Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings
Phase: NA
Conditions: Healthy
Sponsor: Alachua Government Services, Inc.

Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 1 of 75 
 
CLINICAL STUDY PROTOCOL 
Title: 
Phase 1 Study Evaluating Technologies for Point-of-Care 
Blood Collections in Support of Decentralized Outpatient 
Assessments in Pandemic and Clinical Trial Settings 
Short title:  
Evaluating Technologies for Point-of-Care Blood 
Collections by Patients 
Protocol number:  
5309/0024 
Study phase:  
Phase 1 
Device:  
Tasso+™ Device (third generation) 
Sponsor/Principal 
Investigator:  
Resilience Government Services, Inc. 
Jordan Bauers, PharmD 
13200 NW Nano Court, Alachua, FL 32615 
email: Jordan.Mitchell@resilience.com 
Fax: +1 888 551 1691 
Funding mechanism:  
Department of Defense (DoD) 
Joint Program Executive Office (JPEO) 
Agreement #W911QY-20-9-0007 
Contract research 
organization:  
ICON plc 
Corporate Headquarters 
South County Business Park 
Leopardstown, Dublin 18  
Ireland 
Phone (IRL): +353 1 291 2000 
Phone (US): +1 215 616 3000  
Fax: +353 1 247 6260 
Protocol version and 
date:  
Version 3.0, 17 Jan 2025 
The study will be performed in compliance with this protocol (clinical investigation 
plan), in accordance with the Note for Guidance on International Council for 
Harmonisation guidelines on Good Clinical Practice (ICH GCP) Harmonised Tripartite 
Guideline E6 (R1)/Integrated Addendum E6 (R2); US FDA CFR (Title 21 Parts 50, 56, 
312). 
This document is a confidential communication of Resilience Government Services, Inc 
(Jordan Bauers, PharmD). Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein shall be published or 
disclosed without prior written approval by the Sponsor, except that this document will 
be disclosed to the appropriate Institutional Review Board(s)/Independent Ethics 
Committee(s) under the condition that they keep it confidential. 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD 
Protocol Number: 5309/0024
Protocol Version and Date: Version 3.0 – 17 Jan 2025
Page 2 of 75
PROTOCOL SIGNATURE PAGE – SPONSOR
This protocol (5309/0024, Version 3.0, 17 Jan 2025) has been reviewed and approved by 
the representative(s) listed below. Any modification of the protocol must be agreed upon 
by the Sponsor and the Investigator and must be documented in writing.
Jordan Bauers, PharmD
Resilience Government Services, Inc. 
13200 NW Nano Court, Alachua, FL 32615
email: Jordan.Mitchell@resilience.com
Fax: +1 888 551 1691:
Print Name
Title
Signature
Date
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD 
Protocol Number: 5309/0024
Protocol Version and Date: Version 3.0 – 17 Jan 2025
Page 3 of 75
PROTOCOL SIGNATURE PAGE – CONTRACT RESEARCH 
ORGANIZATION
This protocol has been reviewed and approved by the representative(s) listed below. Any 
modification of the protocol must be agreed upon by the Sponsor and the Investigator and 
must be documented in writing.
ICON representative(s):
Print Name
Title
Signature
Date
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 4 of 75 
 
PROTOCOL SIGNATURE PAGE – INVESTIGATOR 
I have read this protocol, which has been agreed to by Resilience Government Services, 
Inc. (Jordan Bauers, PharmD) and given approval/favorable opinion by the IRB/IEC, and 
I agree that it contains all necessary details to conduct this study as described. I will 
provide copies of the protocol and any amendments to all study personnel under my 
supervision and provide access to all information provided by Resilience Government 
Services, Inc. (Jordan Bauers, PharmD) or his specified designees. I will discuss the 
material with the study personnel to ensure that they are fully informed about the study. 
I understand that information contained in or pertaining to this protocol is confidential 
and should not be disclosed, other than to those directly involved in the execution or the 
ethical review of the study, without written authorization from Resilience Government 
Services, Inc. (Jordan Bauers, PharmD). It is, however, permissible to provide 
information to a participant in order to obtain consent. 
I agree to conduct this study according to this protocol and to comply with its 
requirements, subject to ethical and safety considerations and guidelines, and to conduct 
the study in accordance with the Declaration of Helsinki, ICH GCP, and applicable 
regional regulatory requirements. 
I agree to comply with the procedures described for data recording and reporting and to 
permit monitoring and auditing by Resilience Government Services, Inc. (Jordan Bauers, 
PharmD), and inspection by the appropriate regulatory authorities. 
I agree to make my participants’ study records available to Resilience Government 
Services, Inc. (Jordan Bauers, PharmD), his personnel, his representatives, and relevant 
regulatory authorities in order to verify data that I have entered into the electronic case 
report forms (eCRFs). I will retain the study-related essential documents until Resilience 
Government Services, Inc. (Jordan Bauers, PharmD) indicates that they are no longer 
needed. I am aware of my responsibilities as an Investigator as provided by Resilience 
Government Services, Inc. (Jordan Bauers, PharmD). 
I understand that Resilience Government Services, Inc. (Jordan Bauers, PharmD) may 
decide to suspend or prematurely terminate the study at any time for whatever reason; 
such a decision will be communicated to me in writing. Conversely, should I decide to 
withdraw from execution of the study, I will communicate my intention immediately in 
writing to Resilience Government Services, Inc. (Jordan Bauers, PharmD). 
Investigator (Name, Title, Institution): 
 
 
 
 
 
Signature 
 
Date 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 5 of 75 
 
SERIOUS ADVERSE EVENT CONTACT INFORMATION 
In the event of a serious adverse event (SAE), the Investigator will send a safety report 
form immediately (no later than 24 hours) after becoming aware of the SAE to: 
ICON Pharmacovigilance and Safety Services (PVSS) Americas 
Phone: 
+1 888 426 8801 
Fax: 
+1 215 616 3096 
Email: 
icon-mads@iconplc.com 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 6 of 75 
 
PROTOCOL SUMMARY 
Protocol number: 5309/0024 
Protocol title: Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support 
of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings 
Short title: Evaluating Technologies for Point-of-Care Blood Collections by Patients 
Sponsor/Principal Investigator (PI): Resilience Government Services, Inc. (Jordan Bauers, PharmD) 
13200 NW Nano Court, Alachua, FL 32615; email: Jordan.Mitchell@resilience.com; Fax: +1 888 551 
1691 
Funding: Department of Defense, Joint Program Executive Office, Agreement #W911QY-20-9-0007 
Study phase: Phase 1 
Clinical sites: It is planned to recruit up to 5 sites in the US 
Objectives and endpoints: 
Primary objective 
Primary endpoints 
To assess the Tasso+™ 
performance (sample integrity, 
testing accuracy, and reliability) 
x 
Percentage of overall Tasso+™/serum separator tube 
(SST) samples collected that are with adequate volume and 
without moderate or gross hemolysis on Day 1 for each 
cohort and on each of Days 29 and 57 for Cohorts A and B 
combined 
x 
Percentage of overall Tasso+™/ 
ethylenediaminetetraacetic acid (EDTA) samples collected 
that are with adequate volume, without moderate or gross 
hemolysis, and without clotting on Day 1 for each cohort 
and on each of Days 29 and 57 for Cohorts A and B 
combined 
x 
Correlation of SARS-CoV-2 serology between 
venipuncture and Tasso+™/SST or Tasso+™/EDTA 
samples on Day 1 for each cohort 
x 
Correlation of each chemistry analyte between 
venipuncture and Tasso+™/SST samples on Day 1 for 
each cohort 
x 
Percentage of Tasso+™ device failures from Day 1 to 
Day 57 defined as (i) failure in activation of the lancet; (ii) 
lack of any blood collection within 5 minutes; (iii) 
incorrect attachment of the capillary collection tube to the 
device; (iv) damage to the device or the capillary collection 
tube upon handling; (v) lack of maintained seal between 
the device and the skin surface of the participant; or (vi) 
incomplete trigger of the button (not fully pressing the 
button once the Tasso+™ device is sealed to the skin 
surface) 
 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 7 of 75 
 
Secondary objectives 
Secondary endpoints 
To evaluate Tasso+™ user 
experience (safety, tolerability, 
and usability) 
x 
Percentage of eligible participants who experience solicited 
local adverse events (AEs) including pain, tenderness, 
redness, swelling, or bruising within 7 days of Tasso+™ 
administration 
x 
Percentage of eligible participants who experience 
unsolicited AEs within 28 days of Tasso+™ administration  
x 
Percentage of eligible participants who experience a 
related Grade 3 AE, a related Grade 4 AE, a related AE 
leading to study discontinuation, or a related SAE within 
28 days of Tasso+™ administration 
x 
Percentage of eligible participants who complete last 
Tasso+™ administration (Day 57) 
x 
Ease of use as assessed by the participant completing the 
Tasso questionnaire immediately following administration 
(on Days 1, 29, and 57) and on Day 85 
To perform surveillance for 
SARS‑CoV‑2 infection 
x 
Percentage of eligible participants with a positive 
nasopharyngeal swab for SARS-CoV-2 polymerase chain 
reaction (PCR) on Day 1 
x 
Percentage of eligible participants seroconverting to 
SARS-CoV-2 between Days 1 and 57  
Exploratory objective 
Exploratory endpoint 
To evaluate the impact of prior 
training on subsequent Tasso+™ 
administrations 
x 
Descriptive analyses of proctor-supported and proctor-
unsupported Tasso+™ administrations on Day 57 using 
each of the following endpoints: 
o 
Sample integrity 
o 
Reliability 
o 
Safety 
o 
Usability 
Study design: 
This is a Phase 1, multicenter, observational, study that will evaluate the Tasso+™ device in 
approximately 200 male or female adult participants in an outpatient setting who are healthy or in 
well‑compensated health at up to 5 US sites. They will be randomized in a 2:1 ratio between Cohorts A 
and B. Tasso+™ blood samples of participants randomized to Cohort A will be shipped to the Central 
Laboratory where they will be centrifuged and aliquoted. However, Tasso+™ blood samples of 
participants randomized to Cohort B will be centrifuged and aliquoted at the Site prior to shipping to the 
Central Laboratory, following the same approach used for venipuncture blood samples.  
Baseline information regarding COVID-19 experience will be elicited to include prior vaccination(s) and 
prior or new illness consistent with COVID-19. The SARS‑CoV‑2 infection surveillance during the 
study will comprise SARS-CoV-2 PCR screen at study entry, regular symptom checks at each visit and 
assessment for SARS-CoV-2 seroconversion between Day 1 and Day 57. 
Training on the Tasso+™ will consist of a detailed Instruction for Use (IFU) and online video training. 
In addition, when administering the Tasso+™ remotely, participants will receive proctor-support on 
Day 29 (and if requested, on Day 57) during working hours, the intent being to guide the participant 
through the process and to help troubleshoot should any difficulties be encountered. 
Collection: Participants, once trained on the Tasso+™ device, will perform two Tasso+™ self-
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 8 of 75 
 
administrations (preferably collecting a SST tube from left upper arm and an EDTA tube from right 
upper arm) on each of Days 1, 29 and 57. Participants will complete a Tasso questionnaire (available in 
eDiary) immediately following each Tasso+™ administration (Days 1, 29 and 57) and on Day 85 to 
document the user experience. Additionally, the participants will complete a Symptom questionnaire 
(available in eDiary) for a 28‑day period following each Tasso+™ administration to report symptoms. 
Safety data collection will be solicited from each participant for the first 7 days after each Tasso+™ 
administration and unsolicited AEs will be captured for a 28-day period after each Tasso+™ 
administration. 
On Day 1, in the Clinic, the blood collected by the participant (site-supervised) using the Tasso+™ and 
the blood collected by a qualified healthcare professional (HCP) using venipuncture will be compared 
with respect to testing accuracy for SARS-CoV-2 serology and for selected chemistry analytes. For 
Cohort A participants, the venipuncture collection tube(s) will be centrifuged and aliquoted prior to 
shipping, while the Tasso+™ capillary collection tube will be centrifuged and aliquoted after shipping to 
the Central Laboratory. For Cohort B participants, both Tasso+™ and venipuncture tubes will be 
centrifuged and aliquoted prior to shipping to the Central Laboratory. Tasso+™ and venipuncture 
collections will be both packed and shipped by the HCP during this visit. 
On Day 29, blood will be collected remotely by the participant (proctor-supported) using the Tasso+™ 
device in a decentralized setting, according to provided training and instructions. The Tasso+™ tubes 
will be both packed and shipped by the participant for this visit. 
On Day 57, blood will be collected remotely by the participant (proctor-supported as requested) using 
the Tasso+™ device in a decentralized setting, according to provided training and instructions. While 
assistance will be available to the participant during this visit, it is of interest to know whether the prior 
trainings on Tasso+™ administration prove adequate for this subsequent administration. The Tasso+™ 
tubes will be both packed and shipped by the participant for this visit. 
Packaging, and shipment: Participants, once trained, will self-administer the Tasso+™ in the Clinic 
(site‑supervised) on Day 1, while the Site will centrifuge and aliquot (Cohort B samples only), and 
package and ship the samples to the Central Laboratory (see Figure 1). The participant will self-
administer the Tasso+™ subsequently remotely at home, ie, at home or a suitable remote location 
(proctor-supported on Day 29 and, as requested on Day 57). Participants will package and ship the 
samples to the Central Laboratory. 
Sample processing and testing: After samples have been received by the Central Laboratory, both SST 
and EDTA capillary collection tubes will be centrifuged and aliquoted (Cohort A samples only) for 
testing by the Central Laboratory. 
The parameters to be used to assess sample integrity (both SST and EDTA samples) will be 
measured/assessed by the Central Laboratory and will comprise blood volume, hemolysis, and for EDTA 
alone, the determination of presence of clotting. 
The parameters to be used to assess the testing accuracy using Tasso+™ capillary-drawn samples when 
compared to those collected by venipuncture will include SARS-CoV-2 serology (SST and EDTA 
samples) and selected chemistry analytes (SST samples only). 
The final Visit (Day 85) will be conducted to complete the final Symptom questionnaire and the 
Tasso+™ questionnaire. 
Study duration: 
Each participant’s study involvement will last for approximately 85±3 days. 
The start of the study will be the date the first participant provides informed consent, and the end of the 
study will be the date the last participant receives the final assessment.  
Planned number of participants: It is planned to enroll approximately 200 participants. 
It is planned to randomize approximately 133 participants into Cohort A and approximately 
67 participants into Cohort B. 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 9 of 75 
 
Target population: 
Participants aged 18 years or older who are considered healthy or in well-compensated health as 
determined by the Investigator based on medical history, concomitant medications, and physical 
examination (including vital signs) would satisfy the inclusion criteria for study eligibility. Regardless of 
the pregnancy test result (positive or negative), the participant will remain eligible for study 
participation. Thus, the participants who are deemed pregnant by urine pregnancy test at Screening 
remain eligible.  
A participant who meets any of the following exclusion criteria will not be eligible for participating in 
the study: 
1. 
Medical history, or physical examination (including vital signs) findings, that suggest to the 
Investigator that the participant has undiagnosed or untreated medical condition(s) that could 
confound the AE evaluation and thereby undermine the study objectives. 
2. 
Any known medical history of infection with HIV (CD4<200 and/or detectable viral load within the 
prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive hepatitis C virus antibody). 
3. 
Chronic illness for which a participant’s immune system is suspected by the Investigator to be 
impaired or altered, such as cancer, autoimmune conditions, and diabetes. 
4. 
Participation in another investigational study within 30 days of time of consent or plans to do so 
during the course of this study. 
5. 
Large tattoos or skin eruptions overlying either of the deltoid muscles that could confound the 
monitoring for local reactogenicity following Tasso+™ administrations. 
6. 
Use of systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 
months; or planned use of medications or nutritional supplements known to or which potentially 
could affect organ function within 30 days prior to screening until end of study. 
7. 
Acute illness within 14 days prior to device use unless it is determined by the Investigator that the 
illness is mild in severity and unlikely to progress. 
8. 
Of limited legal capacity. 
9. 
Any condition (including suspected alcohol- or drug-related addiction) that precludes adequate 
understanding, cooperation, and/or compliance with study procedures or any condition that could 
pose a risk to the participant’s safety per Investigator judgment. 
Device: 
Name: Tasso+™ Device (third generation) 
Description: Tasso+™ device lancet is an FDA 510(k)-cleared Class II medical device in the US. The 
Tasso+™ kits are designed to collect up to 600 μL of blood within 5 minutes. 
Statistical methods: 
Descriptive statistics will be used to summarize primary endpoints, ie, device performance (sample 
integrity, testing accuracy and reliability), as well as secondary endpoints, ie, user experience (safety, 
tolerability, and usability) and seroconversion. 
The analysis set for the primary endpoints will be the full analysis set (FAS). Where appropriate the 
analyses will be repeated for the per protocol analysis set (PPS). 
The details of all analyses will be specified in a separate statistical analysis plan (SAP).  
Safety assessments will be analyzed using the safety analysis set (SAS). 
Protocol version and date: Version 3.0, 17 Jan 2025 
 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD 
Protocol Number: 5309/0024
Protocol Version and Date: Version 3.0 – 17 Jan 2025
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STUDY SCHEMATIC
Figure 1
Study Schematic
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
Protocol Version and Date: Version 3.0 – 17 Jan 2025 
Page 11 of 75 
 
