yes, please specify. 
–
Oseltamivir 
–
Favipiravir 
–
Arbidol 
–
Anti-hepatitis C treatments 
–
Remdesevir 
–
Other antivirals 
o
Medication for high blood pressure and cardiovascular disease 
(yes/no). If yes, please specify. 
–
Angiotensin-converting enzyme (ACE) inhibitor (e.g., 
lisinopril, enalapril) 
–
Angiotensin II receptor blockers (ARB) inhibitor (e.g., 
losartan, irbesarten) 
–
Other anti-hypertensive for high blood pressure 
–
Other medicine for high blood pressure and cardiovascular 
disease (e.g., antiarrhythmics, inotropes, chronotropes) 
o
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) e.g., Aspirin, 
Ibuprofen, Indomethacin, Celecoxib, Diclofenac (yes/no). If yes, 
please specify. 
o
Botanicals (yes/no) 
–
Artemisia teas (COVID Organics) 
o
Immunocompromising drugs (yes/no). If yes, please specify. 
–
Corticosteroids 
–
Cancer chemotherapy 

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–
Cyclosporine 
–
Drugs for autoimmune conditions such as lupus or rheumatoid 
arthritis, Crohn's disease 
o
Changes in concomitant medications. 

COVID-19 vaccinations 
o
Convidicea (Ad5-nCoV) 
o
CoronaVac (Sinovac) 
o
Covaxin (BBV152) 
o
EpiVacCorona (Vector Institute) 
o
Janssen Pharmaceuticals (Johnson & Johnson) (Ad26.COV2.S) 
o
Moderna COVID-19 Vaccine 
o
Novavax (NVX-CoV2373) 
o
Oxford-AstraZeneca COVID-19 Vaccine 
o
Pfizer-BioNTech COVID-19 Vaccine 
o
Sinopharm BBIBP-CorV 
o
Sputnik V COVID-19 Vaccine 
o
Other (to be specified) 
8.4
 Data Sources 
Primary data sources consist only of HCW-reported clinical information, obtained from 
HCWs completing an electronic data collection form. Secondary information from sites 
can be loaded to the Data Store for site time variable information, serology results, and 
HCW secondary point of contact feedback to the study team. 
8.5
Study Size 
Approximately 10,000 HCWs as determined by an expert panel, considering diversity of 
risk factors (e.g., healthcare system, geography, interventions such as PPE and prophylactic 
therapies in use). 
8.6
Data Management 
8.6.1
Data Collection 
All eligible HCWs in the study facilities will be asked to enter the data in the registry via 
electronic data collection form. 
Data will be collected at entry to the registry, and then weekly until 12 weeks after 
enrollment, death or lost to follow-up, whichever is earlier. 
A secondary contact should be identified to be contacted to confirm status of HCWs in case 
of non-response/loss to follow-up. 
Serology results from the laboratory will be loaded into the Local Data Store and merged 
with HCW contact information based on the participant identification numbers. 
Notification of results may be sent to the HCWs over secure link. 
Data security and privacy is a key part of the application design: 

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
The Application has received a full penetration test from an accredited third 
party to cover cyber security threats. 

Data is segregated between the collection nodes and analysis nodes. Only 
information technology support staff have access to the data in the nodes for 
the express purposes of server support. 

All data on the analysis platform is tokenized with a unique patient token 
generated on the node. This tokenization uses a powerful salted hash algorithm 
(a document explaining this process may be reviewed if necessary but cannot 
be released for security reasons). 

Access to the data platform is controlled by Azure Active Directory accounts 
managed by the Parexel Support team. 

Access to the Application can only be achieved by end user registration using a 
set of industry leading authentication providers. 

The application has a unidirectional data flow from the node to the analysis 
platform so there is no risk of horizontal escalation issues. 
A logical model of the data from the Central Data Store will be created in Microsoft Power 
BI to allow the study team to create dashboards and run global analysis on the 
de-personalized data. Additional tables can be added for Site data, Site timestamped 
variable records, secondary point of contact feedback to the Data Store to enable 
longitudinal analysis of co-variants 
8.6.2
Archiving Study Records 
According to International Society for Pharmacoepidemiology Guidelines on Good 
Pharmacoepidemiology Practices (GPP), the study archive will be maintained for at least 
5 years after final report or first publication of study results, whichever comes later. 
8.7
Data Analysis 
A separate statistical analysis plan (SAP) will be produced, providing detailed methods for 
the analyses outlined below. 
Any deviations from the planned analyses will be described and justified in the final study 
report.
8.7.1
General Considerations 
A number of key variables will be defined within the SAP, based on the data depth actually 
collected and on inputs from the Scientific Advisory Committee (SAC) members and from 
the local clinical experts. Those variables include e.g.,: 

Outcomes variables (confirmed versus clinically diagnosed). 

