SARS-CoV-2 Prevalence Study
Conditions: COVID-19
Sponsor: COVID-19 Prevention Network

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CoVPN 5002  
 
 
SARS-COV-2 PREVALENCE STUDY 
 
 
DAIDS-ES ID: 38749 
 
 
A Study by the COVID-19 Prevention Network (CoVPN) 
 
 
 
Sponsored by: 
United States (US) National Institute of Allergy and Infectious Diseases (NIAID) 
US National Institutes of Health (NIH) 
 
 
 
Non-IND Study 
 
 
Protocol Chair: 
Jessica Justman, MD 
 
Protocol Co-Chair: 
Christopher Amos, PhD 
 
 
 
Version 2.0 
26 May 2021 

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TABLE OF CONTENTS 
 
1.1 
Background and Rationale ................................................................................................ 11 
1.2 
Study Design ..................................................................................................................... 13 
2.1 
Primary Objective and Endpoint ....................................................................................... 14 
2.2 
Secondary Objectives and Endpoints ................................................................................ 14 
2.3 
Exploratory Objectives ..................................................................................................... 15 
3.1 
Inclusion Criteria .............................................................................................................. 16 
3.2 
Exclusion Criteria ............................................................................................................. 16 
3.3 
Recruitment Process ......................................................................................................... 16 
3.4 
Participant Retention ......................................................................................................... 17 
3.5 
Participant Withdrawal ..................................................................................................... 17 
3.6 
Community Definition ...................................................................................................... 18 
4.1 
Informed Consent ............................................................................................................. 18 
4.2 
Enrollment ........................................................................................................................ 19 
4.3 
Questionnaire Administration ........................................................................................... 19 
4.4 
Phlebotomy ....................................................................................................................... 19 
4.5 
Nasal Mid-Turbinate Swab Sample Collection ................................................................ 19 
4.6 
Saliva Substudy ................................................................................................................. 19 
4.7 
SARS-CoV-2 Counseling ................................................................................................. 20 
4.8 
SARS-CoV-2 Results Reporting....................................................................................... 20 
4.9 
Medical Records Abstraction for Senior Living Facility Participants .............................. 20 
6.1 
Review of Study Design ................................................................................................... 20 
6.2 
Sample Size....................................................................................................................... 21 
6.3 
Statistical Analyses ........................................................................................................... 22 
7.1 
Specimen Collection ......................................................................................................... 23 
7.2 
CRS Lab Procedures ......................................................................................................... 23 
7.3 
Endpoint Assays ............................................................................................................... 23 
7.4 
Exploratory Studies ........................................................................................................... 23 
7.5 
Specimen Storage and Other Use of Specimens ............................................................... 24 
7.6 
Biohazard Containment .................................................................................................... 24 
8.1 
Ethical Review .................................................................................................................. 24 
8.2 
Informed Consent ............................................................................................................. 25 
8.3 
Risks ................................................................................................................................. 26 
8.4 
Benefits ............................................................................................................................. 26 

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8.5 
Compensation ................................................................................................................... 26 
8.6 
Confidentiality .................................................................................................................. 26 
8.7 
Communicable Disease Reporting Requirements............................................................. 27 
8.8 
Study Discontinuation ....................................................................................................... 27 
9.1 
Protocol Registration ........................................................................................................ 27 
9.2 
Study Activation ............................................................................................................... 27 
9.3 
Study Coordination ........................................................................................................... 27 
9.4 
Study Monitoring .............................................................................................................. 28 
9.5 
Protocol Compliance ......................................................................................................... 28 
9.6 
Investigator’s Records ...................................................................................................... 29 
9.7 
Use of Information and Publications ................................................................................ 29 
9.8 
ClinicalTrials.gov ............................................................................................................. 29 
 
 
 

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PROTOCOL SIGNATURE PAGE 
 
 
DAIDS-ES ID # 38749 
 
Version 2.0 
26 May 2021 
 
 
 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable protocol-
related documents. I agree to conduct this study in compliance with United States (US) Health and 
Human Service regulations (45 CFR 46); applicable US Food and Drug Administration regulations; 
standards of the International Conference on Harmonization Guideline for Good Clinical Practice (E6); 
Institutional Review Board/Ethics Committee determinations; all applicable in-country, state, and local 
laws and regulations; and other applicable requirements (e.g., US National Institutes of Health, Division 
of AIDS) and institutional policies. 
 