 
Footnotes: 
a eDiary will be completed during each follow-up period to collect safety data (Symptom questionnaire) and user experience (Tasso questionnaire). 
b Day 1 collection to be site-supervised; venipuncture samples (SST and EDTA tubes) and Cohort B Tasso+™ samples (SST and EDTA capillary collection tubes) to be centrifuged and aliquoted by 
the Site before shipping; venipuncture samples (SST and EDTA tubes) and Tasso+™ samples (SST and EDTA capillary collection tubes) to be shipped to Central Laboratory by the Site; Cohort A 
Tasso+™ samples (SST and EDTA capillary collection tubes) to be centrifuged and aliquoted by the Central Laboratory upon receipt. 
c Day 29 collection to be remotely proctor-supported (during working hours); Tasso+™ samples (SST and EDTA capillary collection tubes) to be packaged and shipped to Central Laboratory by the 
participant. 
d Day 57 collection to be remotely proctor-supported (during working hours), as requested; Tasso+™ samples (SST and EDTA capillary collection tubes) to be packaged and shipped to Central 
Laboratory by the participant. 
e eDiary (Tasso questionnaire) will be completed immediately following each Tasso+™ administration and on Day 85 to document the user experience. 
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Protocol Number: 5309/0024 
 
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SCHEDULE OF ASSESSMENTS 
Table 1 
Schedule of Assessments 
Assessments 
Visitsa 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Study Day (±visit window) 
1 
29±3 
57±3 
85±3 
In-clinic 
X 
 
 
 
Decentralized (eg, home)b 
 
X 
X 
X 
Proctor sessionc 
 
Xc 
(X)c 
 
Training 
Xc 
Xc 
(X)c 
 
Informed consent (eConsent) 
X 
 
 
 
Demographics 
X 
 
 
 
Medical historyd 
X 
 
 
 
Concomitant medication 
X 
X 
X 
X 
Vital signse 
X 
 
 
 
Physical examinationf 
X 
 
 
 
Pregnancy urine test (females only) 
X 
 
 
 
Eligibility check 
X 
 
 
 
Randomization (IVRS) 
X 
 
 
 
COVID-19 symptom screeng 
X 
X 
X 
X 
Nasopharyngeal swab for SARS-CoV-2 PCRh 
X 
 
 
 
Tasso+™ collection 
SST capillary collection tube (left upper arm 
preferred) 
EDTA capillary collection tube (right upper arm 
preferred) 
 
Xil  
Xil 
 
Xjl  
Xjl 
 
Xkl  
Xkl 
 
Venous blood collection 
SST tube  
EDTA tube 
 
Xim  
Xim 
 
 
 
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Sponsor Name: Resilience Government Services, Inc., Jordan Bauers, PharmD  
 
Protocol Number: 5309/0024 
 
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Assessments 
Visitsa 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Study Day (±visit window) 
1 
29±3 
57±3 
85±3 
eDiary 
Tasso questionnaire (user experience) 
Symptom questionnaire (AEs/SAEs)n 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
AE=adverse event; EDTA=ethylenediaminetetraacetic acid; IFU=instruction for use; IVRS=interactive voice response system; HCP=healthcare professional; PCR=polymerase chain reaction; 
SAE=serious adverse event; SST=serum-separator tube 
Footnotes: 
a If a participant withdraws from the study early, the assessments planned for the last follow-up/end of study Visit should be completed at the time of withdrawal. 
b Defined as any remote location of convenience for the participant where the administration can be done with appropriate technique in a clean environment where samples can be packaged for 
shipment. 
c When administering the Tasso+™ remotely, participants will receive proctor-support on Day 29 (and as requested, on Day 57), the intent being to guide the participant through the process and to 
help troubleshoot should any difficulties be encountered. Proctor sessions will be prescheduled by the Site to take place during working hours. Training will be performed on Day 1 (by Site) and 
Day 29 (by Proctor). Training on Day 57 should be performed only if requested by the participant. Training may include detailed IFU and online video training (see Section 7.4 and IFU provided 
separately). While assistance will be available to the participant during Day 57 Visit, it is of interest to know whether the prior trainings on Tasso+™ administration prove adequate for this 
subsequent administration. 
d Includes COVID-19 illness/vaccine history details (if available). 
e Vital signs include heart rate, systolic and diastolic blood pressure, respiratory rate, SpO2 by pulse oximetry, and body temperature (taken by ear/tympanic/temporal, oral, or forehead method). The 
assessment of heart rate and blood pressure will be conducted in the supine position after a minimum rest period of 5 minutes. 
f Physical examination includes general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological, and other 
body systems, if applicable, for describing the status of the participant’s health. 
g The development of any COVID-19 symptoms should prompt the participant to contact the Investigator via provided Site’s phone number. 
h Nasopharyngeal swab for SARS-CoV-2 PCR will be performed and resulted by the Site. 
i Day 1 collections: venipuncture samples by HCP (SST and EDTA tubes) and Tasso+™ samples by participant (SST and EDTA capillary collection tubes; Cohort B only) to be centrifuged and 
aliquoted by the Site before shipping; venipuncture samples by HCP (SST and EDTA tubes) and Tasso+™ samples by participant (SST and EDTA capillary collection tubes) and to be shipped to 
Central Laboratory by the Site. 
j Day 29 collection remotely proctor-supported (during working hours); Tasso+™ samples (SST and EDTA capillary collection tubes) to be packaged and shipped to Central Laboratory by the 
participant.  
k Day 57 collection remotely proctor-supported, as requested (during working hours); Tasso+™ samples (SST and EDTA capillary collection tubes) to be packaged and shipped to Central Laboratory 
by the participant.  
L Tasso+™ samples will be tested by Central Laboratory. Assessments include (by order of priority): 
- Volume measurement (SST and EDTA capillary collection tubes), hemolysis (SST and EDTA capillary collection tubes), and evidence of clotting (EDTA capillary collection tube only). 
- Chemistry analytes (SST capillary collection tube): sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C-reactive protein. 
- Serology (SST and EDTA capillary collection tubes); any participant who is positive for IgG Nucleocapsid assay for either capillary matrix (SST or EDTA) will be considered positive. 
m Venipuncture samples will be tested by Central Laboratory. Assessments include: 
- Chemistry analytes (SST tube): sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C-reactive protein. 
- Serology (SST and EDTA tubes); any participant who is positive for IgG Nucleocapsid assay for either matrix (SST or EDTA) will be considered positive. 
n Including training for eDiary on Visit 1. Participant can report any AE in the eDiary (Symptom questionnaire). Safety data collection will be solicited from participant for the first 7 days after 
Tasso+™ device administration, and unsolicited AEs will be captured for the full 28-day period after each administration. 
 