Variables defining intensity of exposure to COVID-19 infected patients over time. 

Variables defining exposure to potential prophylactic treatments imputable to a 
given outcome (e.g., cumulative or not, AUCs or dose over time, lagged effect). 

Switching or treatment interruption events. 
Subpopulations to consider will also be discussed and detailed in the SAP. 
Most analyses will be conducted using SAS or R software packages. 

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8.7.2
Analysis Population 
The total pooled study population from all facilities will form the primary population for 
analysis. 
Subgroup, stratified, and sensitivity analyses will also be defined in the SAP. 
8.7.3
Descriptive Analyses 
Prior to implementing the analysis to address the primary objectives of the study, 
descriptive analyses will be carried out to understand the main features and patterns in the 
population and in the data collected. 
Crude numbers for each outcome will be displayed over time and as cumulative risks. 
Study population characteristics will first be tabulated at index date and over time. 
Likewise, variables measuring exposure to potential prophylactic treatment and to 
COVID-19 patients over time. 
Continuous variables over time will be described using summary statistics including mean, 
median, minimum and maximum, as well as box plots. Scores distribution over time will 
be displayed and Kaplan-Meier estimates will be calculated, and curves be plotted for each 
time-to-event outcome. 
The observed incidence weekly rates of PCR-confirmed symptomatic COVID-19 and of 
COVID-19-related hospitalizations and deaths will be tabulated over weeks by facilities 
and compared according to prophylactic exposure in the study or against comparative 
controls. 
Applications of estimated propensity scores will be employed to explore differences 
between HCWs’ profiles exposed versus non-exposed to potential prophylactic treatments. 
Estimated propensity score distributions will be displayed over weeks and a concordance 
analysis performed to detect any trend over time. 
Stratified pooled analyses at country level will also be displayed. 
8.7.4
Primary Analysis 
A standard pharmaco-epidemiological inferential analysis will be conducted treating the 
registry data as a cohort with dynamic exposure to both prophylactic treatment and to 
COVID-19 infected patients and adjusting for potential confounding. 
Both crude and adjusted hazards ratios will be estimated for prophylactic regimens of 
interest and any observed impact on the risk of infection among HCWs based on all 
statistical inferential models will be reported. 
Outcomes will be adjudicated to exposure time based on prior decision rules agreed with 
the SAC. Hazards for each subject-week will be compared and adjusted for exposure to 
prophylaxis over time, exposure to COVID-19 positive patients over time and to other 
covariates, accounting for subject-level clusters. Repeated time-to-event analyses with 
competing risk will be carried out. 
Handling of missing data and unexplained drop-outs will be discussed with the SAC. 
Interaction terms to be considered will also be discussed with the SAC and clinicians. 

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Matching or other balancing methods such as estimated propensity score matching, inverse 
probability weighting or marginal structural methods, or alternative methods, will be 
considered to potentially address the identified biases and allow for evaluation of 
association. 
In case the number of infection cases is lower than anticipated to allow for such analyses, 
matched case-control analyses will also be considered. 
8.7.5
Secondary Analyses 
All time-to-event secondary analyses will be conducted similar to the primary analysis. 
They include: 

Time to clinical events (each defined by the WHO severity score or proxies to be 
defined). 

Time to switch or prophylaxis interruption. 
Other derived variables such as time in hospitalization will be analyzed via generalized 
mixed effect models. 
8.7.6
Sensitivity Analyses 
Among the sensitivity analyses, the adjusted analyses of the primary outcome will be 
replicated: 

According to the subgroup of HCWs for which PCR-confirmed absence of 
infection at index date is demonstrated. 

According to the subgroup of HCWs for which serology results are available at 
entry and follow-up. 