I have read and understand the information in this protocol and will ensure that all associates, colleagues, 
and employees assisting in the conduct of the study are informed about the obligations incurred by their 
contribution to the study.  
 
 
____________________________________ 
Name of Investigator of Record (print name) 
  
 
 
____________________________________         
_______________________ 
Signature of Investigator of Record              
 
Date (DD/MONTH/YYYY) 
  

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SARS-COV-2 PREVALENCE STUDY 
 
LIST OF ABBREVIATIONS AND ACRONYMS 
 
Ab(s) 
 
Antibody/Antibodies 
ACTG  
AIDS Clinical Trials Group 
ADA 
 
Antidrug antibodies 
AE(s) 
 
Adverse Event(s) 
ARDS  
Acute Respiratory Distress Syndrome 
CDC 
 
(United States) Center for Disease Control and Prevention 
CFR 
 
Code of Federal Regulations 
COVID-19 
Coronavirus Disease 2019 
CoVPN  
COVID-19 Prevention Network 
CRMS  
(NIAID) Clinical Research Management System 
CRPMC  
(NIAID) Clinical Research Products Management Center 
CRF(s)  
Case Report Form(s) 
DAIDS  
Division of AIDS 
DHHS  
US Department of Health and Human Services 
EUA 
 
Emergency Use Authorization 
FDA 
 
(United States) Food and Drug Administration 
HPTN 
 
HIV Prevention Trials Network 
HVTN  
HIV Vaccine Trials Network 
ICF(s) 
 
Informed consent form(s) 
ICH 
 
International Council for Harmonisation 
IDCRC  
Infectious Diseases Clinical Research Consortium 
IMPAACT 
International Maternal Pediatric Adolescent AIDS Clinical Trials Group 
IoR 
 
Investigator of Record 
IRB(s)  
Institutional Review Board(s) 
LAR 
 
Legally Authorized Representative 
LC 
 
Laboratory Center 
LOC 
 
Leadership and Operations Center 
mAb(s)  
Monoclonal Antibody/Antibodies 
MOE 
 
margin of error 
NIAID  
(United States) National Institute of Allergy and Infectious Diseases 
NIH 
 
(United States) National Institutes of Health 
OHRP  
Office of Human Research Protections 
PP 
 
per-protocol 
PRO 
 
(DAIDS) Protocol Registration Office 
RSC 
 
(DAIDS) Regulatory Support Center 
SAE(s)  
Serious Adverse Event(s) 
SAP 
 
Statistical Analysis Plan 
SDMC  
Statistical and Data Management Center 
SARS 
 
Severe Acute Respiratory Syndrome 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
sIRB 
 
single IRB 
SOE 
 
Schedule of Events 
SSP 
 
Study-Specific Procedures manual 
TLS 
 
Time-location Sampling 
US 
 
United States 
 

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SARS-COV-2 PREVALENCE STUDY 
 
PROTOCOL TEAM ROSTER 
 
 
PROTOCOL CHAIR: 
Jessica Justman, MD 
ICAP at Columbia  
Mailman School of Public Health  
Departments of Epidemiology and Medicine 
Columbia University 
722 West 168th Street, NY NY 10032 
Phone: 212 342 0505 
Email: jj2158@cumc.columbia.edu 
 
PROTOCOL CO-CHAIR 
Christopher Amos, PhD 
Dan L Duncan Comprehensive Cancer Center 
Baylor College of Medicine 
1 Baylor Plaza 
Houston, TX 77030 
Email: chrisa@bcm.edu 
 
Ariane van der Straten, PhD, MPH 
HPTN Socio-Behavioral and Structural Working 
Group Liaison 
ASTRA Consulting 
Kensington, CA 94708 
phone: 510-374-9187 
email: arianevds@gmail.com  
 