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Protocol Number: 5309/0024 
 
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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ...................................................................................1 
PROTOCOL SIGNATURE PAGE – SPONSOR ...........................................................2 
PROTOCOL SIGNATURE PAGE – CONTRACT RESEARCH 
ORGANIZATION ......................................................................................................3 
PROTOCOL SIGNATURE PAGE – INVESTIGATOR ...............................................4 
SERIOUS ADVERSE EVENT CONTACT INFORMATION .....................................5 
PROTOCOL SUMMARY ................................................................................................6 
STUDY SCHEMATIC ....................................................................................................10 
SCHEDULE OF ASSESSMENTS .................................................................................12 
TABLE OF CONTENTS ................................................................................................14 
LIST OF TABLES ...........................................................................................................17 
LIST OF FIGURES .........................................................................................................17 
LIST OF ABBREVIATIONS .........................................................................................18 
1 
INTRODUCTION AND RATIONALE .................................................................19 
1.1 
Introduction ..........................................................................................................19 
1.1.1 
Background ....................................................................................................19 
1.1.2 
Investigational Medical Device .....................................................................20 
1.1.3 
Previous Clinical Use .....................................................................................21 
1.2 
Study Rationale ....................................................................................................23 
1.3 
Benefit/Risk Assessment ......................................................................................25 
2 
STUDY OBJECTIVES ............................................................................................27 
2.1 
Primary Objective ................................................................................................27 
2.2 
Secondary Objectives...........................................................................................27 
2.3 
Exploratory Objective .........................................................................................27 
3 
STUDY ENDPOINTS ..............................................................................................28 
3.1 
Primary Endpoints...............................................................................................28 
3.2 
Secondary Endpoints ...........................................................................................28 
3.3 
Exploratory Endpoint ..........................................................................................29 
4 
STUDY PLAN ...........................................................................................................30 
4.1 
Overall Study Design and Plan ...........................................................................30 
4.2 
Steps to the Process ..............................................................................................31 
4.2.1 
Training ..........................................................................................................31 
4.2.2 
Blood Collection .............................................................................................31 
4.2.3 
Blood Volume and Clotting Analyses ...........................................................32 
4.2.4 
Centrifugation ................................................................................................32 
4.2.5 
Shipping ..........................................................................................................32 
4.2.6 
Hemolysis Analysis.........................................................................................32 
4.2.7 
Testing .............................................................................................................32 
4.3 
Management of Device Failures .........................................................................33 
4.4 
Management of COVID-19 Positive Participant ..............................................33 
4.5 
End of Study .........................................................................................................34 
4.5.1 
Completion......................................................................................................34 
4.5.2 
Discontinuation ..............................................................................................34 
4.5.3 
Withdrawal .....................................................................................................34 
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4.5.4 
Study Halting Criteria ...................................................................................35 
5 
STUDY POPULATION ...........................................................................................36 
5.1 
Inclusion Criteria .................................................................................................36 
5.2 
Exclusion Criteria ................................................................................................36 
5.3 
Screen Failures .....................................................................................................37 
5.4 
Premature Withdrawal/Discontinuation from the Study ................................37 
6 
DESCRIPTION OF STUDY PROCEDURES AND ASSESSMENTS ...............39 
6.1 
Recruitment/Screening Visit ...............................................................................39 
6.1.1 
Recruitment ....................................................................................................39 
6.1.2 
Informed Consent ..........................................................................................39 
6.1.3 
Demographics .................................................................................................39 
6.1.4 
Medical History ..............................................................................................39 
6.1.5 
Vital Signs .......................................................................................................40 
6.1.6 
Physical Examination ....................................................................................40 
6.1.7 
Pregnancy Test ...............................................................................................40 
6.1.8 
Identification ..................................................................................................40 
6.2 
Study Visits (Days 1, 29, 57, and 85) ..................................................................41 
6.3 
Endpoint Assessments .........................................................................................42 
6.3.1 
Sample Integrity .............................................................................................42 
6.3.2 
Testing Accuracy ............................................................................................43 
6.3.3 
Reliability ........................................................................................................44 
6.3.4 
Safety ...............................................................................................................44 
6.3.5 
Tolerability .....................................................................................................44 
6.3.6 
Usability ..........................................................................................................44 
6.3.7 
SARS‑CoV‑2 Infection Surveillance ............................................................45 
6.4 
Safety Assessments ...............................................................................................45 
6.4.1 
Adverse Events ...............................................................................................45 
6.4.2 
Pregnancy .......................................................................................................45 
6.4.2.1 
Pregnant Trial Participant (Incidental Pregnancy)..............................45 
6.4.2.2 
Pregnant Partner of a Trial Participant ................................................45 
6.4.3 
Breastfeeding ..................................................................................................46 
6.5 
Sample Collection Storage ..................................................................................46 
7 
INTERVENTIONS ...................................................................................................47 
7.1 
Investigational Medical Device ...........................................................................47 
7.1.1 
Description of Investigational Medical Device ............................................47 
7.1.2 
Preparation, Handling, and Storage ............................................................47 
7.1.3 
Sterilization .....................................................................................................47 
7.1.4 
Packaging, Labelling, and Shipment ............................................................48 
7.2 
Blinding .................................................................................................................48 
7.3 
Method of Assigning Process ..............................................................................48 
7.4 
Instruction for Use ...............................................................................................48 
7.5 
Precautions and/or Lifestyle Considerations.....................................................49 
7.6 
Prior Medication and Procedures ......................................................................49 
7.7 
Concomitant Medication and Procedures .........................................................49 
7.8 
Accountability ......................................................................................................50 
8 
ADVERSE EVENTS ................................................................................................51 
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8.1 
Definitions .............................................................................................................51 
8.1.1 
Adverse Events ...............................................................................................51 
8.1.2 
Adverse Device Effects ..................................................................................51 
8.1.3 
Serious Adverse Events .................................................................................51 
8.1.3.1 
Life-Threatening AE ................................................................................51 
8.1.3.2 
AE Requiring Hospitalization .................................................................52 
8.1.3.3 
Disability/Incapacity ................................................................................52 
8.1.4 
Serious Adverse Device Effects .....................................................................52 
8.1.5 
Unanticipated Serious Adverse Device Effects ............................................52 
8.1.6 
Device Deficiencies .........................................................................................52 
8.1.7 
Malfunctions ...................................................................................................53 
8.1.8 
User Errors .....................................................................................................53 
8.2 
Assessment of Adverse Events ............................................................................53 
8.2.1 
Severity............................................................................................................53 
8.2.2 
Causality .........................................................................................................53 
8.2.3 
Expectedness ...................................................................................................53 
8.3 
Documenting and Reporting Adverse Events ...................................................53 
8.4 
Reporting of Serious Adverse Events .................................................................54 
8.5 
Adverse Event and Serious Adverse Event Follow-Up ....................................55 
8.6 
Safety Reporting Oversight .................................................................................55 
9 
STATISTICS .............................................................................................................56 
9.1 
General Procedures .............................................................................................56 
9.2 
Analysis Sets .........................................................................................................56 
9.3 
Sample Size ...........................................................................................................56 
9.4 
Statistical Methods ...............................................................................................57 
9.4.1 
Primary Endpoints.........................................................................................57 
9.4.1.1 
Sample Integrity .......................................................................................57 
9.4.1.2 
Testing Accuracy ......................................................................................57 
9.4.1.3 
Reliability ..................................................................................................57 
9.4.2 
Secondary Endpoints .....................................................................................57 
9.4.2.1 
Safety .........................................................................................................57 
9.4.2.2 
Tolerability ...............................................................................................58 
9.4.2.3 
Usability ....................................................................................................58 
9.4.2.4 
SARS‑CoV‑2 Infection Surveillance ......................................................58 
9.4.3 
Exploratory Endpoint ....................................................................................58 
9.4.4 
Analysis of Safety ...........................................................................................58 
9.4.5 
Demographic and Baseline Characteristics .................................................59 
9.4.6 
Subgroup Analyses.........................................................................................59 
9.4.7 
Handling of Missing Values ..........................................................................59 
9.5 
Interim Analysis ...................................................................................................59 
10 RECORDS MANAGEMENT..................................................................................60 
10.1 
Source Documentation.........................................................................................60 
10.2 
Case Report Form Completion and Data Management ...................................60 
10.3 
Study Files and Record Retention ......................................................................61 
11 ETHICS AND RESPONSIBILITIES .....................................................................63 
11.1 
Good Clinical Practice .........................................................................................63 
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11.2 
Institutional Review Board/Independent Ethics Committee ...........................63 
11.3 
Informed Consent ................................................................................................64 
11.4 
Recruitment Strategy...........................................................................................65 
11.5 
Data Monitoring Committee ...............................................................................65 
11.6 
Financing and Insurance .....................................................................................65 
11.6.1 
Contractual and Financial Details ................................................................65 
11.6.2 
Insurance, Indemnity, and Compensation...................................................65 
11.6.3 
Financial Disclosure .......................................................................................65 
12 AUDITING AND MONITORING ..........................................................................66 
12.1 
Monitoring ............................................................................................................66 
12.2 
Audits and Inspections ........................................................................................67 
12.3 
Risk and Quality Tolerance Limits ....................................................................67 
12.4 
Protocol Adherence and Deviations ...................................................................67 
13 AMENDMENTS .......................................................................................................69 
14 STUDY REPORT AND PUBLICATIONS ............................................................70 
15 STUDY START AND TERMINATION ................................................................71 
16 CONFIDENTIALITY ..............................................................................................72 
17 REFERENCES .........................................................................................................73 
18 APPENDICES ...........................................................................................................74 
18.1 
Appendix I – Study Administrative Structure ..................................................74 
18.2 
Appendix II – Non-Significant Risk Letter .......................................................75 
LIST OF TABLES 
Table 1 
Schedule of Assessments ..........................................................................12 
Table 2 
Tasso+™ Kit Configurations ..................................................................20 
Table 3 
Summary of LightDeck Antibody Results (Venous Whole Blood vs 
Tasso Whole Blood) (JPEO-003, Summary of Results, 2022) .............22 
Table 4 
Sample Testing Table ..............................................................................25 
Table 5 
Impact of Varying Degrees of Hemolysis (Measured by Hemolytic 
Index) on Validity of Laboratory Results ..............................................43 
LIST OF FIGURES 
Figure 1 
Study Schematic .......................................................................................10 
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LIST OF ABBREVIATIONS 
ADE 
adverse device effect 
AE 
adverse event 
CSR 
clinical study report 
DCT 
decentralized clinical trial 
DoD 
US Department of Defense 
EDC 
electronic data capture 
EDTA 
ethylenediaminetetraacetic acid 
FAS 
full analysis set 
GCP 
Good Clinical Practice 
HCP 
healthcare professional 
HJF 
Henry M. Jackson Foundation 
IB 
investigator brochure 
ICH 
International Council for Harmonisation 
IFU 
instruction for use 
IRB 
institutional review board 
IVRS 
interactive voice response system 
JPEO 
Joint Program Executive Office 
PCR 
polymerase chain reaction 
PI 
Principal Investigator 
PPS 
per protocol analysis set 
QTL 
quality tolerance limits 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOP 
standard operating procedure 
SAS 
safety analysis set 
SST 
serum-separator tube 
TEAE 
treatment-emergent adverse event 
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1 INTRODUCTION AND RATIONALE 
1.1 
Introduction 
1.1.1 
Background 
The COVID-19 pandemic has spurned the urgent need for SARS-CoV-2 testing and 
clinical trials to advance both vaccines and antivirals to rapidly achieve control of the 
pace of viral transmission and the dramatic toll on human lives worldwide. 
SARS-CoV-2 testing has oftentimes required that an ill patient (during the pandemic) or 
study participant (in the context of a clinical trial) travels to a clinic, remains in line or in 
a waiting room, and risks transmitting SARS-CoV-2 or another pathogen to clinic 
personnel and other patients. Moreover, FDA has recognized that the COVID-19 public 
health emergency may impact the conduct of clinical trials of medical products, leading 
to difficulties in meeting protocol-specified procedures, including adhering to protocol-
mandated visits and laboratory/diagnostic testing (FDA, 2021). 
Furthermore, in May 2023, the draft guidance for decentralized clinical trials (DCTs) 
issued by FDA has recognized the potential of DCTs to expand access to more diverse 
patient populations and improve trial efficiencies. Indeed, by enabling remote 
participation, DCTs may enhance convenience for trial participants, reduce the burden on 
caregivers, and facilitate research on rare diseases and diseases affecting populations with 
limited mobility or access to traditional trial sites. This may help improve study 
participant engagement, recruitment, enrollment, and retention of a meaningfully diverse 
clinical population (FDA, 2023). 
Nevertheless, the monitoring of the investigation must be ensured, based on a risk 
assessment, in order to assess protocol compliance and data quality and integrity. Indeed, 
the variability and precision of the data obtained in a DCT may differ from the data in a 
traditional site-based clinical trial. Remote assessments may differ from on-site 
assessments, particularly when trial participants are responsible for performing their own 
physiological tests (eg, home spirometry). Similarly, assessments performed by local 
healthcare professionals (HCPs) as part of routine clinical practice (eg, evaluation of 
symptoms) may also be more variable and less precise than assessments conducted by 
dedicated trial personnel (FDA, 2023). 
Enabling technologies that would allow for the collection of blood and other diagnostic 
samples at the point-of-care by the patient/participant while at home could potentially 
offer several benefits, eg, improved patient/participant convenience and comfort, early 
diagnostic sampling (and thereby potentially early diagnosis), greater participant study 
compliance (especially for pharmacokinetic and biomarker research endpoints), and relief 
of phlebotomy-related bottlenecks while reducing any potential transmission risks. 
Examples include self-collected dried blood spots used for serological screening of 
sexually transmitted infections to better reach hidden, high-risk populations (van Loo et 
al., 2017) or for routine doping controls (Fedoruk, 2020). The Tasso+™ lancet is an 
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enabling technology that is an FDA 510(k)-cleared Class II medical device that permits a 
potentially favorable blood collection experience in remote settings. 
Thus, Resilience Government Services, Inc. (Jordan Bauers, PharmD) is conducting a 
study in collaboration with the US Department of Defense (DoD) Joint Program 
Executive Office (JPEO), and the Henry M. Jackson Foundation (HJF) with the aim of 
supporting telemedicine strategies and virtual clinical trials. The objective of the study is 
to evaluate the use of the Tasso+™ blood collection device in the clinic and in a 
decentralized setting (eg, home) with respect to device performance (sample integrity, 
testing accuracy, and reliability) and user experience (safety, tolerability, and usability), 
during a SARS‑CoV‑2 infection surveillance study. 
1.1.2 
Investigational Medical Device 
Tasso, Inc has developed the Tasso+™ blood collection device that enables the 
convenient collection of blood by a lay person (eg, patient or study participant) under the 
supervision of an HCP.  
The Tasso+™ blood collection kit comprises the collection device (called the Tasso+™), 
an FDA 510(k)-cleared Class II medical device, and a capillary collection tube that 
allows for the storage of the blood in a liquid format in different matrices (Table 2).  
Table 2 
Tasso+™ Kit Configurations 
Product Kit 
Name 
Tube Type 
Color 
Blood 
Collection 
Volume 
Blood Collection 
Additive 
Tasso+™/EDTA 
K₂ EDTA 
lavender 
250-500μL 
K₂ EDTA 
Tasso+™/SST 
Serum Separator 
gold 
400-600μL 
Clot Activator with Gel 
Tasso+™/LH 
Lithium Heparin 
green 
200-400μL 
Lithium Heparin 
Tasso+™/PST 
Plasma Separator 
light green 
400-600μL 
Lithium Heparin with Gel 
EDTA=ethylenediaminetetraacetic acid; LH=lithium heparin; PST=plasma separator tube; SST=serum separator tube 
In the present study, Tasso+™ blood collection device (third generation) will be used as 
the Investigational Medical Device along with the Tasso+™/ethylenediaminetetraacetic 
acid (EDTA) kit and Tasso+™/serum separator tube (SST) kit (Table 2). 
The Tasso+™ device is designed to safely, conveniently, and reliably collect blood 
without the need of a trained phlebotomist or HCP while minimizing pain and discomfort 
to the patient or study participant. The Tasso+™ is a sterile, disposable, capillary blood 
collection device, including a lancet assembly, that is designed to allow the attachment of 
a sample tube to receive the collected capillary blood. The collection device is compatible 
with existing capillary collection tubes on the market (such as the BD microtainers®) as 
well as customized Tasso tubes. 
The Tasso+™ lancet is an FDA 510(k)-cleared Class II medical device in the US (Tasso, 
Investigator Brochure, September 2023). The Tasso+™ kits are designed to collect 
capillary blood volumes ranging from 250 to 600 μL within a 5‑minute period. 
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1.1.3 
Previous Clinical Use 
The Tasso+™ device has been tested in internal and external studies to measure the blood 
volumes collected and the user experience. Overall, a total of at least 420 participants 
have been recruited to date, either to use Tasso+™ device in studies in-clinic (blood 
collection by an HCP) or in a decentralized setting (blood self-collection by a participant 
at a remote location of convenience). These studies have aimed to measure sample 
volume, user perception, and user pain. Following the collection, the user is asked to 
complete a questionnaire assessing the frequency they would be willing to use the Tasso 
device, any associated pain, and their blood collection method preference (Tasso, 
Investigator Brochure, September 2023). 
Overall, among 420 participants, on a scale of 0-10 (zero being no pain and 10 being the 
most imaginable pain), 67% of participants reported feeling no pain, 26% of participants 
reported pain of 1, 5% reported pain of 2, and 2% of participants reported feeling pain at 
a 3 or higher with 5 being the highest reported pain. Ninety-five percent of all 
participants reported to prefer the Tasso+™ blood collection method to venipuncture and 
finger stick, and 95% of participants reported they would be willing to use the Tasso 
device at least monthly (Tasso, Investigator Brochure, September 2023). 
Recently, a multi-center, unblinded, longitudinal observational study of enabling 
technologies for COVID-19 surveillance (including the Tasso) was conducted with the 
objective to provide surveillance through enabling technologies to describe physiological 
parameters, symptoms, respiratory fluid virus levels, and host immune and inflammatory 
responses in enrolled subjects (JPEO-003, Summary of Results, 2022). 
Overall, 62 participants (52 with mild to moderate COVID-19 and 10 healthy controls) 
were enrolled at 2 clinical sites in the US beginning in July 2021 and completing follow-
up in January 2022. The age of participants ranged from 18 to 90 years in the COVID-19 
group (57.7% female) and from 18 to 53 years in the Control group (60% female). 
Median age in both groups was 30 years. In the COVID-19 group, 18 of 52 participants 
(34.6%) had previously received COVID-19 vaccine; 7 of 10 in the Control group 
(70.0%) had previously been vaccinated for the disease. The days from last vaccine dose 
to enrollment ranged from 21 to 319 days (median 236.5) in the COVID-19 group and 
from 71 to 305 days (median 193) in the Control group. 
Regarding accuracy of Tasso sample against venous sample: control group participants 
were uniformly antibody positive at all visits in tests performed with venous whole blood 
or Tasso whole blood. For COVID-19 group participants, 27/48 (56.2%) were positive on 
Day 1, with progressive increases in positivity rate at each visit to 48/49 (98.0%) on 
Day 29. Similar results were obtained using Tasso whole blood, but the antibody 
positivity rate and median antibody cutoff values were lower with Tasso whole blood 
than with venous whole blood (Table 3). 
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Table 3 
Summary of LightDeck Antibody Results (Venous Whole Blood vs 
Tasso Whole Blood) (JPEO-003, Summary of Results, 2022) 
 
COVID-19 group (n=49) 
Control group (n=10) 
Day 1 
Day 4 
Day 8 
Day 1 
Day 4 
Day 8 
Number of Tests Run, n (%) 
48 (98.0) 
10 (100.0) 
Venous Whole Blood, n (%) 
Negative (non-reactive) 
21 
(43.8) 
14 
(28.6) 
5 
(10.4) 
0 
(0.0) 
0 
(0.0) 
0 
(0.0) 
Positive (reactive) 
27 
(56.3) 
35 
(71.4) 
43 
(89.6) 
10 
(100.0) 
10 
(100.0) 
10 
(100.0) 
TASSO Whole Blood, n (%) 
Negative (non-reactive) 
21 
(43.8) 
17 
(35.4) 
7 
(14.3) 
0 
(0.0) 
0 
(0.0) 
0 
(0.0) 
Positive (reactive) 
27 
(56.3) 
31 
(64.6) 
42 
(85.7) 
10 
(100.0) 
10 
(100.0) 
10 
(100.0) 
Regarding safety, 4 total participants (6.5%) from the COVID-19 group (3 of 
52 participants [5.8%]) and the Control group (1 of 10 participants [10%]) experienced 
solicited adverse events (AEs). In more detail, 2 participants experienced mild skin 
irritation from the monitoring skin patch, which resolved without sequelae; 1 participant 
had a severe paranasal sinus discomfort; and 1 participant had severe chills. To note, the 
later 2 AEs (chills and paranasal sinus discomfort) were not considered to be related to 
the study procedures, as per the site investigator. There were no SAEs in the study. All 
solicited treatment-emergent AEs (TEAEs) were of mild or moderate severity except for 
one from the COVID-19 group, which was rated as severe by the investigator. There 
were no severe or life-threatening AEs. No subjects discontinued the study due to AEs, 
and no concomitant medications were needed to treat any AEs. No participant had AEs 
that were considered to be related to study treatment. There were no SAEs, medically 
attended AEs, or pregnancies reported.  
Currently, the third generation of Tasso+™ is being used as an FDA 510(k)-cleared 
Class II medical device. Based on an e-mail communication with Tasso, from June to 
August 2023, more than 40,000 third generation Tasso+™ devices have been utilized. 
Overall, during this period, the following customer feedback has been compiled 
regarding the use of the Tasso+™ device: no blood collected (n=8); insufficient volume 
collected (n=6), bruising (n=4); failure in lancet activation (n=4); scarring (n=2); device 
damaged (n=1); poor adhesive, device fell off arm (n=1) (Tasso personal 
communication). 
Recently, HJF performed an institutional review board (IRB)-approved 
(PC09_WCG20226038) evaluation of the second-generation Tasso+™ devices entitled 
“Comparison of collection of venipuncture blood vs. mild vacuum pressure collection 
devices on studies of plasma, serum, whole blood, and cellular derivatives.” This protocol 
enrolled 10 subjects during April and May 2023 for 2 encounters (2 Tasso+™ second 
generation devices per encounter) under supervision. The two encounters were 42 days 
apart. In this study, the Tasso+™/LH collection kits were used with the Tasso+™ 
devices. Four of ten subjects reported scarring up to 28 days from the first visit, and 
1 subject reported bruising after the first visit. Approximately 50% of the collected 
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samples showed evidence of clotting. A majority of the subjects reported their preference 
for Tasso blood collection versus venipuncture (HJF personal communication). 
1.2 
Study Rationale 
COVID-19 demonstrated the potential of pandemics to overwhelm local and state 
medical infrastructures to diagnose and treat patients, while attempting to minimize 
further transmission risks to the un-infected. Furthermore, the COVID-19 pandemic has 
impacted the conduct of clinical trials of medical products, leading to challenges in 
meeting protocol-specified procedures, including adhering to protocol-mandated visits 
and laboratory/diagnostic testing. Overall, the emergence of DCTs may help improve 
trial participant engagement, recruitment, enrollment, and retention of a meaningfully 
diverse clinical population. 
Enabling technologies that would enable the collection of blood and other diagnostic 
samples at the point-of-care by the patient/participant while at a remote location could 
potentially offer several benefits, eg, improved patient/participant convenience and 
comfort, early diagnostic sampling (and thereby potentially early diagnosis), greater 
participant study compliance (especially for pharmacokinetic and biomarker research 
endpoints), relief of phlebotomy-related bottlenecks while reducing any potential 
transmission risks. 
Advancing technologies that can enable blood collections by the patient or study 
participant while remaining at a remote location provide a potentially attractive 
alternative for patients who are not critically ill. These technologies have the potential to 
minimize transmission-risk and accelerate the timeline for diagnosis and treatment. 
Furthermore, this would allow for the better channeling of potentially limited medical 
resources (eg, phlebotomists, HCP) toward managing a pandemic response. In a clinical 
trials’ setting, this may be more attractive to study participants, sparing them the need for 
frequent clinic visits, and would reduce the overall costs associated with frequent clinic 
visits. 
Enabling such self-collection devices has the potential to take the initial evaluation of a 
patient closer to the point-of-care, supporting telemedicine strategies and virtual clinical 
trials. Advancing such innovative technologies requires that device performance and user 
experience be compared to the current standard of care offered by in-clinic HCPs. 
Examples of Tasso device use for SARS‑CoV‑2 antibody testing have been published in 
the literature. In one study, the use of Tasso device for capillary blood self-collection was 
associated with a high success rate (93.4% of participants in unsupervised settings and 
94.5% of participants in supervised settings) and an excellent concordance (overall 
accuracy of 98.9%) for anti-SARS‑CoV‑2 IgG results when compared to standard venous 
blood-derived sera (Hendelman et al., 2021). In another study, 70.0% of participants were 
able to collect an adequate sample for testing using the Tasso device. Among those with 
an adequate sample, there was a high concordance in results between the Tasso/SST and 
phlebotomy blood collection methods (Cohen’s kappa coefficient = 0.88). Moreover, the 
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Tasso device receives a high-level (90.0%) of acceptance among all participants (Wixted 
et al., 2022). To note, the higher failure rate (30.0%) observed by Wixted et al., (2022) 
compared to the failure rate of 6.6% observed by Hendelman et al., (2021) could be due 
to an older population (median age and range of 58.0 years [45.0 to 68.0 years] vs 
45 years [21 to 73 years]), in which manual dexterity or comorbidities could be more 
likely to affect use of the device.  
The Tasso+™ lancet is an enabling technology that is an FDA 510(k)-cleared Class II 
medical device that aims to improve upon the traditional venipuncture blood collection 
experience. This study aims to evaluate the third generation Tasso+™ device with 
Tasso+™/SST and Tasso+™/EDTA collection kits with respect to device performance 
and user experience in adult participants who are healthy or in well-compensated health. 
The Tasso+™/SST collection kit will be used to evaluate serum while the 
Tasso+™/EDTA collection kit will be used to evaluate whole anticoagulated blood and 
plasma. 
The laboratory results of Tasso+™/SST capillary collection tube will be compared on 
Day 1 to blood collected using the standard venipuncture by an HCP across an array of 
laboratory tests being tested by laboratory technicians at a single central laboratory 
(Table 4). 
Establishing correlation coefficients of laboratory results collected by a study participant 
and compared to standard venipuncture will be an important milestone to rely solely on 
the patient/study participant to self-collect blood using either device/kit collected and to 
ship the samples to a designated laboratory. Indeed, in a recent study, even though 
Tasso/SST serum protein measurements were highly reproducible, self-collection at 
home with delayed sample processing was associated with significant concentration 
differences for several analytes compared to supervised, in-clinic collection with rapid 
processing (Brandsma et al., 2022). These results are to be compared to higher 
concordance results obtained among other studies focusing on serology: overall accuracy 
of 98.9% in the study conducted by Hendelman et al., (2021) and Cohen’s kappa 
coefficient of 0.88 in the study conducted by Wixted et al., (2022). 
The sample integrity of Tasso+™/SST (ie, adequate volume and absence of moderate or 
gross hemolysis) and Tasso+™/EDTA (ie, adequate volume, absence of moderate or 
gross hemolysis, and absence of clotting) capillary collection tubes will be evaluated on 
Day 1 for each cohort and on each of Days 29 and 57 for Cohorts A and B combined 
(Table 4). 
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Table 4 
Sample Testing Table 
Method of blood 
collection 
Laboratory Results 
Sample Integrity 
SARS-CoV-2 
Chemistry* 
Sample 
Volume 
Hemolytic 
Index 
Clotting 
Tasso+™ 
device 
EDTA 
9 
 