Using the infection status and timing as self-reported only. 

Imputing unexplained drop-outs as events. 

According to the time from index date to entry in the registry date. 
As part of a risk mitigation plan and for further insights generation, e.g., in the case of low 
number of events or unexpectedly low exposure to potential prophylactic treatments, 
alternative approaches will be considered to maximize the power and enhance the 
robustness of the proposed study. In this case, additional information e.g., from published 
local data could be leveraged using Bayesian modelling approach on the incidence 
dynamics modelling and association analyses, together with impact assessments. 
8.7.7
Determination of Sample Size 
The targeted sample size of approximately 10,000 HCWs assumes that 20% of the study 
population are non-exposed to potential prophylactic treatments, with a baseline risk of 
SARS-CoV-2 infection in the study period of 10% (for unexposed: not treated with 
potential prophylactic treatment). A total of N=10,000 allows for 80% power to identify an 
effect size of Relative Risk = 0.78. 

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8.8
Quality Control 
8.8.1
Data Quality Assurance 
The participants themselves will directly enter all study data on electronic web data entry 
form in a secure registry system. To the best of the Sponsor’s ability, data logic and 
validation checks will be configured in the platform so that participants will receive 
warning messages at time of entry of inconsistent or invalid entries, in order to ensure 
quality and completeness of data. 
After verification of eligibility and study enrollment, the self-reported data will not be 
queried for clarification or correction by the Sponsor after a participant’s submission of the 
electronic web data form into the registry. 
8.8.2
Access to Source Data 
All data for this study are self-reported by the HCW and collected via the website/mobile 
application, and therefore there will be no source documents for monitoring. 
8.9
Limitations of the Research Methods 
As this is an observational study based on self-reported information from HCWs, there are 
several potential limitations and biases, as follows: 

Selection bias, either in the selection of sites/participants for the study (primarily 
affecting the external validity of the study) or treatment selection (i.e., 
non-randomized treatment selection affecting primarily internal validity). To 
minimize the impact of selection bias in the selection of participants, in each 
healthcare facility, the list of exposed HCWs will be obtained and all eligible 
HCWs will be offered enrollment. 

The inability to conduct probability sampling of sites/participants within sites will 
diminish the ability to generalize the findings from the study sample to the HCW 
population of inference. 

Survival bias may occur if eligible HCWs who developed COVID-19 were less or 
more likely to participate in the registry, or with inability of the registry to capture 
HCWs who died from COVID-19. This may lead to under- or over-estimation of 
the risk of COVID-19 based on the use of prophylactic treatment. To assess the 
impact of this bias, a metadata of healthcare facility-level variables will be collected 
at time of the registry establishment and at the end of the study, including number 
of exposed to COVID-19 HCWs, number of HCWs who developed COVID-19 and 
who died from COVID-19 at each participating healthcare facility. 

Similar bias may occur in case of differential lost to follow-up of HCWs based on 
COVID-19 status during follow-up. The inclusion of secondary contacts will allow 
to at least partially address the impact of this bias. Also, the proportion of HCWs 
lost to follow-up, including based on their risk profile and the use of prophylactic 
treatment, will be described. 

This study also allows for the enrollment of HCWs who have had a recent infection 
with recovery or ongoing symptoms at the time of enrollment, and HCWs without 
such a history and who are asymptomatic at the time of enrollment. While this 
approach facilitates faster enrollment and/or a greater number of HCWs to be 

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enrolled, a form of systematic measurement error called recall bias may result from 
an attempt to collect data retrospectively from those with a recent history of 
COVID-19. However, this potential source of bias will be assessed based on 
evaluations of facility-level data and stratified assessments of HCWs according to 
their index date (i.e., duration from the first known exposure to COVID-19 patients 
to the date of enrollment). 

All information is self-reported, and there is no mechanism to verify the accuracy 
of information entered into the web-application. Relatedly, the reporting of 
outcomes of hospitalization and death are dependent on the reliable participation of 
a secondary contact, who may be difficult to contact in the case of an HCW’s death. 

Association of compared therapies may be confounded by non-random treatment 
selection/allocation that may have its provenance in unknown mechanisms 
associated with confounding by indication and channeling bias, among others. 
These may at least, in part, be addressed through the use of causal graphical models 
in association with appropriate statistical cohort balancing techniques, such as 
propensity score analysis and matching, and inverse probability weighted 
estimators, to be detailed in the SAP. 