Ayana Moore, PhD 
Associate Project Director, HPTN 
Leadership and Operations Center 
FHI 360 
359 Blackwell St. Suite 200 
Durham NC 27701 
Phone: 919-544-7040 ext. 11244 
Email: amoore@fhi360.org 
 
Daniel Szydlo, MSc  
Statistical Research Associate 
HPTN Statistics and Data Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave N  
Seattle, WA 98109  
Phone: 206-667-7451 
Email: dszydlo@scharp.org 
 
David Burns, MD, MPH 
Medical Officer 
NIAID/NIH 
5601 Fishers Lane, Room 8B40 
Rockville MD 20852, USA 
Phone: 301-435-8896 
Email: burnsda@niaid.nih.gov 
 
Deborah Donnell, PhD 
Biostatistician, HPTN Statistical and Data 
Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave. North, M2-C118  
PO Box 19024  
Seattle, WA 98109  
Phone: 206-667-5661  
Email: deborah@scharp.org 
 
Domonique Reed, MPH 
Research Assistant 
Mailman School of Public Health  
Department of Epidemiology  
Columbia University 
722 West 168th Street, NY NY 10032 
Email: dmr2204@cumc.columbia.edu 
 
Estelle M. Piwowar-Manning, BS, MT 
Deputy Director, HPTN Laboratory Center 
Johns Hopkins University  
Pathology Building, Room 313  
600 North Wolfe Street  
Baltimore, MD 21287 
Phone: 410-614-6736  
Email: epiwowa@jhmi.edu  
 

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Holly Janes, PhD 
Biostatistician, HVTN Statistical and Data 
Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave. North, M2-C200  
Seattle, WA 98109  
Phone: 206-667-6353 
Email: hjanes@fredhutch.org 
 
James Kublin, MD, MPH 
Executive Director, HVTN 
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave. North, E3-300 
Seattle, WA 98109  
Phone: 206-667-1970 
Email: jkublin@fredhutch.org 
 
Jeffrey Shaman, PhD 
Mathematical Modeler 
Mailman School of Public Health  
Department of Environmental Health Sciences 
Columbia University 
722 West 168th Street,  
New York , NY 10032 
Phone: 212-305-3590 
Email: jls106@cumc.columbia.edu 
 
Jonathan Lucas, MPH 
Community Program Manager 
HPTN Leadership and Operation Center 
FHI 360 
359 Blackwell Street Suite 200 
Durham, NC 27701 
Phone: 919-544-7040 ext. 11458 
Email: jlucas@fhi360.org  
 
Jontraye Davis, MHA, PMD Pro 
Community Program Manager 
HPTN Leadership and Operation Center 
FHI 360 
359 Blackwell Street Suite 200 
Durham, NC 27701 
Phone: 919-544-7040 ext. 11715 
Email: jodavis@fhi360.org 
 
Kathleen Neuzil, MD, MPH, FIDSA 
Co-Principal Investigators, IDCRC 
University of Maryland School of Medicine 
655 W. Baltimore Street 
Baltimore MD 21201 
Phone: 410-706-4946 
Email: kneuzil@som.umaryland.edu 
 
Krista Yuhas, MSc 
Statistical Research Associate 
HPTN Statistics and Data Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave N  
Seattle, WA 98109  
Phone: 205-667-7379 
Email: kyuhas@scharp.org 
 
Laura Mkumba, MScGH 
Prevention Research Specialist  
HPTN Leadership and Operations Center 
FHI 360 
359 Blackwell St. Suite 200 
Durham, NC 27701 
Phone: 919-544-7040 
Email: lmkumba@fhi360.org 
 
Leah Schrumpf, MSc 
Clinical Research Manager  
HPTN Leadership and Operations Center 
FHI 360 
359 Blackwell St. Suite 200 
Durham, NC 27701 
Phone: 919-544-7040 ext. 11909 
Email: lschrumpf@fhi360.org 
 
Lynda Emel, PhD 
Associate Director, HPTN Statistical and Data 
Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Avenue North M2-C118 
Seattle, WA 98109 
Phone: 206-667-5803 
Email: lemel@scharp.org 
 