9 
9 
9 
SST 
9 
9 
9 
9 
 
Venipuncture  
EDTA 
9 
 
 
 
 
SST 
9 
9 
 
 
 
EDTA=ethylenediaminetetraacetic acid; SST=serum separator tube 
Footnotes: Chemistry analytes include sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and 
C-reactive protein. 
There will be no complete blood count laboratory analysis using Tasso+™/EDTA capillary collection tube due to potential for red cell 
lysis and clotting, and insufficient blood volume collection that may preclude accurate results. 
The impact of the timing of centrifugation after blood collection with Tasso+™ on blood 
sample integrity and accuracy will be evaluated on Day 1, as Tasso+™ blood samples of 
Cohort A participants will be centrifuged after shipping to the Central Laboratory, while 
Tasso+™ blood samples of Cohort B participants will be centrifuged and aliquoted by 
the Site prior to being shipped to the Central Laboratory alongside with venipuncture 
blood samples that will be centrifuged prior to shipping as per standard procedures. 
Subsequent Tasso+™ administrations will be conducted remotely by the study participant 
to further document the device performance and user experience. Participants will receive 
proctor-support from the Site on Day 29 (and if requested, on Day 57). The results of this 
study may provide data to ensure the feasibility of decentralized, blood collections, thus 
supporting telemedicine strategies and virtual clinical trials. 
1.3 
Benefit/Risk Assessment 
Risks to study participants include pain, tenderness, redness, swelling, bruising, and 
persistent bleeding at the puncture site, as well as dizziness, and fainting, that is also 
occasionally experienced with venipuncture. There is also a slight risk of infection and 
scarring. 
Additionally, collection of upper respiratory fluid using a nasopharyngeal swab for the 
SARS‑CoV‑2 polymerase chain reaction (PCR) test may cause discomfort. 
Study participants will self-collect blood using the Tasso+™ following appropriate 
training/instructions (including remote support from a proctor) to complete the 
administration successfully while minimizing any potential risks associated with the use 
of Tasso+™ device. Contact information will be provided to each participant in the event 
they have concerns or need help while using the Tasso+™ device. 
There are no direct benefits to participants in this study. However, information collected 
from this study may be used to improve remote testing and/or diagnostics and to develop 
telemedicine, thus benefiting ill patients during future pandemics and study participants 
enrolled in DCTs. 
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In conclusion, considering the measures planned to minimize risks to study participants, 
any potential risks associated with the use of the Tasso+™ device are justified by the 
anticipated benefits afforded by telemedicine. 
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2 STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective is to assess the Tasso+™ performance (sample integrity, testing 
accuracy, and reliability). 
2.2 
Secondary Objectives 
The secondary objectives are to evaluate Tasso+™ user experience (safety, tolerability, 
and usability) and to perform surveillance for SARS‑CoV‑2 infection. 
2.3 
Exploratory Objective 
To evaluate the impact of prior training on subsequent Tasso+™ administrations. 
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3 STUDY ENDPOINTS 
3.1 
Primary Endpoints 
The primary endpoints that will be evaluated to assess the Tasso+™ blood collection 
device performance are as follows: 
Sample integrity 
x Percentage of overall Tasso+™/SST samples collected that are with adequate 
volume and without moderate or gross hemolysis on Day 1 for each cohort and on 
each of Days 29 and 57 for Cohorts A and B combined  
x Percentage of overall Tasso+™/EDTA samples collected that are with adequate 
volume, without moderate or gross hemolysis, and without clotting on Day 1 for 
each cohort and on each of Days 29 and 57 for Cohorts A and B combined  
Testing accuracy 
x Correlation of SARS-CoV-2 serology between venipuncture and Tasso+™/SST 
or Tasso+™/EDTA samples on Day 1 for each cohort 
x Correlation of each chemistry analyte between venipuncture and Tasso+™/SST 
samples on Day 1 for each cohort 
Reliability 
x Percentage of Tasso+™ device failures from Day 1 to Day 57 (see details in 
Section 6.3.3), defined as: 
o failure in activation of the lancet;  
o lack of any blood collection within 5 minutes;  
o incorrect attachment of the capillary collection tube to the device;  
o damage to the device or the capillary collection tube upon handling;  
o lack of maintained seal between the device and the skin surface of the 
participant; or  
o incomplete trigger of the button (not fully pressing the button once the 
Tasso+™ device is sealed to the skin surface). 
3.2 
Secondary Endpoints 
The secondary endpoints that will be evaluated to assess the Tasso+™ user experience 
and to perform a surveillance study for SARS‑CoV‑2 infection are: 
Safety 
x Percentage of eligible participants who experience solicited local AEs including 
pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ 
administration 
x Percentage of eligible participants who experience unsolicited AEs within 28 days 
of Tasso+™ administration 
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x Percentage of eligible participants who experience a related Grade 3 AE, a related 
Grade 4 AE, a related AE leading to discontinuation, or a related SAE within 
28 days of Tasso+™ administration 
Tolerability 
x Percentage of eligible participants who complete last Tasso+™ administration 
(Day 57) 
Usability 
x Ease of use as assessed by the participant completing the Tasso questionnaire 
immediately following administration (on Days 1, 29, and 57) and on Day 85 
SARS‑CoV‑2 infection surveillance 
x Percentage of eligible participants with a positive nasopharyngeal swab for 
SARS‑CoV‑2 PCR on Day 1 
x Percentage of eligible participants seroconverting to SARS-CoV-2 between 
Days 1 and 57 
3.3 
Exploratory Endpoint 
The exploratory endpoint will evaluate the impact of prior training on subsequent 
Tasso+™ administrations using descriptive analyses of proctor-supported and proctor-
unsupported Tasso+™ administrations on Day 57 using each of the following endpoints: 
x Sample integrity 
x Reliability 
x Safety 
x Usability 
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4 STUDY PLAN 
4.1 
Overall Study Design and Plan 
This is a Phase 1, multicenter, observational study that will evaluate the Tasso+™ device 
in approximately 200 male or female adult participants in an outpatient setting who are 
healthy or in well-compensated health at up to 5 US sites.  
The Investigator will obtain electronically signed informed consent (eConsent form) from 
the participant before any study procedures are performed. For further details regarding 
the informed consent process, see Section 11.3. 
Each participant will be followed with a study visit in the Clinic on Day 1, and 
subsequent decentralized, remote study visits on Days 29, 57, and 85. The total duration 
of study participation is expected to be 85±3 days. 
On Day 1, each participant will be randomized 2:1 to either Cohort A or Cohort B. 
Tasso+™ blood samples of participants randomized to Cohort A will be shipped to the 
Central Laboratory where they will be centrifuged and aliquoted. However, Tasso+™ 
blood samples of participants randomized to Cohort B will be centrifuged and aliquoted 
at the Site prior to shipping to the Central Laboratory, following the same approach used 
for venipuncture blood samples. 
The decentralized visit on Day 29 (Visit 2) will be remotely supported by a prescheduled 
proctor during working hours to support the participant’s self-administration of the 
Tasso+™ device. For the decentralized visit on Day 57 (Visit 3), the participant will have 
the option to request a prescheduled proctor session during working hours to support the 
participant’s self-administration of the Tasso+™ device. 
The participant will use an electronic diary (eDiary) to report symptoms for 28 days 
following each Tasso+™ device administration (Symptom questionnaire) and to report 
on the usability of the Tasso+™ device (Tasso questionnaire) immediately following 
each Tasso+™ device administration (on Days 1, 29 and 57) and on Day 85. Contact 
information will be provided to each participant in the event they have concerns or they 
need help during working hours while using the Tasso+™ device. 
Venous blood collection (phlebotomy) will take place on Day 1; capillary blood 
collections using Tasso+™ device will take place on Days 1, 29, and 57; usability data 
will be collected after each use of Tasso+™ device and on Day 85; reliability of the 
device will be collected after each use of Tasso+™ device (Days 1, 29, and 57).  
Each Tasso+™ capillary blood collection will be followed by a 28-day follow-up period 
during which safety of the Tasso+™ device will be assessed using an eDiary (Symptom 
questionnaire). Solicited symptoms will be assessed for the first 7 days following each 
Tasso+™ administration, while unsolicited AEs will be captured for the full 28-day 
period after each administration. 
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Each self-collected Tasso+™ blood sample will be assessed for sample integrity by the 
Central Laboratory. Moreover, on Day 1, the self-collected capillary blood sample will be 
compared to a venous blood sample collected by an HCP, in order to assess device 
performance. 
Each participant will receive nasopharyngeal swabbing on Day 1 for SARS-CoV-2 PCR 
testing to identify any baseline SARS-CoV-2 infections. The nasopharyngeal swab will 
be performed and resulted by the Site. Participants with positive results may remain on 
study but will be referred to their primary physician for COVID-19 management. During 
the study, if participants experience any COVID-19 symptoms or if they became 
COVID-19 positive, they are to be reported to the Investigator via provided Site’s phone 
number. Management of COVID-19 positive participants is detailed in Section 4.4. 
SARS‑CoV‑2 antibody testing (Days 1 and 57) will be conducted to serologically 
identify intervening COVID-19 cases, or if in the absence of intervening symptoms, 
SARS‑CoV‑2 infections. 
The Study Schematic and Schedule of Assessments are available in Figure 1 and Table 1 
respectively. 
See Section 7.4 for an overview of instruction for use (IFU) of Tasso+™ device. The 
detailed IFU will be provided in a separate document. 
4.2 
Steps to the Process 
4.2.1 
Training 
Training will be provided on Days 1 and 29 and will include detailed IFU and online 
video training. The detailed IFU will be provided in a separate document, and an 
overview of IFU is provided in Section 7.4. When administering the Tasso+™ remotely, 
participants will receive proctor-support from the Site on Day 29 (and as requested, on 
Day 57) during working hours, the intent being to guide the participant through the 
process and to help troubleshoot should any difficulties be encountered. Training on 
Day 57 should be performed only if it is specifically requested due to participant 
hesitation. 
4.2.2 
Blood Collection 
Once trained, and by following the IFU provided (see Section 7.4), participants will self-
administer the Tasso+™ device in the Clinic at the Investigator site (supervised) and 
subsequently remotely, ie, at home or a suitable remote location (proctor-supported on 
Day 29 and unsupported on Day 57). Self-collection may be additionally supported on 
Day 57 using a proctor session, as requested, to guide the participant through the process 
and help to troubleshoot any difficulties. The SST tube will be preferably collected from 
the left upper arm and the EDTA tube will be preferably collected from the right upper 
arm. 
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As per IFU, participants will have to gently invert the Tasso+™ capillary collection tubes 
after the full collection process is completed. 
4.2.3 
Blood Volume and Clotting Analyses 
Blood volume and clotting analyses will be assessed before centrifugation. Thus, for 
Cohort B, on Day 1, these endpoints will be assessed by the Site, while for Cohort A, on 
Day 1 and for Cohorts A and B combined on Days 29 and 57, these endpoints will be 
assessed by the Central Laboratory (see Section 6.3). 
4.2.4 
Centrifugation 
Tasso+™ blood samples of participants randomized to Cohort A, collected on Day 1, will 
be centrifuged upon receipt by the Central Laboratory, as per the real-world use of 
Tasso+™. 
Tasso+™ blood samples of participants randomized to Cohort B, collected on Day 1, will 
be centrifuged and aliquoted by the Site before shipping, following the same procedure as 
for venipuncture blood samples. 
Tasso+™ blood samples of participants from both Cohorts A and B, collected on 
Days 29 and 57, will be centrifuged upon receipt by the Central Laboratory, as per the 
real-world use of Tasso+™. 
Thus, for Cohort B, on Day 1, centrifugation and aliquoting will be performed by the 
Site, while for Cohort A, on Day 1 and for Cohorts A and B combined on Days 29 and 
57, centrifugation and aliquoting will be performed by the Central Laboratory. 
4.2.5 
Shipping 
On Day 1, Tasso+™ and venipuncture collection tubes will both be shipped by the Site 
following this visit. 
On Days 29 and 57, blood will be shipped by the participant (remotely proctor-supported 
and unsupported, respectively). 
4.2.6 
Hemolysis Analysis 
Hemolytic index will be assessed before testing by the Central Laboratory (see 
Section 6.3). 
4.2.7 
Testing 
Upon receipt, both SST and EDTA samples will be tested by Central Laboratory (see 
Section 6.3). 
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4.3 
Management of Device Failures 
Device failures, as a measure of reliability, will be assessed, as part of evaluating device 
performance.  
Device failures due to deficiencies or malfunctions (see Sections 8.1.6 and 8.1.7) are 
defined as failure in activation of the lancet, or lack of any blood collection within 
5 minutes.  
Device failures due to user errors (see Sections 8.1.8) consist of incorrect attachment of 
the capillary collection tube to the device, damage to the device or the capillary collection 
tube upon handling, lack of maintained seal between the device and the skin surface of 
the participant, or incomplete trigger of the button (not fully pressing the button once the 
Tasso+™ device is sealed to the skin surface) (see Section 6.3.3 for details).  
On a case-by-case basis, in the event of collection failure, either related to user or device, 
as per the protocol-specific laboratory manual, an additional device/kit may be provided 
to the participant, so that proctor-supported or unsupported capillary blood collection can 
be performed for a second time, 1‑inch away from the previous administration site. 
A proctor session may be triggered by the participant (during working hours) in order to 
claim for help or report any concern related to the unsupported use of Tasso+™ device. 
Contact information will be provided to each participant in the event they have concerns 
or they need help while using Tasso+™ device. 
In the event of collection failure, the participant should contact the Site for instructions 
on how the device should be returned to the clinic for evaluation. 
4.4 
Management of COVID-19 Positive Participant 
According to the Center for Disease Control and Prevention (CDC), people with 
COVID‑19 have had a wide range of symptoms reported – ranging from mild symptoms 
to severe illness. Symptoms may appear 2-14 days after exposure to the virus. Symptoms 
may include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, 
muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or 
runny nose, nausea or vomiting, diarrhea (CDC, 2022). 
On screening, any participant who tests positive for SARS-CoV-2 PCR will be permitted 
to continue study participation. However, the Investigator will assess for the presence of 
any symptoms of COVID-19 and will refer the participant to their primary physician if 
the participant is symptomatic. 
In the event that a participant seroconverts to SARS-CoV-2 between Day 1 and Day 57, 
the participant will be assessed as to whether any symptoms of COVID-19 had been 
experienced during the intervening period. This will distinguish SARS-CoV-2 infection 
from COVID-19 (see Section 6.3.7). Medical costs associated with COVID-19 will not 
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be covered by the Sponsor. The site staff will not be expected to treat participants for 
COVID-19 symptom management. 
4.5 
End of Study 
The end of the study is defined as the date the last participant receives final assessment. 
4.5.1 
Completion 
A participant is considered to have completed the study if he/she has completed all study 
visits. 
4.5.2 
Discontinuation 
Participants will be discontinued by the investigator if: 
x participant is hospitalized due to COVID-19. 
x participant develops an illness that would interfere with his/her continued 
participation in the study. 
x participant experiences a related AE leading to study discontinuation. 
x participant experiences a related Grade 3 AE, a related Grade 4 AE, or a related SAE 
that may interfere with the participant’s study involvement. 
x participant is noncompliant with study procedures, in the opinion of the Investigator. 
x participant is lost to follow-up (ie, who misses more than 1 visit or fails to complete 
the eDiary for more than 7 consecutive days without justification).  
x any other reason relating to the participant’s safety or integrity of the study data. 
Discontinued participants meeting the above criteria will not be replaced. If a participant 
is discontinued from the study early, the assessments planned for the last follow-up/end 
of study Visit should be completed at the time of discontinuation. 
4.5.3 
Withdrawal 
Participants can terminate their study participation at any time without prejudice. If 
participation termination occurs before completing the study, the reason for this decision, 
if provided, will be recorded in the study notes. 
Participants who withdraw from the study will not be replaced. 
A participant will be considered withdrawn if consent is withdrawn prior to the 
completion of the last follow-up/end of study Visit. If a participant withdraws from the 
study early, the assessments planned for the last follow-up/end of study Visit should be 
completed at the time of withdrawal. 
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4.5.4 
Study Halting Criteria 
Study activities will be halted at any time if medically indicated. Study activities must be 