The study may also be affected by protopathic bias in which the timing of, for 
example, formal diagnosis with regard to when symptoms and treatment occurs can 
result in incorrect causal inference regarding the effect of the treatment exposure 
on the risk of the outcome. A common general example is when patients are 
prescribed a drug to address disease symptoms ahead of the formal diagnosis of the 
disease which can lead one to incorrect inference regarding the effect of the 
treatment. Sensitivity analyses will be conducted among the subgroup of HCWs for 
which PCR-confirmed absence of infection at index date is demonstrated, and 
according to the subgroup of HCWs for which serology results are available. 

Since the data for this study are self-reported by HCWs who may not complete all 
surveys, this could lead to incomplete/missing data. In addition, there are 
possibilities of errors in recording information or missing information due to 
technical errors in the website/mobile application. To mitigate this risk, weekly 
SMS reminders and emails will be sent to HCWs. There is also an option of 
follow-ups via phone call with HCWs as and when required. 
8.10 Other Aspects 
8.10.1 Scientific Advisory Committee 
A SAC will act in an advisory capacity to the Sponsor to provide guidance to the study 
design, conduct, analysis methodology and to support its successful completion. The 
Scientific Advisory Committee will focus on evaluating emerging evidence, providing 
“report to stakeholders”, “public data lens” and making recommendations including: 

Strategies to optimize data collection, recruitment of HCW populations and potential 
real-world prophylactic therapies. 

Signals to escalate (association, safety, sub-population issues). 

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8.10.2 Transparency 
To facilitate updates on study progress, SAC endorsed summary level and de-identified 
data evolving from the progress of the UNITY Global Registry will be communicated 
intermittenly on COVIDpharmacology.com. 
9
PROTECTION OF HUMAN SUBJECTS 
9.1
Good Pharmacoepidemiology Practices 
The procedures set out in this study protocol are designed to ensure that the Sponsor and 
Study Lead abide by the principles of the International Society for Pharmacoepidemiology 
GPP guidelines.11 The study also will be carried out in keeping with local legal 
requirements.
9.2
Electronic Informed Consent 
Before each participant is admitted to the study, informed consent will be obtained 
electronically from the HCW according to the regulatory and legal requirements of the 
participating country (in parallel, paper consents may be required in certain countries, e.g.,: 
Uganda and Zimbabwe according to local regulations.). Record of this consent will be 
retained in the study database (or country specific binders which will be archived at site 
according to local regulations). 
If a protocol amendment is required, the informed consent form may need to be revised to 
reflect the changes to the protocol. If the consent form is revised, it must be reviewed and 
approved by the appropriate Institutional Review Board/Independent Ethics Committee 
(IRB/IEC), and signed by all participants subsequently enrolled in the study as well as 
those currently enrolled in the study. 
9.3
Protocol Approval and Amendment 
Before the start of the study, the study protocol and/or other relevant documents will be 
approved by the IRB/IEC/Competent Authorities, in accordance with local legal 
requirements. The Sponsor must ensure that all ethical and legal requirements have been 
met before the first participant is enrolled in the study. 
To alter the protocol, amendments must be written, receive approval from the appropriate 
personnel, and receive IRB/IEC/Competent Authority approval prior to implementation (if 
appropriate). 
Administrative changes (not affecting participant risk) may be made without the need for 
a formal amendment. All amendments will be distributed to all protocol recipients, with 
appropriate instructions. 
9.4
Confidentiality 
All study findings and documents will be regarded as confidential. The Study Lead and 
members of his/her research team must not disclose such information without prior written 
approval from the Sponsor. 
The anonymity of participants must be maintained. Study Leads shall ensure that personal 
identifiers will be removed from any study files that are accessible to non-study personnel 
in accordance with applicable laws and regulations. Participants will be identified in 
documents submitted to Parexel by their identification number, initials and/or birth date, 

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not by name. Documents not to be submitted to Parexel that identify the participant (e.g., 
the signed informed consent) must be maintained in confidence by the Study Lead. 
9.5
Duration of the Study 
The registry will remain open in different regions of the world for as long as the pandemic 
continues regionally. 
For an individual participant, the maximum duration of participation in the study will be 
up to 12 weeks. 
The entire study will end 12 weeks after the last-participant-in date. 
9.6
Premature Termination of the Study 
The study may be terminated early at the Sponsor’s discretion. Conditions that may warrant 
termination include: 

Failure to enroll participants at an acceptable rate. 