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Maggie Brewinski Isaacs, MD, MPH, FAAP, 
FACPM 
Medical Officer 
NIH/NIAID/DAIDS/VRP/VCRB 
5601 Fishers Lane, 9C44, MSC 9829 
Rockville, MD 20852-9829 
Phone: 301-761-7009 
Email: Maggie.brewinskiisaacs@nih.gov 
 
Mark Marzinke, PhD  
Analytical Pharmacologist  
HPTN Laboratory Center  
Johns Hopkins University  
Department of Pathology  
1800 Orleans Street  
Sheikh Zayed Tower, Room B1-1020F  
Baltimore, MD 21287 USA 
Phone: 443-287-7516  
Email: mmarzin1@jhmi.edu  
 
Melissa M. Turner, MSW, LICSW, MPA 
HPTN Community Working Group Liaison 
Washington Veterans Affairs Medical Center 
50 Irving Street NW (151B) 
Washington, DC 20422 
Phone: 202-745-8695 
Email: melissa.turner@va.gov 
 
Nirupama Deshmane Sista, PhD 
Director, HPTN  
Leadership and Operations Center 
FHI 360 
359 Blackwell St. Suite 200 
Durham, NC 27701 
Phone: 202-884-8353 ext. 18941 
Email: nsista@fhi360.org 
 
Pamina M. Gorbach, MHS, DrPH  
Epidemiologist  
Division of Infectious Diseases, David Geffen 
School of Medicine 
University of California, Los Angeles  
CHS 41-295  
Los Angeles, CA 90095 
Phone: 310-794-2555  
Email: pgorbach@ucla.edu 
 
 
 
 
 
Sahar Zangeneh, PhD 
Protocol Statistician 
RTI International 
3040 East Cornwallis Road, P.O. Box 12194 
Research Triangle Park, NC, United States 
27709-2194 
Email: szangeneh@rti.org 
 
Shahnaz Ahmed 
QA/QC Coordinator HPTN Lab Center 
Johns Hopkins University 
600 Wolfe Street Pathology 311 
Baltimore, MD 21287 
Phone: 410-614-6737 
Email: sahmed60@jhmi.edu 
 
Sten Vermund, MD, PhD 
HPTN Executive Committee Liaison 
Yale School of Public Health 
PO Box 208034 
New Haven, CT 06510-3201 
Phone: 203-785-2867 
Email: sten.vermund@yale.edu 
 
Susan Eshleman, MD/PhD 
Virologist, HPTN Laboratory Center 
Johns Hopkins University School of 
Medicine 
720 Rutland Ave. 
Ross Building, Room 646 
Baltimore MD, 21205 
Phone: 410-614-4734 
Email: seshlem@jhmi.edu 
 
Timothy Skalland, PhD  
Protocol Statistician 
HPTN Statistics and Data Management Center  
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave N  
Seattle, WA 98109  
Phone: 206-667-1186  
Email: tskallan@fredhutch.org 
 
Wafaa El-Sadr, MD, MPH 
Co-Principal Investigator, HPTN 
ICAP at Columbia University 
Mailman School of Public Health 
722 West 168th Street, Room 1312 
New York, NY 10032 
Phone: (212) 342-0505 
Email: wme1@columbia.edu 

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SARS-COV-2 PREVALENCE STUDY 
 
SCHEMA 
 
Design: 
Cross-sectional surveys of (1) adults residing in senior living facilities and attending outpatient healthcare 
facilities, and (2) the general population in each selected research site community. 
 