stopped, and a review of available safety data will be evaluated if the following occur: 
x Malfunction of the device resulting in unexpected severe harm to any participant. 
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5 STUDY POPULATION 
A total of approximately 200 eligible participants will be enrolled at up to 5 clinical sites 
in the US. Participants must meet all of the inclusion criteria and none of the exclusion 
criteria to be participating in the study. 
5.1 
Inclusion Criteria 
The following inclusion criteria must be met for a participant to be eligible for 
participating in the study: 
1. Male or female adults (18 years of age or older, inclusive), at the time of informed 
consent. Participants who are deemed pregnant by urine pregnancy test at Screening 
remain eligible. 
2. Able to understand and willing to provide informed consent and able to comply with 
the study procedures and restrictions. 
3. Participant considered healthy or in well-compensated health according to medical 
history, concomitant medications, and physical examination (including vital signs). 
5.2 
Exclusion Criteria 
A participant who meets any of the following exclusion criteria will not be eligible for 
participating in the study: 
1. Medical history, or physical examination (including vital signs) findings, that suggest 
to the Investigator that the participant has undiagnosed or untreated medical 
condition(s) that could confound the AE evaluation and thereby undermine the study 
objectives. 
2. Any known medical history of infection with HIV (CD4<200 and/or detectable viral 
load within the prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive 
hepatitis C virus antibody). 
3. Chronic illness for which a participant’s immune system is suspected by the 
Investigator to be impaired or altered, such as cancer, autoimmune conditions, and 
diabetes. 
4. Participation in another investigational study within 30 days of time of consent or 
plans to do so during the course of this study. 
5. Large tattoos or skin eruptions overlying either of the deltoid muscles that could 
confound the monitoring for local reactogenicity following Tasso+™ administrations. 
6. Use of systemic immunomodulatory therapy, including oral corticosteroids, within 
the past 6 months; or planned use of medications or nutritional supplements known to 
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or which potentially could affect organ function within 30 days prior to screening 
until end of study. 
7. Acute illness within 14 days prior to device use unless it is determined by the 
Investigator that the illness is mild in severity and unlikely to progress. 
8. Of limited legal capacity. 
9. Any condition (including suspected alcohol- or drug-related addiction) that precludes 
adequate understanding, cooperation, and/or compliance with study procedures or any 
condition that could pose a risk to the participant’s safety per Investigator judgment. 
5.3 
Screen Failures 
Subjects who do not meet 1 or more criteria required for eligibility will not be enrolled in 
the study. A minimal set of screen failure information is required to ensure transparent 
reporting of screen failure participants, to meet the Consolidated Standards of Reporting 
Trials publishing requirements, and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure details, eligibility criteria, and 
any SAE. 
Individuals who are reported under screen failures, because of acute illness 
(exclusion criterion #7), may be rescreened 14 days after recovery of acute illness. 
5.4 
Premature Withdrawal/Discontinuation from the Study 
Participation in the study is strictly voluntary. A participant has the right to withdraw 
from the study at any time for any reason, without any reprisal. 
The Investigator/Sponsor has the right to discontinue a participant from the study for any 
of the following reasons: 
x The participant is hospitalized due to COVID-19. 
x The participant develops an illness that would interfere with his/her continued 
participation in the study. 
x The participant experiences a related AE leading to study discontinuation. 
x The participant develops a related Grade 3 AE, a related Grade 4 AE or a related SAE 
that may interfere with the participant’s study involvement. 
x The participant is noncompliant with study procedures, in the opinion of the 
Investigator. 
x The participant is lost to follow-up (ie, who misses more than 1 visit or fails to 
complete the eDiary for more than 7 consecutive days without justification).  
x The regulatory agency requests withdrawal of the participant. 
x Any other reason relating to the participant’s safety or integrity of the study data. 
If a participant is discontinued from the study, the study monitor/Sponsor will be 
informed immediately. If there is a medical reason for discontinuation, the participant 
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will be referred to their primary physician, if warranted, for clinical management. The 
participant will be requested to inform the Investigator of their clinical progress. 
If the participant withdraws consent for disclosure of further information, the Sponsor 
may retain and continue to use any collected data before such a withdrawal of consent. If 
a participant withdraws from the study, he/she may request destruction of any samples 
taken and not tested, and the Investigator must document this in the site study records. 
Although a participant is not obliged to give his/her reason(s) for withdrawing 
prematurely from a study, the Investigator should make a reasonable effort to ascertain 
the reason(s), while fully respecting the participant’s rights. 
At the time of premature study discontinuation, the Investigator should make every effort 
to ensure the participant completes the assessments indicated at the end of study Visit; 
see Table 1. 
Participants who prematurely discontinue from the study cannot subsequently rejoin the 
study. 
For details on the discontinuation of clinical sites or the study as a whole, see Section 15. 
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6 DESCRIPTION OF STUDY PROCEDURES AND ASSESSMENTS 
A detailed schedule of study procedures and assessments is provided in Schedule of 
Assessments (Table 1). 
6.1 
Recruitment/Screening Visit 
6.1.1 
Recruitment 
A detailed schedule of study procedures and assessments is provided in Schedule of 
Assessments (Table 1). 
Potentially interested individuals to be recruited by clinical sites for potential study 
enrollment: 
x Presenting for routine diagnostic testing 
x Referred by their healthcare provider 
x Review of records at the clinical sites 
x Recruitment messaging through social media and other printed or electronic 
advertising (communication materials to be approved by the IRB prior to 
implementation). 
6.1.2 
Informed Consent 
Each participant will electronically sign an eConsent form before any study-related 
procedures takes place. This includes sample collection; any sample used for the purpose 
of the study cannot be obtained before the participant has consented to the study.  
The objective of the study will be explained to the participant during their Day 1 Visit 
(Table 1). After these explanations, the participant has an opportunity to review the 
eConsent form and ask questions before deciding to participate in the study and before 
being asked to electronically sign an IRB‑approved eConsent form prior to conduct of 
any study procedures. Then, demographics, medical history, vital signs, physical 
examination, and eligibility will be assessed, if deemed eligible for the study participation 
(see Sections 5.1 and 5.2). 
6.1.3 
Demographics 
Demographic data, including year of birth/age, sex, and race, will be recorded in the 
eCRF. 
6.1.4 
Medical History 
A brief relevant medical history (notably within the past 5 years), including any ongoing 
illnesses, as well as COVID-19 illness/vaccine history, will be collected from participants 
to assess whether any concurrent medical condition may impact assessment of COVID-
19 symptoms (eg, active, significant pulmonary disease) or pose additional risk for 
participation in the study. Any ongoing illness/condition will be recorded in the eCRF, 
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with the start date and stop date (if applicable, with at least a year recorded if no exact 
date) of the illness/condition. 
Any relevant pre-study procedures (notably within the past 5 years) will be recorded in 
the eCRF as part of the medical history assessment. 
6.1.5 
Vital Signs 
Participants will undergo vital signs assessment, as indicated in the Schedule of 
Assessments (Table 1). 
Heart rate, systolic and diastolic blood pressure, respiratory rate, SpO2 by pulse oximetry, 
and body temperature will be measured. Heart rate and blood pressure measurements 
should be taken in the supine position and preceded by at least 5 minutes of rest. 
6.1.6 
Physical Examination 
Participants will undergo physical examination, as indicated in the Schedule of 
Assessments (Table 1). 
The complete physical examination will include assessments of the standard physical 
examination items, including general appearance, skin, eyes, ears, nose, throat, head and 
neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, 
neurological, and other body systems, if applicable, for describing the status of the 
participant’s health. 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. Any new abnormalities or worsening of existing abnormalities should be 
reported as AEs, as appropriate (see Section 8). 
6.1.7 
Pregnancy Test 
At Screening, female participants will perform a urine pregnancy. Regardless of the test 
result (positive or negative), the participant will remain eligible for study participation. 
Thus, the participant will remain eligible in case of positive pregnancy test. However, 
medical costs associated with the pregnancy will not be covered by the Sponsor, as the 
risk to participants has been considered non-significant (see Appendix II). 
6.1.8 
Identification 
At the screening, after eConsent form signature, a unique identification number will be 
assigned to each participant. The participant will be referenced by this ID throughout the 
study. The study manual of procedures describes the identification assignation in full. 
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6.2 
Study Visits (Days 1, 29, 57, and 85) 
The Day 1 Visit will occur at the clinical site and subsequent visits on Study Days 29, 57, 
and 85 will occur remotely. On Day 1, participants will be provided and trained on an 
eDiary that will allow them to record their symptoms (Symptom questionnaire) and 
usability (Tasso user questionnaire). The eDiary entries will be reviewed at each visit and 
any recorded symptoms will be entered into the electronic data capture (EDC) database. 
Participants will complete the user questionnaire (available in eDiary), provided by 
Tasso, immediately following each Tasso+™ device administration. The user 
questionnaire consists of questions about their user experience including assessing their 
willingness to use the Tasso+™ device repeatedly and at what frequency, any pain or 
discomfort experienced, their preference to venipuncture and finger-sticks, the ease of 
comprehension of the instructions and training, and the healing of the collection site. 
Venous blood will be obtained from participants at the clinical site on Day 1 using 
syringe or Vacutainers, as described in the Schedule of Assessments (Table 1). Heart rate 
and blood pressure measurements should be taken in the supine position, preceded by at 
least 5 minutes of rest. Body temperature will be taken by ear/tympanic/temporal, oral, or 
forehead method. 
Clinician supervised collection of blood using the Tasso+™ device will be performed at 
Day 1 Visit and collection of blood using the Tasso+™ device will be performed 
remotely on Day 29 (proctor-supported) and on Day 57 (intended to be unsupported). 
There will be two collections, one from each arm; left upper arm will be preferably used 
for serum preparation (Tasso+™/SST capillary collection tube with gold cap, see 
Table 2) and right upper arm will be preferably used to collect whole blood 
(Tasso+™/EDTA capillary collection tube with lavender cap, see Table 2). During 
Visits 2 and 3 (Days 29 and 57), Tasso+™ device will be self-administered by the 
participant. On Day 29, the self-collection will be supported by a proctor (during working 
hours). On Day 57, self-collection may be additionally supported by a proctor to guide 
the participant through the process and help to troubleshoot any difficulties (during 
working hours). Contact information will be provided to each participant in the event 
they have concerns or they need help while using Tasso+™ device. 
On Day 1, Tasso+™ and venipuncture collection tubes will both be shipped by the Site 
following this visit. 
On Day 29 and 57, blood will be remotely collected and shipped by the participant 
(proctor-supported and unsupported, respectively).  
Training will consist of a detailed IFU and online video training. The detailed IFU will be 
provided in a separate document, and an overview of IFU is provided in Section 7.4. In 
addition, when administering the Tasso+™ remotely, participants will receive proctor-
support on Day 29 (and as requested, on Day 57), during working hours, the intent being 
to guide the participant through the process and to help troubleshoot should any 
difficulties be encountered. While assistance will be available to the participant during 
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Day 57 Visit, it is of interest to know whether the prior trainings on Tasso+™ 
administration prove adequate for this subsequent administration. 
Nasopharyngeal swabs for qualitative and/or quantitative SARS-CoV-2 PCR will be 
performed and resulted by the Site. Nasopharyngeal swabs will be collected on Day 1 
according to the site’s standard operating procedures (SOP) and according to institutional 
and test kit manufacturer’s SOP or instructions and resulted by institutional laboratory. 
Specimen labels will include protocol number, participant ID number, and date of 
collection. 
6.3 
Endpoint Assessments 
Endpoint assessments should be completed as specified in Schedule of Assessments 
(Table 1). 
The primary objective of the study, which is the evaluation of Tasso+™ blood collection 
device performance, will be assessed with regards to sample integrity (see Section 6.3.1), 
testing accuracy (see Section 6.3.2), and reliability (see Section 6.3.3) of the device. 
The secondary objectives of the study, which are the evaluation of user experience and 
the surveillance for SARS‑CoV‑2 infection, will be assessed with regards to safety (see 
Section 6.3.4), tolerability (see Section 6.3.5), and usability (see Section 6.3.6) of the 
device as well as SARS‑CoV‑2 infection surveillance (see Section 6.3.7). 
6.3.1 
Sample Integrity 
Sample integrity of the Tasso+™ device, as part of device performance, will be evaluated 
as the percentages of Tasso+™/SST and Tasso+™/EDTA samples with adequate volume 
and without moderate or gross hemolysis, and the percentage of Tasso+™/EDTA 
samples without clotting. These endpoints will be assessed on Day 1 for each cohort and 
on each of Days 29 and 57 for Cohorts A and B combined. 
Blood collection volumes for Tasso+™ kits are ranging 400 to 600 μL for Tasso+™/SST 
kits and 250 to 500 μL for Tasso+™/EDTA kits. Adequate whole blood volume is 
defined as collected volume in accordance with the testing plan, ie, 300 μL. Desired 
volume is defined as adequate volume, which is doubled, ie, 600 μL, to allow retesting. 
The volume of blood collected with the Tasso+™ system will be measured in the Central 
Laboratory. 
As defined by Central Laboratory SOP, the absence or presence of hemolysis is defined 
using the hemolytic index (Table 5). Thus, absence of moderate or gross hemolysis is 
defined as a hemolytic index <2.00. 
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Table 5 
Impact of Varying Degrees of Hemolysis (Measured by Hemolytic 
Index) on Validity of Laboratory Results 
Degree of Hemolysis 
None 
Slight 
Moderate 
Gross 
Hemolytic Index 
<0.3 
≥0.3 and <2.0 
≥2.0 and ≤5.0 
>5.0 
Sodium 
No effect 
No effect 
No effect 
All results 
invalidated 
Potassium 
Potassium results 
invalidated 
Chloride 
No effect 
Blood urea nitrogen 
No effect 
Creatinine 
No effect 
Glucose 
No effect 
Phosphate 
Phosphate results 
invalidated 
Uric acid 
No effect 
C-reactive protein 
No effect 
SARS-CoV-2 serology 
No effect 
Presence or absence of clotting in the Tasso+™/EDTA samples will be assessed by 
Central Laboratory on samples collected on Days 1, 29, and 57. 
6.3.2 
Testing Accuracy 
Testing accuracy of the Tasso+™ device, as part of device performance, will be 
evaluated as (i) the correlation of SARS-CoV-2 serology between venipuncture and 
either Tasso+™/SST or Tasso+™/EDTA samples collected on Day 1; and (ii) the 
correlation of each chemistry analyte between venipuncture and Tasso+™/SST samples 
collected on Day 1. This endpoint will only be assessed on Day 1 for each cohort 
separately.  
Seroconversion will be evaluated using IgG Nucleocapsid assay. A total serum (SST) or 
plasma (EDTA) volume of 175 μL will be necessary to cover potential retesting, if 
needed. Any participant who is positive for IgG Nucleocapsid assay for either matrix 
(SST or EDTA), will be considered SARS-CoV-2 positive. 
The following chemistry analytes will be assessed for correlation between the two 
collection approaches (venipuncture and Tasso+™/SST) on Day 1: sodium, potassium, 
chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C‑reactive 
protein. 
Noteworthy, in case of long duration between sample collection and testing, there may be 
risks associated with inaccurate sodium, potassium, and glucose values. 
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If a sodium, potassium, or glucose level is determined by the PI to be possibly clinically 
significant, a venipuncture repeat of the test should be performed at the Investigator site 
for safety reasons. Testing will be performed by the Investigator site and will not be sent 
to the Central laboratory. 
6.3.3 
Reliability 
Reliability of the Tasso+™ device, as part of device performance, will be measured as 
the percentage of device failures (failures that either occur due to inherent faulty 
mechanism of the device or due to user error) from Day 1 to Day 57. This endpoint will 
be assessed by the participant through completion of the Tasso user questionnaire 
(available in eDiary) immediately following each Tasso+™ administration. 
A device failure due to a faulty mechanism consists of either: (i) failure in activation of 