A decision on the part of the Sponsor to suspend the study for administrative reasons. 

Ethical reasons. 

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10
MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS 
No AEs/adverse reactions will be collected during this study. 
There are no physical risks to the participants in the study given the observational nature 
of the study design, apart from the minimal risk for obtaining blood/serology for 
SARS-COV-2 testing. A key risk to participants is a potential breach of confidentiality of 
the medical record information and the associated privacy. However, this risk is 
mitigated due to the data privacy measures incorporated in the web application system to 
key code participant data on the central reporting database accessible by the study team for 
data analysis. 
If any unanticipated problems related to the study involving risks to participants or others 
happen during the course of this study, these will be reported to the IRB/IEC in accordance 
with all applicable IRB/IEC, local, and regulatory requirements. Any participant who 
believes 
that 
a 
serious 
risk 
may 
be 
associated 
with 
exposure 
to 
any 
prophylactic/concomitant treatment during the course of this study must report the AE to 
the manufacturer of the treatment, in accordance with applicable regulatory requirements. 
Unanticipated problems that do not involve risks to participants or others will be 
summarized in narrative or other format and submitted to the IRB/IEC at the time of 
continuing review, if required. 

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11
PLANS FOR DISSEMINATING AND COMMUNICATING STUDY 
RESULTS 
Near real-time descriptive analytics dashboard will be made available in a continuous 
manner to provide a high-level view of pre-defined study variables/data. Additionally, 
emerging data on COVID-19 will be publicly shared, as appropriate. 
The study findings may be disseminated if they are found to be of scientific or public health 
importance. Study results may be included in abstracts sent to scientific congresses. 
Specific plans for disseminating and communicating the study results will be produced 
when the results are available. 

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12
REFERENCES 
1. https://www.who.int/docs/default-source/coronaviruse/situation-
reports/20200411-sitrep-82-covid-19.pdf?sfvrsn=74a5d15_2. Last accessed on 
14 Apr 2020.
2. The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. 
The epidemiological characteristics of an outbreak of 2019 Novel Coronavirus 
Diseases (COVID-19) – China, 2020. 
http://weekly.chinacdc.cn/en/article/id/e53946e2-c6c4-41e9-9a9b-
fea8db1a8f51. Last Accessed on 14 Apr 2020. 
3. Integrated surveillance of COVID-19 in Italy: 10 April 2020. 
https://www.epicentro.iss.it/en/coronavirus/bollettino/Infografica_10aprile%20
ENG.pdf. Last accessed on 14 Apr 2020. 
4. Kluytmans M, Buiting A, Pas S, et al. SARS-CoV-2 infection in 86 healthcare 
workers in two Dutch hospitals in March 2020. medRxiv. 2020. 
5. Liu M, He P, Liu HG, et al. Clinical characteristics of 30 medical workers 
infected with new coronavirus pneumonia. Zhonghua Jie He He Hu Xi Za Zhi; 
2020;43(3):209-214. 
6. Liu J, Ouyang L, Guo P, et al. Epidemiological, Clinical Characteristics and 
Outcome of Medical Staff Infected with COVID-19 in Wuhan, China: A 
Retrospective Case Series Analysis. medRxiv. 2020. 
7. McMichael TM, Currie DW, Clark S, et al. Epidemiology of Covid-19 in a 
Long-Term Care Facility in King County, Washington. N Engl J Med. 2020. 
8. Wang C, Liu L, Hao X, et al. Evolving Epidemiology and Impact of Non-
pharmaceutical Interventions on the Outbreak of Coronavirus Disease 2019 in 
Wuhan, China. medRxiv. 2020. 
9. COVID-19 Therapeutic Trial Synopsis. https://www.who.int/blueprint/priority-
diseases/key-action/COVID-
19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf?u
a=1. Last accessed on 23Apr 2020. 
10. Risk assessment and management of exposure of health care workers in the 
context of COVID-19. WHO Interim Guidance, 19 Mar 2020. 
https://apps.who.int/iris/bitstream/handle/10665/331496/WHO-2019-nCov-
HCW_risk_assessment-2020.2-eng.pdf. Last accessed on 14 Apr 2020. 
11. International Society for Pharmacoepidemiology (ISPE). Guidelines for good 
pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 
2008;17(2):200-208. 
12. Binkin N, Michieletto F, Salmaso S, et al. Protecting our health care workers 
while protecting our communities during the COVID-19 pandemic: a 
comparison of approaches and early outcomes in two Italian regions, Italy, 
2020. https://www.medrxiv.org/content/10.1101/2020.04.10.20060707v1. 
13. Tailoring malaria interventions in the COVID_19 response. 2020. Geneva: 
World Health Organization. License CC BY-NC-SA 3.0 IGO. 
14. International Coalition of Medicines Regulatory Authorities. ICRMA Meeting 6 
April 2020: COVID-19 Real World Evidence and Observational studies. 