Population: 
1) Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and 
attending outpatient healthcare facilities in neighborhoods of selected research sites 
2) Adults and children (> 2 months of age) in neighborhoods of selected research sites 
 
Study Size:  
For each research site, up to 3,920 individuals will be enrolled from one, two, or all three of the following 
populations (must include at least community venues):  
 
1) senior living facilities (nursing homes, assisted or independent living facilities; n = 500) 
2) outpatient healthcare facilities (n = 500) 
3) community venues distributed across four age categories (0-17, 18-39, 40-59, 60+ years) (n = 730 per 
stratum or 2920)  
 
Total sample size = 3,920 x up to 20 clinical research sites 
 
Study Duration: 
Approximately sixteen (16) months for overall project. Two (2) months for protocol development and 
institutional review board (IRB) approval, followed by:  
 
1) Facility-based surveys: 12 months (3 months for site preparation and initiation, 3 months for 
enrollment/sample collection, 4 months for shipping and laboratory testing*, 2 months for close-out), 
concurrent with  
2) Time-location sampling (TLS) surveys: 14 months (3 months for site preparation and initiation, 6 
months for enrollment/sample collection, 6 months for shipping and laboratory testing*, 2 months for 
close-out) 
 
*Some activities will be concurrent with enrollment 
 
Study Location: 
Catchment areas surrounding US-based Clinical Research Sites (CRSs) of the: HIV Prevention Trials Network 
(HPTN), HIV Vaccine Trials Network (HVTN), Infectious Diseases Clinical Research Consortium (IDCRC), 
International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), and the AIDS Clinical 
Trials Group (ACTG); to be specified in the Site Announcement Memo 
 
Study Methods: 
Blood collection for SARS-CoV-2 antibody testing and characterization of the serologic response to SARS-
CoV-2 infection; nasal mid-turbinate swab collection for SARS-CoV-2 RNA testing; collection of saliva in a 
subset of participants to evaluate the performance of diagnostic SARS-CoV-2 assays using these matrices; 
administration of tablet-based survey. Medical records abstraction for senior living facility participants who 
are unable to respond to the study survey. 

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Primary Objective: 
To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding 
selected NIAID clinical research sites 
Secondary Objectives: 
1) To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing 
2) To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent 
with COVID-19 
3) To estimate seroprevalence of SARS-CoV-2 among:  
a. Those without past or current symptoms consistent with COVID-19  
b. Those with no prior positive SARS-CoV-2 testing, but who report close contact with 
confirmed or presumed cases 
c. Those with history of co-morbid medical conditions  
4) To assess association between demographic, clinical and social factors with SARS-CoV-2 infection 
and seroprevalence  
5) To estimate potential size of populations for referral to COVID-19 prevention and treatment studies 
6) To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 
7) To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva 
samples  
Exploratory Objectives:  
1) To model epidemiologic impact over time of COVID-19 in the study communities, including modeled 
incidence and prevalence of COVID-19.  
 
2) To conduct laboratory testing in a subset of participants to characterize SARS-CoV-2 viruses and the 
host response to SARS-CoV-2 infection; this may include testing for SARS-CoV-2 IgM antibodies.  
This testing may also include phylogenetic analysis of SARS-CoV-2 and co-infections with other 
viruses, including viruses that impact the specificity of SARS-CoV-2 serologic assays. 
 
 
 

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INTRODUCTION 
 
1.1 
Background and Rationale 
 
Currently, the United States (US) has far more confirmed COVID-19 cases than any other country. 
The US epidemic is remarkably heterogeneous, with many cities and communities experiencing a 
disproportionately high disease burden and mortality. For example, at present, Minneapolis, Houston, 
Atlanta, and Durham NC, are projected to bear the brunt of the US epidemic and in the future, other 
communities may see an increase in the number of COVID-19 cases.  
 
There is an urgent need to address the COVID-19 pandemic in a multipronged, expeditious manner to 
identify effective interventions for COVID-19 treatment and prevention. The National Institute of 
Allergy and Infectious Diseases (NIAID) has therefore mobilized its major research networks under 
the banner of the COVID-19 Prevention Network (CoVPN) to work together in the rapid evaluation of 
COVID-19 treatment and prevention strategies. This approach leverages the well-established 
infrastructure, expertise, and on-going partnership of these networks with the resources of the NIH and 
developers of vaccines, monoclonal antibodies, drugs, and other potential interventions for COVID-19 
treatment and prevention. It also leverages the multidisciplinary expertise of investigators and staff in 
the networks, including clinical trial design and implementation, laboratory, and statistical expertise. 
In addition, the networks have research sites that allow for rapid enrollment of participants at 
traditional and non-traditional venues in the US and globally. The engagement of research sites from 
multiple NIH networks, including the HPTN, HVTN, ACTG and IMPAACT and the Infectious 
Diseases Clinical Research Consortium (IDCRC), will accelerate recruitment, diversify the trial 
cohorts, and build capacity for the conduct of future COVID-19 treatment and prevention studies. In 
this protocol, the terms “clinical research site (CRS)” and “research site” and “site” refer to clinical 
research sites from selected NIAID networks and “community” refers to the geographic area 
surrounding each CRS.   
 