the lancet; or (ii) lack of any blood collection within 5 minutes (see Section 7.4). 
A device failure due to user error consists of either: (i) incorrect attachment of the 
capillary collection tube to the device; (ii) damage to the device or the capillary collection 
tube upon handling; (iii) lack of maintained seal between the device and the skin surface 
of the participant; or (iv) incomplete trigger of the button (not fully pressing the button 
once the Tasso+™ device is sealed to the skin surface) (see Section 7.4). 
x 
An unscheduled kit may be used by the participant to re-attempt the 
administration after reporting the issue to the study staff, following instruction of the 
protocol-specific laboratory manual. 
6.3.4 
Safety 
Safety of the Tasso+™ device, as part of user experience, will be evaluated as the 
percentages of eligible participants who: (i) experience solicited local AEs including 
pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration; 
(ii) experience unsolicited AEs within 28 days of Tasso+™ administration; (iii) 
experience a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study 
discontinuation, or a related SAE within 28 days of Tasso+™ administration. This 
endpoint will be assessed throughout the conduct of the study. 
Severity and causality definitions are provided in Section 8.2. 
6.3.5 
Tolerability 
Tolerability of the Tasso+™ device, as part of user experience, will be evaluated as the 
percentage of eligible participants who complete last Tasso+™ administration (Day 57). 
6.3.6 
Usability 
Usability of the Tasso+™ device, as part of user experience, will be assessed using a 
Tasso questionnaire filled in the eDiary by participants immediately following each 
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Tasso+™ administration (on Days 1, 29, and 57) and on Day 85. The questionnaire 
includes questions about user experience, by assessing willingness to use Tasso+™ 
device again, the pain and discomfort experienced, the preference, the understanding of 
instructions, and the healing of the collection site hit. 
6.3.7 
SARS‑CoV‑2 Infection Surveillance 
SARS‑CoV‑2 infection surveillance will be performed by assessing the percentages of 
eligible participants with: (i) a positive nasopharyngeal swab for SARS-CoV-2 PCR on 
Day 1 and (ii) seroconverting to SARS-CoV-2 between Days 1 and 57. 
6.4 
Safety Assessments 
6.4.1 
Adverse Events 
AEs will be followed, recorded, and reported in line with the procedures described in 
Section 8. 
6.4.2 
Pregnancy 
Urine pregnancy tests will be performed for participants of childbearing potential on 
Day 1 as per Schedule of Assessment (Table 1). Regardless of the test result (positive or 
negative), the participant will remain eligible for study participation. The Investigator 
will record pregnancy information on the appropriate form and submit it to the Principal 
Investigator (PI) within 24 hours of the Day 1 Visit. Medical costs associated with the 
pregnancy follow-up will not be covered by the Sponsor, as the risk to participants has 
been considered non-significant (see Appendix II). 
6.4.2.1 
Pregnant Trial Participant (Incidental Pregnancy) 
If a participant becomes pregnant, the participant will not be discontinued from the study. 
The Investigator will record pregnancy information on the appropriate form and submit it 
to the PI within 24 hours of learning of the participant’s pregnancy. Medical costs 
associated with the pregnancy follow-up will not be covered by the Sponsor, as the risk to 
participants has been considered non-significant (see Appendix II).  
6.4.2.2 
Pregnant Partner of a Trial Participant 
In the event that the female partner of a male participant becomes pregnant, inclusion of 
the female partner into the study for safety assessment is not relevant for this Class II 
medical device, as the risk to participants has been considered non-significant (see 
Appendix II). Medical costs associated with the pregnancy will not be covered by the 
Sponsor.  
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6.4.3 
Breastfeeding 
Safety assessment of breastfed children is not relevant for this Class II medical device as 
the risk to participants has been considered non-significant (see Appendix II). 
6.5 
Sample Collection Storage 
The remnants of biological samples from clinical trial participants will be stored by the 
Central Laboratory, for the duration of the study, in case any retesting is required. After 
completion of all protocol-specified testing (ie, after database lock), Central Laboratory 
will not maintain the biological samples any further. 
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7 INTERVENTIONS 
7.1 
Investigational Medical Device 
Tasso kits which contain Investigational Medical Device will be shipped to the Sites by 
Central Laboratory in ICON kit boxes labeled “Exclusively for clinical trial”; no 
components in ICON kit boxes are investigational. 
7.1.1 
Description of Investigational Medical Device 
Tasso+™ device is a sterile, disposable, integrated capillary blood collection device, 
including a lancet assembly and a detachable capillary collection tube for the collection 
of blood by a user or caregiver in remote settings. The device is designed to collect 
within 5 minutes up to 600 μL capillary blood. The Tasso+™ device is comprised of the 
collection unit (called Tasso Button) and a capillary collection tube that can be supplied 
in several different configurations allowing the transportation of the blood. The Tasso+™ 
device lancet is classified as an FDA 510(k)-cleared Class II medical device in the US. 
The Tasso+™ device is designed to safely and reliably collect blood in clinical settings, 
without the need of a highly trained phlebotomist, while minimizing pain to the 
participant. Total volume of capillary blood collected by Tasso+™ per application will 
not exceed 1 mL. Participants will have a Tasso+™ device with Tasso+™ kits which 
either include SST or EDTA capillary collection tube, to be placed on each upper arm at 
each visit. Shaving of the upper arm area to remove excess body hair may be required. 
7.1.2 
Preparation, Handling, and Storage 
The Investigator (or designee) is responsible for the safe and proper storage of the 
medical device at the site. The medical device will be stored under controlled conditions 
according to the storage requirements described on the label(s), ie, 18 to 28ºC (64.4 to 
82.4ºF). Tasso+™ kits will be stored under controlled conditions according to the storage 
requirements described on the label(s), ie, 18 to 25°C (64.4 to 77ºF). The shelf lives of 
the Tasso+™ devices and Tasso+™ kits are of 12 months. The Investigator (or designee) 
will instruct the participants to store the medical device and kits in accordance with the 
instructions on the label(s). 
7.1.3 
Sterilization 
The Tasso+™ kits are sterile. The Tasso+™ device is rendered sterile by e-beam 
irradiation in accordance with ISO 11137-1, 11137-2, 11737-1, and 11737-2 Sterilization 
of Healthcare Products. The Tasso+™ device was validated for a minimum sterility 
assurance level of 10-6 following VDmax25 kGy test methods after being built per 
processes intended for the final configuration of the device. The Tasso+™ device 
sterilization process is controlled through internal work instructions and checklists. 
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7.1.4 
Packaging, Labelling, and Shipment 
The medical device will be packaged and labelled in accordance with all applicable 
regulatory requirements and Good Manufacturing Practice guidelines. 
The Tasso+™ is provided sterile and is packaged in an industry standard polymer tray 
and Tyvek cover as a primary sterile barrier. All system components are packaged in 
appropriately constrained packaging including corrugated boxes and labelling. 
Shipping is performed in accordance with Tasso SOP for the control and handling of 
product. Records are kept providing lot traceability for each site and each product. 
7.2 
Blinding 
This is an open-label study. Participants, HCPs, and laboratory technicians will not be 
blinded to the study intervention. 
7.3 
Method of Assigning Process 
Each participant will have a unique subject screening number obtained from the 
interactive voice response system (IVRS). Once the participant is deemed eligible, the 
participant will be assigned a randomization number. 
Randomization will be performed via a centralized IVRS. On Day 1, eligible participants 
will be assigned to either Cohort A or Cohort B in a 2:1 ratio. Each participant will 
receive a unique randomization number when he/she is assigned treatment. Participants 
will be allocated to treatment according to the randomization code. 
7.4 
Instruction for Use 
The section below provides an overview of the IFU. The detailed IFU will be provided in 
a separate document. Instructional video is available on Tasso Inc. website 
(http://www.tassoinc.com/tassoplus-video). The use of Tasso+™ kit is not intended for 
use in diagnostic procedures. 
The Tasso+™ kit includes the sterile, disposable Tasso+™ blood lancing device, and the 
supplies necessary to administer the device.  
When collecting a sample, the device will be held onto the skin by a mild adhesive. With 
a press of the button, a sterile lancet will puncture the skin, simultaneously creating a 
slight vacuum that will help capillary blood flow under gravity into a compatible tube. 
After a predefined time period, or when the tube is full, the device will be peeled off the 
skin. The tube will be removed and capped for shipment. The lancet is single use and 
automatically retracts into the device in a safe position after use. 
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Preparation steps notably include set-up of the participant, identification of the collection 
sites, insertion of applicable tube (SST or EDTA) into the device, and warming and 
cleaning of the collection site. 
Collection step notably includes sticking of the device to collection site, activation of the 
lancet, filling of the tube, removal of the device, closure of the tubes, and inversion of the 
tubes. 
Shipping and final steps notably include writing of participant’s ID number on tube, 
placing of tube in return bag, recording of the time and date of collection, packaging and 
shipping of tubes to the Central Laboratory, and discarding of leftover material 
(excepting Tasso+™). 
7.5 
Precautions and/or Lifestyle Considerations 
There are no lifestyle considerations (such as dietary or physical activity restrictions) for 
this study beyond those listed in the inclusion/exclusion criteria (Section 5). The 
Tasso+™ devices require a hair-free surface which may need the upper arm area to be 
shaved. 
Tasso+™ device and kits are not intended for more than one use. They should not be 
used on more than one participant. Improper use of blood lancets can increase the risk of 
inadvertent transmission of bloodborne pathogens, particularly in settings where multiple 
participants are being tested.  
For this Study, precautions for use are as follow:  
x For use only on a single participant. Discard the entire device after use.  
x Do not use after expiration date.  
x Single use only.  
x Keep out of reach of children.  
x Minor bruising or residual marks may occur at the sample collection site.  
x Do not resterilize.  
x For external use only.  
x Use while seated as fainting may occur with any blood sampling procedure.  
x Refer to manufacturer’s instructions for individual components.  
x Do not use if tray has been opened or damaged.  
7.6 
Prior Medication and Procedures 
Prior medication and procedures will be assessed at each visit as per Schedule of 
Assessment (Table 1). 
7.7 
Concomitant Medication and Procedures 
Concomitant medication and procedures will be assessed at each visit as per Schedule of 
Assessment (Table 1). 
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7.8 
Accountability 
The medical device must not be used for any purpose other than that defined in this 
protocol. All supplies of the medical device will be accounted for in accordance with 
Good Clinical Practice (GCP). 
The Investigator (or designee) will provide the medical device only to the identified 
participants in this study, according to the procedures described in this study protocol. 
After the end of the study, all unused medical devices should be destroyed at the clinical 
site or returned to the manufacturing company for destruction. In either instance, 
complete documentation will be returned to the manufacturing company. 
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8 ADVERSE EVENTS 
8.1 
Definitions 
8.1.1 
Adverse Events 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in clinical study participants, users 
or other persons, whether or not related to the investigational medical device and whether 
anticipated or unanticipated. An AE therefore includes events related to the 
investigational medical device and procedures involved. 
8.1.2 
Adverse Device Effects 
An adverse device effect (ADE) is any AE related to the use of an investigational medical 
device. ADE includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. ADE also includes events resulting from user error (see 
Section 8.1.8) or intentional misuse of investigational medical device. 
8.1.3 
Serious Adverse Events 
An SAE is any event that meets any of the following criteria: 
x Results in death. 
x Severe deterioration in the health of the participant by one or more of the following: 
(i) a life-threatening illness or injury; (ii) a permanent impairment of a body structure 
or function including chronic diseases; (iii) in-patient or prolonged hospitalization; 
(iv) medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or function; (v) fetal distress, fetal death, 
congenital abnormality or birth defect including physical or mental impairment. 
x 
The event will be considered an SAE when, based upon appropriate medical and 
scientific judgment, the event may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed above. SAEs include all 
serious events independent of whether they have a suspected causal relationship to the 
device or not. 
8.1.3.1 
Life-Threatening AE 
An AE is life-threatening if the participant was at immediate risk of death from the event 
as it occurred; ie, it does not include a reaction that, if it had occurred in a more severe 
form, might have caused death. It does not include an AE or suspected ADE that, had it 
occurred in a more severe form, might have caused death. 
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8.1.3.2 
AE Requiring Hospitalization 
AEs requiring hospitalization should be considered SAEs. Hospitalization for elective 
surgery, or for procedures planned prior to the participant providing informed consent, or 
routine clinical procedures that are not the result of an AE (eg, elective surgery for a 
pre‑existing condition that has not worsened) need not be considered AEs or SAEs. If 
anything untoward is reported during the procedure, that occurrence must be reported as 
an AE, either 'serious' or 'nonserious' according to the usual criteria. 
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. When in doubt as to whether hospitalization occurred or was 
necessary, the AE should be considered serious. 
8.1.3.3 
Disability/Incapacity 
An AE/ADE is incapacitating or disabling if the experience results in a substantial and/or 
permanent disruption of the participant’s ability to carry out normal life functions. 
8.1.4 
Serious Adverse Device Effects 
A serious adverse device effect (SADE) is defined as any ADE that has resulted in any of 
the consequences characteristic of an SAE (see Section 8.1.3). 
8.1.5 
Unanticipated Serious Adverse Device Effects 
An unanticipated serious adverse device effect (USADE) is defined as any SADE which 
by its nature, incidence, severity, or outcome has not been identified in the current risk 
assessment. 
8.1.6 
Device Deficiencies 
Device deficiency is defined as inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance. Device deficiencies 
include malfunctions (see Section 8.1.7), use errors (see Section 8.1.8), and inadequate 
labelling. 
Device deficiencies that did not lead to an AE but could have led to an SADE if (i) either 
suitable action had not been taken, (ii) intervention had not been made, or (iii) 
circumstances had been less fortunate; shall be reported to the Sponsor, the IRB/IEC, and 
the regulatory authorities. 
Device incidents/deficiencies will be reported by clinical sites by completing a device 
incident/deficiency form and providing it to the CRO’s safety team. 
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8.1.7 
Malfunctions 
Failure of an investigational medical device to perform in accordance with its intended 
purpose when used in accordance with the IFU or protocol, or investigator brochure (IB). 
8.1.8 
User Errors 
User error is defined as any action or any lack of action that results in a different medical 
device response than intended by the manufacturer or expected by the user. User error 
includes slips, lapses and mistakes. An unexpected physiological response of the 
participant does not itself constitute a user error. 
8.2 
Assessment of Adverse Events 
8.2.1 
Severity 
AE/ADE severity will be graded according to the following definitions: 
x Mild (Grade 1): events require minimal or no treatment and do not interfere with the 
participant’s daily activities 
x Moderate (Grade 2): events result in a low level of inconvenience. Moderate events 
may cause some interference with functioning 
x Severe (Grade 3): events interrupt a participant’s usual daily activity and may require 
systemic drug therapy or other treatment. Severe events are usually incapacitating 
x Life-threatening (Grade 4): events have life-threatening consequences; urgent 
intervention indicated 
8.2.2 
Causality 
Investigators are required to systematically assess the causal relationship between the 
AEs/SAEs and the exposure to the device. 
8.2.3 
Expectedness 
An unexpected (or unanticipated) event is defined as any event which by its nature, 
incidence, severity, or outcome has not been identified in the current risk assessment. 
8.3 
Documenting and Reporting Adverse Events 
Reporting of AEs will begin when the participant has provided informed consent and will 
continue up to the end of study Visit. All AEs will be monitored and recorded in the 
eCRF throughout the described reporting period. 
Occurrence of AEs may be volunteered spontaneously by the participant; discovered as a 
result of general, nonleading verbal questioning by the study staff; or determined by 
physical examination or other safety assessments. 
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For all AEs, the Investigator must pursue and obtain adequate information (a description 