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Appendix 1: WHO Ordinal Scale for Clinical Improvement 9
Note: This scale has been used as a basis and adapted for the abbreviated version being employed in this 
study. 

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Appendix 2: Detailed SoA 

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Variable domain 
At 
Enrollment 
Weekly follow-up 
(until Week 12) 
HCW 
HCW 
Contact 
Inclusion/eligibility criteria 
Screening questions 
X
-
-
Index date (date of first COVID-19 exposure)
X
X
-
Electronic/Paper (if applicable) consent 
X
-
-
Demographics 
Contact information 
X
-
-
Secondary contact
X
-
-
Facility 
X
-
-
Date of birth (Age)
X
-
-
Gender
X
-
-
Weight
X
-
-
Height
X
-
-
Race
X
-
-
Blood type
X
-
-
Smoking status (current/past/never smoked)
X
-
-
BCG vaccination history (date, time period)
X
-
-
WHO Ordinal Scale for Clinical Improvement of COVID-19 
(adapted, abbreviated version) 
SARS-CoV-2 (uninfected/ infected)
X
X
X
Ambulatory status (limitation/no limitation of activities)
X
X
X
Hospitalized with no ICU or mechanical ventilation (mild)
X
X
X
Hospitalized with ICU or mechanical ventilation (severe)
X
X
X
Death
-
-
X
Prophylactic treatments (treatment exposure) 
Treatment name
X
X
-
Date started
X
X
-
Date stopped
X
X
-
Dose (intake)
X
X
-
Duration of treatment
X
X
-
Dose frequency and dosing interval
X
X
-
Status (stopped/ongoing)
X
X
-
  Reason for stopping (not available/side effects/ expense/other) 
X 
X 
- 
Number of missed doses (yes/no)
X
X
-
If yes, reason? (not available/side effects/expense/other)
X
X
-
History of exposure to COVID-19 patients
  Self-reported ongoing and recurrent exposure (yes/no) 
X 
X 
- 
WHO exposure definition (3 questions) (yes/no)
X
X
-
Direct care to COVID-19 patient (yes/no)
X
X
-
Face-to-fact contact (yes/no)
X
X
-
Present during aerosol-generating procedures (yes/no)
X
X
-
Days worked past week
-
X
-
Number of COVID-19 cases exposed to in the past week
-
X
-
Personal Protective Equipment  
Mask (N95 respirator mask or other) (if yes, always/not always)
X
X
-
Eye protection/goggles/face shield (if yes, always/not always)
X
X
-
Gown (if yes, always/not always)
X
X
-
Gloves (if yes, always/not always)
X
X
-
If “not always” or “no” for mask:

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  Number of COVID-19 cases exposed to in the absence of a 
mask in the prior week
- 
X 
- 
Longest COVID-19 exposure in the absence of a mask
-
X
-
COVID-19 symptoms 
Develop symptoms (yes/no), if yes – date the symptoms begin:
X
X
-
Fever (temperature over 38℃)
X
X
-
Subjective fever (felt feverish)
X
X
-
Chills
X
X
-
Myalgia (muscles hurt or ache)
X
X
-
Rhinorrhea (runny or drippy nose)
X
X
-
Pharyngitis (sore throat)
X
X
-
Cough (new onset or worsening of chronic cough)
X
X
-
Dyspnea (hard to breathe or difficulty breathing)
X
X
-
Pneumonia
X
X
-
Nausea or vomiting
X
X
-
Headache or migraine
X
X
-
Abdominal pain (pain in tummy)
X
X
-
Asthenia (weakness or loss of strength)
X
X
-
Arthralgia (joint pain)
X
X
-
Anosmia (loss of smell)
X
X
-
Ageusia (loss of taste)
X
X
-
Blue coloring in toes
X
X
-
Diarrhea (two or more looser-than-normal stools in 24 hours)
X
X
-
SARS-CoV-2 testing  
Tested? (yes/no)
X
X
-
Type of test
X
X
-
PCR (positive/negative)
X
X
-
Antigen test (positive/negative)
X
X
-
  Serology (IgG and/ or IgM, positive/negative or titer) 
X 
X 
- 
Date of test 
X
X
-
Serology testing
X
X
-
Household history (COVID-19) 
Number of household contacts
X
X
-
  Additional household member(s) exposed to COVID-19 
(yes/no) If yes, how many?
X 
X 
- 
  Additional household member(s) with symptoms consistent 
with COVID-19 (yes/no) If yes, how many?
X 
X 
- 
  Additional household member(s) diagnosed with COVID-19 
(yes/no) If yes, how many?
X 
X 
- 
Underlying conditions and key morbidities 
Chronic lung disease 
X
-
-
Diabetes mellitus 
X
-
-
Cardiovascular (heart) disease 
X
-
-
Chronic renal (kidney) disease 
X
-
-
Chronic liver disease 
X
-
-
  Immunocompromised condition (HIV/AIDS, organ transplant, 
other)
X 
- 
- 
Tuberculosis 
X
-
-
Neurologic/neurodevelopmental 
X
-
-
Hypertension (high blood pressure)
X
-
-
History of stroke
X
-
-
Other chronic diseases 
X
-
-
If female, currently pregnant 
X
-
-
If female, currently breastfeeding/lactating
X
-
-
Job characteristics 
Type of healthcare work
X
-
-

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Primary work location (ED, ICU, Medical floor)
X
X
-
Number of hours with patients
X
X
-
Concomitant medications (other than for COVID-19) 
Antibiotics (yes/no)
X
X
-
Antimalarials (yes/no)
X
X
-
Antiparasitics (yes/no)
X
X
-
Antiretrovirals for HIV (yes/no)
X
X
-
Antivirals (yes/no)
X
X
-
  Medication for high blood pressure and cardiovascular disease 
(yes/no)
X 
X 
- 
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (yes/no)
X
X
-
Botanicals (yes/no)
X
X
-
Immunocompromising drugs (yes/no)
X
X
-
COVID-19 vaccine (to be selected as applicable)
Convidicea (Ad5-nCoV)
X
X
CoronaVac (Sinovac)
X
X
Covaxin (BBV152)
X
X
EpiVacCorona (Vector Institute)
X
X
Janssen Pharmaceuticals (Johnson & Johnson) (Ad26.COV2.S)
X
X
Moderna COVID-19 Vaccine
X
X
Novavax (NVX-CoV2373)
X
X
Oxford-AstraZeneca COVID-19 Vaccine
X
X
Pfizer-BioNTech COVID-19 Vaccine
X
X
Sinopharm BBIBP-CorV
X
X
Sputnik V COVID-19 Vaccine
X
X
Other (please specify)
X
X

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Appendix 3: List of Prophylactic Treatments 
Select ALL that apply 
1. Chloroquine - specify dose and interval 
2. Hydroxychloroquine - specify dose and interval 
3. Azithromycin - specify dose and interval 
4. Lopinavir/ritonavir - specify dose and interval 
5. Ivermectin - specify dose and interval 
6. Other 1 – specify therapeutic, dose and interval 
7. Other 2 – specify therapeutic, dose and interval 
8. Other 3 – specify therapeutic, dose and interval 

Signature Page for VV-TMF-757477 v0.1
Signature Page for VV-TMF-757477 v0.1
Reason for signing: Approved
Name: Roman Casciano
Role: Sponsor
Date of signature: 17-Jun-2021 16:41:02 GMT+0000