The COVID-19 pandemic is evolving, with diverse and dynamic impacts in different regions and 
populations in the US Over the coming months and years, it is likely that different communities will 
experience the epidemic to varying extents, with resurgence in other communities. The beginning of 
the US epidemic was marked by an outbreak at a nursing home near Seattle, Washington (1) and 
nursing homes in many other states have had similarly tragic experiences with extremely high 
incidence and mortality rates (2). The nursing home outbreaks reflect the observation, now noted in 
multiple settings (2), that COVID-19 is more likely to present as a severe infection among those over 
the age of 65 and those with medical co-morbidities (3) and mortality rates are approximately ten 
times higher for these groups, even among those not living in a skilled nursing facility. These 
morbidity and mortality patterns among older individuals with medical conditions underscore the 
importance of treatment and prevention interventions tailored to this population. Accurate and detailed 
estimates of SARS-CoV-2 seroprevalence and COVID-19 in a rigorously sampled and geographically 
broad population will inform the development of these interventions.   
 
The epidemic has also been marked by harsh disparities in COVID-19 rates and other health outcomes 
among African American and Latino communities who have substantially higher attack rates and 
higher mortality compared with any other racial or ethnic group (4) across the US The communities 
surrounding several NIAID CRSs have suffered from not only longstanding racial inequalities, but 
also socioeconomic disparities in housing and employment, as well as varied access to health and other 
essential services. These populations also have a high prevalence of co-morbidities associated with 
higher incidence of COVID-19 (5-8) , more severe manifestations of COVID-19 disease (9-11), higher 
mortality from COVID-19 (11), and have poorer health outcomes from a variety of illnesses overall 
(12). As with the observations among the elderly, these racial and ethnic factors all compel the need 

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for the systematic collection of COVID-19-related data from populations at high risk for and highly 
impacted by COVID-19 and from the general population in their communities to enable the successful 
design and conduct of COVID-19 targeted prevention and treatment studies and provision of access to 
these populations of promising prevention and treatment interventions.  
 
The proposed research will provide comprehensive information on communities impacted by COVID-
19 beyond surveillance studies currently in the field (see Appendix IV for summary of existing 
studies). It will directly contribute to preparedness for SARS-CoV-2 vaccine and other COVID-19 
prevention studies by determining the prevalence of SARS-CoV-2 infection and seroprevalence among 
samples of individuals of different ages who are recruited from communities where NIAID CRSs are 
situated. All prevalence estimates will be weighted for study design, non-response and post-
stratification population projections in order to generate estimates that are representative of the NIAID 
CRS communities. This research will determine the extent to which children and adults in these areas 
have SARS-CoV-2 infection or evidence of prior SARS-CoV-2 infection (based on results of antibody 
tests, self-report, and medical records). Additionally, data captured through questionnaires about 
participants’ household members with COVID-like illness and deaths, combined with serologic data 
from participants, may also provide information about transmission dynamics within households. 
Questionnaire data will inform estimates of the percent of individuals of different age groups, 
including children, who may have had an asymptomatic COVID-19 infection. The frequency of 
infection among children and whether infected children play an important role in community 
transmission is poorly understood (13) . The study will also provide estimates of the association of 
SARS-CoV-2 seroprevalence with medical co-morbidities that have been associated with more severe 
disease outcomes and will also identify demographic and social risk factors associated with infection 
(10). Finally, this research will provide important information about SARS-CoV-2 transmission, 
COVID-19 disease, attitudes about and uptake of containment and mitigation measures, racial and 
ethnic health disparities, varied access to testing and public health resources by key demographic 
indicators, prospects for new prevention and treatment strategies, and be used to inform mathematical 
models of disease progression and projection of future COVID-19 risk. 
 