of the event, severity, date of occurrence, duration, and any action, eg, 
treatment/follow‑up tests). The outcome of the event should be provided along with the 
Investigator’s assessment of the relationship to the device. The Investigator must also 
assess whether the event meets the criteria for classification as an SAE. 
It is the Investigator’s responsibility to review all documentation (eg, hospital notes, 
laboratory reports, and diagnostic reports) related to an AE. Wherever possible, the 
Investigator’s diagnosis, not the individual signs and symptoms, will be documented as 
the AE. 
Investigators are not obligated to actively seek AEs or SAEs after the participant’s 
conclusion of study participation. However, if the Investigator learns of any SAE, 
including death, at any time after a participant has been discharged from the study, and 
he/she considers the event to be reasonably related to the device or study participation, 
the Investigator must promptly notify the Sponsor. 
Participants will be provided with a Symptom questionnaire (available in eDiary) for 
recording unsolicited AEs and any concomitant medications used during the study. The 
participants will be given access to the eDiary on Day 1 and will be asked to record 
information in the eDiary for the duration of their participation in the study (daily 
notifications will be sent to the participant). The diaries will not be considered as source 
documents. Diary data will be transcribed by site personnel to source documents and then 
from that document, they will be entered into the EDC database and reviewed by the 
study monitor. 
For Grade 3 or Grade 4 AE considered related to device, and AE considered related to 
device leading to study discontinuation, the Investigator must immediately (no later than 
24 hours after becoming aware of the event) inform the Sponsor (or designee) of the AE 
utilizing the safety report form. 
8.4 
Reporting of Serious Adverse Events 
For SAEs with an onset inside the reporting period, SAEs considered related to device 
that occur after this reporting period, and device deficiencies that did not lead to an AE 
but could have led to an SADE, the Investigator must immediately (no later than 24 hours 
after becoming aware of the event) inform the Sponsor (or designee) of the SAE utilizing 
the safety report form (refer to the SAE contact information at the beginning of this 
protocol). 
The Investigator is obliged to respond to any request for follow-up information (eg, 
additional information, event outcome, final evaluation, or other records where needed) 
or to any question the Sponsor (or designee) may have concerning the SAE within the 
same timelines as those noted above for initial reports. This is necessary to ensure prompt 
assessment of the event by the Sponsor (or designee) and, as applicable, to allow the 
Sponsor to meet strict regulatory timelines associated with expedited reporting 
obligations for events of this nature. 
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8.5 
Adverse Event and Serious Adverse Event Follow-Up 
During the study (and after the end of study Visit), all AEs and SAEs should be followed 
proactively by the Investigator until the event resolves or the condition stabilizes to a 
level acceptable to the Investigator, until the event is otherwise explained, or until the 
participant is lost to follow-up. At the time the study participation ends, all ongoing AEs 
and SAEs should be evaluated for resolution. New or updated information will be 
recorded in the originally completed eCRF and the Investigator will submit any updated 
SAE information to the Sponsor within 24 hours of receipt of the information. 
8.6 
Safety Reporting Oversight 
In accordance with International Council for Harmonisation guidelines on Good Clinical 
Practice (ICH GCP), the Sponsor (or designee) will inform Investigators of “findings that 
could affect adversely the safety of participants, impact the conduct of the trial, or alter 
the IEC/IRB’s approval/favorable opinion to continue the trial.” 
The Sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a medical device under clinical 
investigation. The Sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, IRB/IEC, and Investigators. To 
support compliance with these requirements, the Investigator must provide requested 
information in a timely manner. 
An Investigator who receives an Investigator safety report describing SAEs or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will file it 
along with the IB and will notify the IRB/IEC, if appropriate, according to local 
requirements. 
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9  STATISTICS 
9.1 
General Procedures 
All personnel involved with the analysis of the study will be unblinded. Analyses will be 
performed using SAS 9.4 ® (or higher). 
The statistical analysis plan (SAP) will be approved prior to the first participant being 
enrolled. The SAP will provide a detailed description of the statistical methods and 
expand on the details provided in the protocol. 
Descriptive statistics (number of observations, mean, SD, median, minimum, and 
maximum) will be provided for continuous variables, and counts and percentages will be 
presented for categorical variables. 
9.2 
Analysis Sets 
The enrolled analysis set will include all participants who provide informed consent. This 
analysis set will be used to report disposition and screening failures. 
The full analysis set (FAS) will include all participants who administered Tasso+™ either 
in a site-supervised, proctor-supported, or unsupported setting. This analysis set will be 
the primary set used for analyses/summaries of the primary endpoint, as well as for 
secondary endpoint of seroconversion. 
The per protocol analysis set (PPS) will include all participants in the FAS and who 
successfully completed all administrations of Tasso+™. This analysis set will be used for 
sensitivity analyses. 
The safety analysis set (SAS) will include all participants who administered the medical 
device either in a site-supervised, proctor-supported, or unsupported setting. This analysis 
set will be used for summaries of safety data. 
9.3 
Sample Size 
Sample size was not calculated on a formal statistical basis; however, Sponsor estimates 
that the sample size will be sufficient to sample the diversity of user experience regarding 
the unsupported use of Tasso+™ for capillary blood collection. 
Each participant will be randomized to either Cohort A or Cohort B in a 2:1 ratio. Thus, it 
is planned to randomize approximately 133 participants into Cohort A and approximately 
67 participants into Cohort B. 
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9.4 
Statistical Methods 
9.4.1 
Primary Endpoints 
9.4.1.1 
Sample Integrity 
Descriptive statistics will be presented for the FAS and PPS to summarize the proportion 
of Tasso+™/SST and Tasso+™/EDTA samples collected on Day 1 for each cohort and 
on each of Days 29 and 57 for Cohorts A and B combined with the following attributes: 
x Adequate volume, defined as 300 μL (desired volume defined as 600 μL) 
x Without moderate or gross hemolysis, as defined by Central Laboratory SOP (see 
Table 5 in Section 6.3.1) 
x Without clotting, as assessed by the Central Laboratory 
9.4.1.2 
Testing Accuracy 
Pearson’s correlation coefficient will be computed to quantify the strength of the 
direction of the linear relationship between the venipuncture collection and the Tasso+™ 
collection at Day 1 for each cohort for SARS-CoV-2 serology and each chemistry 
analyte. This analysis will be presented for both the FAS and PPS. 
9.4.1.3 
Reliability 
x 
For each participant, the number of failures will be calculated by summing the 
instances where the device or the collection process has failed as follows: 
(i) 
failure in activation of the lancet 
(ii) lack of any blood collection within 5 minutes 
(iii) incorrect attachment of the capillary collection tube to the device 
(iv) damage to the device or the capillary collection tube upon handling 
(v) lack of maintained seal between the device and the skin surface of the participant 
(vi) incomplete trigger of the button (not fully pressing the button once the Tasso+™ 
device is sealed to the skin surface) 
x The total number of device usage instances will also be recorded. 
x 
The percentage of failures will be calculated as: 
x 
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x 
Counts and percentages will be presented for participants in the FAS and PPS. 
9.4.2 
Secondary Endpoints 
9.4.2.1 
Safety 
Counts and percentages will be presented for participants in the FAS who experience: 
x Solicited local AEs (including pain, tenderness, redness, swelling, or bruising) 
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x Unsolicited AEs 
x A related Grade 3 AE 
x A related Grade 4 AE 
x A related AE leading to discontinuation 
x A related SAE 
9.4.2.2 
Tolerability 
The counts and percentages of participants in the FAS who complete the Day 57 Visit 
will be summarized. 
9.4.2.3 
Usability 
Descriptive statistics will be presented for participants in the FAS for each aspect of the 
usability questionnaire on Days 1, 29, 57, and 85. 
9.4.2.4 
SARS‑CoV‑2 Infection Surveillance 
Counts and percentages will be presented for participants in the FAS for: 
x Participants with a positive nasopharyngeal swab for SARS-CoV-2 PCR on Day 1 
x Participants seroconverting to SARS-CoV-2 between Days 1 and 57 
9.4.3 
Exploratory Endpoint 
Descriptive statistics will be presented for participants who requested proctor support on 
Day 57 Visit and for participants who completed the Day 57 Visit without using the 
proctor support, for the following primary and secondary endpoints: 
x Sample integrity 
x Reliability 
x Safety 
x Usability 
9.4.4 
Analysis of Safety 
The SAS will be used for the analysis of safety data. 
AEs will be coded with MedDRA. AEs are defined as events with an onset date on or 
after the date of first administration of the medical device and before the date of last 
administration of the medical device (Visit 3, Day 57±3) +28 days, which corresponds to 
the Visit 4 (Day 85±3). TEAEs will be presented by system organ class and preferred 
term in frequency tables. Participants with multiple AEs will be counted only once within 
each preferred term and system organ class. 
Laboratory data (sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, 
phosphate, uric acid, and C-reactive protein) will be converted to Système International 
units for reporting and processing purposes. Absolute values will be presented 
descriptively. Laboratory data outside study-specific reference ranges will be listed. 
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9.4.5 
Demographic and Baseline Characteristics 
Demographic characteristics (including age, sex, ethnicity, and race) and baseline 
characteristics (including height, weight, BMI, supine systolic and diastolic blood 
pressure, pulse, body temperature, and respiratory rate) will be presented descriptively. 
Prior and concomitant medications will be listed. 
Past medical history will be listed. 
9.4.6 
Subgroup Analyses 
There are no subgroups within this study. 
9.4.7 
Handling of Missing Values 
Missing data will not be imputed. 
9.5 
Interim Analysis 
There is no interim analysis for this study. 
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10 RECORDS MANAGEMENT 
All clinical study information should be recorded, handled, and stored in a way that 
allows its accurate reporting, interpretation, and verification. This principle applies to all 
records referenced in this protocol, irrespective of the type of media used. 
10.1 
Source Documentation 
Source documents contain the results of original observations and activities of a clinical 
investigation. They are the original records in which raw data are first recorded. Source 
documents include, but are not limited to, medical records (progress notes), ECG and 
computer printouts, screening logs, completed scales, quality of life questionnaires, and 
recorded data from automated instruments. 
The Investigator/site personnel should maintain adequate and accurate source documents 
and study records that include all pertinent observations on each of the site’s study 
participants. Source data should be attributable, legible, contemporaneous, original, 
accurate, and complete. Changes to source data should be traceable, should not obscure 
the original entry, and should be explained if necessary (eg, via an audit trail). 
All source documents from this study are to be maintained by the Investigator and made 
available for inspection by authorized persons. The Investigator will provide direct access 
to source documents/data for study-related monitoring, audits, IRB/IEC review, and 
regulatory inspections. The Sponsor should verify that each participant has consented to 
direct access to his/her original medical records (progress notes) for study-related 
monitoring, audits, IRB/IEC review, and regulatory inspections. 
10.2 
Case Report Form Completion and Data Management 
An eCRF will be used to store and transmit participant information. The file structure and 
format for the eCRF will be provided by the Sponsor or its representative and should be 
handled in accordance with the instructions provided. 
The eCRF must be reviewed and electronically signed and dated by the Investigator. The 
Investigator is responsible for verifying that the data entries are accurate and correct by 
signing the eCRF. 
Access to the eCRF will be strictly password protected and limited to personnel directly 
participating in the study. Data should be entered into the eCRF completely by authorized 
site personnel (eg, Investigators and the study coordinator). The eCRF must be completed 
as soon as possible after any participant evaluation or communication. If data are to be 
changed due to erroneous input or other reason, an electronic audit trail will track the 
changes. The eCRF and computers that store them must be accessible to study monitors 
and other regulatory auditors. Changes to the eCRF will be electronically tracked. 
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Data will be entered/loaded into a validated electronic database using a clinical data 
management system. Computerized data cleaning checks will be used in addition to 
manual review to check for discrepancies and to ensure consistency of the data. 
During each study visit, a physician participating in the study will maintain progress 
notes in the participant’s medical records to document all significant observations. At a 
minimum, these notes are to contain: 
x The date of the visit and the corresponding day or visit in the study schedule 
x General condition and status remarks by the participant, including any significant 
medical findings. The severity, frequency, duration, and resolution of any reported 
AE, and the Investigator’s assessment as to whether or not the reported AE is related 
to the device 
x Changes (including dosages) in concomitant medications/therapies (including 
medical foods) or procedures 
x A general reference to the procedures completed 
x The signature or initials of all physicians making an entry in the medical record 
(progress notes) 
In addition, any contact with the participant via telephone or other means that provides 
significant clinical information is to also be documented in the medical record (progress 
notes), as described above. 
Information from the medical records (progress notes) and other source documents is to 
be promptly entered into the appropriate section of the eCRF. 
Changes to information in the medical record (progress notes) and other source 
documents are to be initialed and dated on the day the change is made by the Investigator 
(or designee). If the reason for the change is not apparent, a brief explanation for the 
change is to be written adjacent to the change. Changes to the eCRF will be electronically 
tracked. 
The ICON data management department will write a data management plan, which will 
be finalized prior to performing any data validation. 
10.3 
Study Files and Record Retention 
All data derived from the study will remain the property of the Sponsor. The Sponsor 
assumes accountability for actions delegated to other individuals, eg, the CRO. 
Records must be retained in accordance with the current ICH GCP Guidelines. All 
essential study documents, including records of participants, source documents, eCRFs, 
and the medical device inventory, must be kept on file. 
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Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region, or until at least 2 years have elapsed since the 
formal discontinuation of the clinical development of Tasso+™. However, essential 
documents may be retained for a longer period if required by the applicable regulatory 
requirements or by agreement with the Sponsor. The Sponsor is responsible for informing 
the Investigator when these documents need no longer be retained. 
The Investigator is not to dispose of any records relevant to this study without written 
permission from the Sponsor and is to provide the Sponsor the opportunity to collect such 
records. The Investigator shall take responsibility for maintaining adequate and accurate 
hard copy source documents of all observations and data generated during this study. 
Such documentation is subject to inspection by the Sponsor, its representatives, and 
regulatory authorities. 
If an Investigator moves, withdraws from a study, or retires, the responsibility for 
maintaining the records may be transferred to another person who will accept 
responsibility. Notice of transfer must be made to and agreed by the Sponsor. 
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11 ETHICS AND RESPONSIBILITIES 
11.1 
Good Clinical Practice 
This study will be conducted in accordance with the Note for Guidance on ICH GCP 
Harmonised Tripartite Guideline E6 (R1)/Integrated Addendum E6 (R2); US FDA CFR 
(Title 21 Parts 50, 56, 312); the general guidelines indicated in the Declaration of 
Helsinki; and all applicable regulatory requirements. 
11.2 
Institutional Review Board/Independent Ethics Committee 
Before initiating a study, the Investigator/institution must have written and dated 
approval/favorable opinion from the IRBs/IECs for the study protocol/amendment(s), 
eConsent form, any eConsent form updates, participant recruitment procedures (eg, 
advertisements), any written information to be provided to participants, and a statement 
from the IRBs/IECs that such written information comply with GCP requirements (if 
applicable). A current copy of the IB should be included as part of the written application 
to the IRBs/IECs. 
The IRB/IEC approval(s) must identify the protocol version as well as the documents 
reviewed. Any amendments to the protocol will require IRB/IEC approval before the 
implementation of the changes made to the study, except for changes necessary to 
eliminate an immediate hazard to the study participants. 
The Investigator will be responsible for the following: 
x Providing written summaries of the status of the study to the IRBs/IECs annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRBs/IECs 
x Notifying the IRBs/IECs of SAEs or other significant safety findings, including 
ADEs that are both serious and unexpected, as required by IRB/IEC procedures 
x Providing oversight of the conduct of the study at the site and adherence to the 
requirements of all applicable regulations 
x Reporting requests for deviations and reports of deviations if the deviation affects 
participant’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation 
x 
Deviations from the protocol to protect the rights, safety and well-being of study 
participant or to eliminate immediate hazards to study participant, under emergency 
circumstance, may proceed without prior approval of the Sponsor and the IRB/IEC. In 
such a case, the Investigator will be responsible for promptly documenting and reporting 
deviations. 
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11.3 
Informed Consent 
In obtaining and documenting informed consent, the Investigator should comply with the 
applicable regulatory requirement(s) and should adhere to GCP and to the ethical 
principles that have their origin in the Declaration of Helsinki. Prior to the beginning of 
the study, the Investigator must have the written and dated approval/favorable opinion 
from the IRBs/IECs of the eConsent form (including updates) and any other written 
information to be provided to participants. 
x The Investigator or his/her representative will explain the purpose and nature of the 
study as well as possible benefits, risks, and adverse effects to the participant or 
his/her legally acceptable representative and answer all questions regarding the study. 
x Participants must be informed that their participation is voluntary, and consent can be 
withdrawn at any point. Participants should be informed of possible treatment 
alternatives, including the follow-up measures if their participation in the study is 
discontinued. 
x Participants or their legally acceptable representative will be required to electronically 
sign a statement of informed consent that meets the requirements of US FDA CFR 
Title 21 Part 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act requirements in the US, and the IRB/IEC or clinical site. 
x Prior to a participant’s enrollment in the study, the eConsent form should be signed 
and personally dated by the participant or by the participant’s legally acceptable 
representative, and by the person who conducted the informed consent discussion.  
x The medical record must include a statement that informed consent was obtained 
before the participant was enrolled in the study and the date the consent was obtained. 
x A copy of the eConsent form and any other information must be provided to the 
participant or the participant’s legally acceptable representative. 
x If the eConsent form is revised, the revised form must have received the IRB/IEC’s 
approval/favorable opinion in advance of its use. Participants must be informed of the 
changes to the eConsent form and must reconsent to the most current version during 
their participation in the study. The participant or the participant’s legally acceptable 
representative should be informed in a timely manner if new information becomes 
available that may be relevant to the participant’s willingness to continue 
participation in the study. The communication of this information should be 
documented. 
Participants who are rescreened are required to electronically sign a new eConsent form. 
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11.4 
Recruitment Strategy 
Potential participants at the clinical sites will be identified and approached for 
recruitment as described in Section 6.1.1. 
11.5 
Data Monitoring Committee 
Given that the Tasso+™ device is an FDA cleared device and has been deemed to be 
associated with minimal risk, there are no plans to convene a data monitoring committee 
for this study. 
11.6 
Financing and Insurance 
11.6.1 
Contractual and Financial Details 
The Investigator (and/or, as appropriate, the hospital administrative representative) and 
the CRO will sign a clinical study agreement prior to the start of the study, outlining 
overall responsibilities in relation to the study. The Sponsor will review the clinical study 
agreement. The contract should describe whether costs for pharmacy, laboratory, and 
other protocol-required services are being paid directly or indirectly. 
11.6.2 
Insurance, Indemnity, and Compensation 
Participants will receive compensation for each study visit. Specifics of compensation are 
described in the eConsent form and approved by the IRB. 
11.6.3 
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. 
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12 AUDITING AND MONITORING 
The study may be prematurely terminated at the discretion of JPEO and PI. The 
Investigator may terminate the study due to concerns of participant safety. The study will 
be made available for monitoring, auditing, IRB review, and regulatory inspection by 
providing direct access to study-related source data. 
12.1 
Monitoring 
Sponsor-assigned monitors will conduct regular site visits to the investigational facilities 
for the purpose of monitoring various aspects of the study, such as assessing participant 
enrollment, compliance with protocol procedures, completeness and accuracy of data 
entered into the eCRFs, verification of eCRF data against original source documents, and 
occurrence of AEs. The Investigator must agree to Sponsor-authorized personnel having 
direct access to the clinical (or associated) files and clinical study supplies (dispensing 
and storage areas) to ensure compliance with applicable regulations, and the Investigator 
will assist with the Sponsor’s monitoring activities. 
The objectives of a monitoring visit will be: 
x To verify the existence of electronically signed informed consent documents and 
documentation of the informed consent process for each enrolled participant; 
x To verify the prompt and accurate recording of all monitored data points and 
prompt reporting of all SAEs; 
x To help ensure Investigators are in compliance with the protocol. The monitors 
also will inspect the clinical site regulatory files to ensure that regulatory 
requirements (Office for Human Research Protections), FDA, and applicable 
guidelines (ICH GCP) are being followed. During the monitoring visits, the 
Investigator (and/or designee) and other study personnel will be available to 
discuss the study progress and findings of the monitoring visit. 
A specific study monitoring plan will be discussed with the PI and study staff prior to 
enrollment. The plan will outline the frequency of monitoring visits based on such factors 
as study enrollment, data collection status, and regulatory obligations. Protocol deviation 
reporting will be outlined in a study monitoring plan. 
Quality control will occur at each stage of data handling to ensure that all data are reliable 
and have been processed correctly. The Sponsor should ensure oversight of any 
study-related duties and functions carried out on its behalf, including those that are 
subcontracted to another party by the Sponsor’s contracted CRO(s). 
The eCRFs should be completed in a timely manner and on an ongoing basis to allow 
regular review by the study monitor. 
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The Investigator (or designee) may interrupt the collection of samples or discontinue the 
participant from the study, if indicated, for unanticipated problems or AEs. In addition, 
the Investigators are responsible for: 
x Protecting the safety and welfare of participants 
x Evaluating participant safety, including physician assessment of AEs for 
seriousness, severity, and causality 
x Notifying the Sponsor of SAEs and immediately reportable events 
x Providing detailed written reports, including confirmatory tests promptly 
following immediate initial reports 
x Informing the IRB of SAEs 
Details describing the strategy, responsibilities, and requirements of the study monitoring 
are provided in the study monitoring plan. 
12.2 
Audits and Inspections 
The purpose of an audit is to assess whether ethics, regulatory, and quality requirements 
are being fulfilled. The Sponsor or its representative may conduct audits at the 
investigative sites including, but not limited to, supply, presence of required documents, 
the informed consent process, and comparison of eCRFs with source documents. 
Government regulatory authorities may also inspect the Investigator during or after the 
study. The Investigator (or designee) should contact the Sponsor/CRO immediately if this 
occurs. All medical records (progress notes) must be available for audit. The Investigator 
must agree to participate with audits conducted at a convenient time in a reasonable 
manner. 
12.3 
Risk and Quality Tolerance Limits 
Perceived risks and quality tolerance limits (QTLs) will be identified and documented 
before the start of the study. 
The Sponsor will review risk control measures periodically to ascertain whether the 
implemented quality management activities remain effective and relevant. The quality 
management approach and any important deviations from the predefined QTLs (and 
remedial actions adopted) will be described in the clinical study report (CSR). 
12.4 
Protocol Adherence and Deviations 
The Investigator and site personnel should conduct the study in compliance with the 
protocol and should use continuous vigilance to identify and report protocol deviations. 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol that may be on the part of the Investigator, site 
personnel, or the participant. 
Important protocol deviations are a subset of protocol deviations that may significantly 
impact the completeness, accuracy, and/or reliability of the study data, or that may 
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significantly affect a participant’s rights, safety, or well-being. For example, important 
protocol deviations may include enrolling participants in violation of key eligibility 
criteria designed to ensure a specific population, or failing to collect data necessary to 
interpret primary endpoints, as this may compromise the scientific value of the study. 
The Investigator should not implement any deviation from the protocol without 
agreement from the Sponsor and prior review and approval of an amendment from the 
IRB/IEC, except where necessary to eliminate an immediate hazard to a study participant, 
or when the change involves only logistical or administrative aspects of the study, such as 
a change in a monitor or telephone number. 
In the event of an important protocol deviation, the Investigator will discuss the deviation 
with the Sponsor’s medical monitor and will come to an agreement as to whether the 
participant should be withdrawn from the study due to the important protocol deviation. 
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13 AMENDMENTS 
Protocol modifications, except those intended to reduce immediate risk to study 
participants, may be made only by the Sponsor. A protocol change intended to eliminate 
an apparent immediate hazard to participants should be implemented immediately. 
Any permanent change to the protocol must be handled as a protocol amendment. The 
written amendment must be submitted to the IRB/IEC, and the Investigator must await 
approval before implementing the changes. The Sponsor will submit protocol 
amendments to the appropriate regulatory authorities for approval. 
The current version of the eConsent form will require similar modification if the 
IRB/IEC, Investigator, and/or Sponsor judge the amendment to the protocol to 
substantially change the study design and/or increase the potential risk to the participant 
and/or impact the participant’s involvement in the study. In such cases, the eConsent 
form will be renewed for enrolled participants before their continued participation in the 
study. 
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14 STUDY REPORT AND PUBLICATIONS 
This study will be registered on ClinicalTrials.gov in accordance with applicable laws or 
publication policy and may also be registered on other publicly accessible websites as 
necessary. 
The Sponsor is responsible for preparing and providing the appropriate regulatory 
authorities with the CSR according to the applicable regulatory requirements. The 
Sponsor should ensure that the CSR meets the standards of the ICH Guideline for 
Structure and Content of Clinical Study Reports (ICH E3). 
The publication policy of the Sponsor is discussed in the Investigator’s clinical research 
agreement. 
The results of this study may be published or presented at scientific meetings. If this is 
foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor 
before submission. This allows the Sponsor to protect proprietary information and to 
provide comments. 
The Sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the Sponsor will generally 
support publication of multicenter studies only in their entirety and not as individual site 
data.  
Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 
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15 STUDY START AND TERMINATION 
The study start date is the date on which the first participant provides informed consent. 
The end of the study is defined as the last participant’s last assessment. 
The study may be prematurely terminated at the discretion of JPEO and PI. The 
Investigator may terminate the study due to concerns of participant safety. Both the 
Sponsor and the Investigator reserve the right to terminate the study or the participation 
in the study at an Investigator’s site at any time. In terminating the study, the Sponsor and 
the Investigator will assure that adequate consideration is given to the protection of the 
participants’ interests. 
If the study is prematurely terminated or suspended for any reason, the 
Sponsor/Investigator/site personnel should promptly inform the study participants and 
should assure appropriate therapy and follow-up for the participants. Where required by 
the applicable regulatory requirements, the IRB/IEC should be informed promptly and be 
provided with a detailed written explanation of the termination or suspension. 
If the Investigator terminates or suspends a study without prior agreement of the Sponsor, 
the Investigator should inform the site personnel. The Investigator/site personnel should 
promptly inform the Sponsor and the IRB/IEC. The Investigator/site personnel should 
also provide the Sponsor and the IRB/IEC a detailed written explanation of the 
termination or suspension. 
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16 CONFIDENTIALITY 
All information generated in this study is considered highly confidential and must not be 
disclosed to any person or entity that is not directly involved with the study unless prior 
consent is gained from the Sponsor. However, authorized regulatory officials, IRB/IEC 
personnel, the Sponsor, and its authorized representatives are allowed full access to the 
records. 
All study participants must be informed that their 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 eConsent form. The participants must be informed that their 
medical records (progress notes) may be examined by auditors or other authorized 
personnel appointed by the Sponsor, by appropriate IRB/IEC personnel, and by 
inspectors from regulatory authorities. 
Identification of participants and eCRFs shall be by unique identification numbers (such 
as screening number) only. All personal identifiers according to applicable regulations 
(eg, name, phone number) must be redacted permanently by the site personnel and 
replaced with the participant’s unique identification number in all records and data before 
transfer to the Sponsor (or designee). 
All personal details will be treated as confidential by the Investigator and staff at ICON. 
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17 REFERENCES 
Brandsma J, Chenoweth JG, Gregory MK, et al. Assessing the use of a micro-sampling 
device for measuring blood protein levels in healthy subjects and COVID-19 patients. 
pLoS One. 2022;17(8):e0272572. 
CDC. Symptoms of COVID-19. Updated 26 October 2022 
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html  
FDA. FDA Guidance on Conduct of Clinical Trials of Medical Products During the 
COVID-19 Public Health Emergency. August 2021. FDA-2020-D-1106-0002 
FDA. Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Draft 
Guidance. May 2023. FDA-2022-D-2870 
Fedoruk MN. Virtual drug testing: redefining sample collection in a global pandemic. 
Bioanalysis. 2020;12(11):715-718. 
Hendelman T, Chaudhary A, LeClair AC, et al. Self-collection of capillary blood using 
Tasso-SST devices for Anti-SARS-CoV-2 IgG antibody testing. PLoS One. 
2021;16(9):e0255841. 
JPEO-003, Summary of Results. 03 June 2022 
Tasso. Tasso+™ Investigator Brochure. PN0558-01, rev3. Effective Date: 12 Sep 2023 
van Loo IHM, Dukers-Muijrers NHTM, Heuts R, et al. Screening for HIV, hepatitis B 
and syphilis on dried blood spots: A promising method to better reach hidden high-risk 
populations with self-collected sampling. PLoS One. 2017;12(10):e0186722. 
Wixted D, Neighbors CE, Pieper CF, et al. Comparison of a Blood Self-Collection 
System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing. Diagnostics 
(Basel). 2022;12(8):1857. 
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18 APPENDICES 
18.1 
Appendix I – Study Administrative Structure 
Sponsor: 
Resilience Government Services, Inc.  
Jordan Bauers, PharmD 
13200 NW Nano Court, Alachua, FL 32615 
email: Jordan.Mitchell@resilience.com 
Fax: +1 888 551 1691 
Medical monitor: 
Robert Spitz, MD, Medical Director 
ICON plc 
CRO: 
ICON plc 
Corporate Headquarters 
South County Business Park 
Leopardstown, Dublin 18  
Ireland 
Phone (IRL): +353 1 291 2000 
Phone (US): +1 215 616 3000  
Fax: +353 1 247 6260 
Central laboratory: 
Brendan McLoughlin, Director, Laboratory Operations 
ICON plc 
A log of the name and title of the Investigators who are responsible for conducting the 
study, and the addresses and telephone numbers of the clinical sites will be maintained. 
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18.2
Appendix II – Non-Significant Risk Letter
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