Other SARS-CoV-2 studies that are ongoing in the US use different sampling approaches and/or 
assess different populations (see Appendix IV). For example, the NIH’s ongoing “SARS-CoV-2 
Pandemic Serosurvey and Blood Sampling,” (NCT04334954) will estimate the number of adults over 
the age of 18 years with SARS-CoV-2 antibody among those who have not had confirmed COVID-19 
or known exposure to COVID-19. The study uses non-probability sampling to assemble a cohort of 
15,000 adults from three locations (Bethesda MD, Birmingham AL and Pittsburgh PA). The ongoing 
study has a longitudinal component as participants can re-enroll up to four times if more than 30 days 
have elapsed since their last enrollment.  
 
In contrast, the current study uses time-location sampling to assess cohorts that are representative of 
the communities near NIAID research sites across the US; includes young children and adolescents as 
well as adults; includes a detailed assessment of older adults with medical co-morbidities, including 
those residing in skilled nursing facilities; estimates the number and proportion with active infection as 
well as both symptomatic and asymptomatic prior infection; and will provide a more detailed picture 
of the racial and ethnic profile of the COVID epidemic in the US. 
 
In summary, this study will provide critically important information on the prevalence of current and 
prior SARS-CoV-2 infections in communities in the US where NIAID research sites are situated. It 
will assess the impact of COVID-19 on the communities, model the potential impact of different 
prevention interventions, and set the foundation for COVID-19 prevention and treatment trials in these 
communities. It will also provide critical information to guide site section and the allocation of 
numbers of participants for future prevention and treatment studies and will provide valuable samples 
for key laboratory assessments related to SARS-CoV-2 infection and the COVID-19 epidemic. 

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1.2 
Study Design 
 
Sites will be selected from existing NIAID CRSs. For most metropolitan areas, one CRS will be 
selected with consideration given to the population they serve. For larger metropolitan areas (e.g., New 
York, Chicago, Los Angeles), two or more CRSs may be selected to gain full representation of the 
region. Adjustments may be made to the selected CRSs as the dynamics of the pandemic shift.  
 
The study will begin with community consultations with existing site community advisory boards and 
key stakeholders, including relevant experts from local health departments, local healthcare and social 
service providers, and caregivers for elderly and chronically ill populations. These consultations will 
help identify specific venues, key community attributes, appropriate social venues, and times and days 
when venues are likely to be well populated. The consultations will also include discussions about how 
best to report results of SARS-CoV-2 RNA testing, to local health departments, as required by health 
regulations. Advice will be sought from the community advisory boards to help develop 
communication and social mobilization plans that ensure high participation rates.  
 
The study is observational in design with a single study visit. Recruitment, enrollment, and data 
collection will take place using two strategies: facility-based surveys of senior living facilities and 
time-location sampling (TLS) surveys of outpatient clinics and community venues. Facility-based 
surveys will begin with each research site creating a list of nearby senior living facilities that are 
interested in participating in the study. A census of all participating senior living facilities will be 
conducted to recruit up to 500 individuals per research site. Consent will be obtained from legal 
guardians for participants who are not able to provide consent.  Medical abstraction will be performed 
for these participants in lieu of administering the study questionnaire.  
 
Adults attending outpatient medical clinics and members of the general population attending 
community venues will be recruited through TLS. TLS is a well-established study methodology that 
uses ethnographically-informed mapping of social spaces to create a “clinic-time-day universe” or 
“venue-time-day universe” of commercial establishments, social service providers, schools, places of 
worship, parks, and transit hubs from which a given population can be systematically approached and 
surveyed (14). The approach is appropriate to reach a representative sample of individuals 
participating in social activities and interactions in the study communities.  
 
Adults who were recruited at a selected clinic or venue, have the capacity for consent and are willing 
and able to answer a brief survey and provide a blood sample and nasal mid-turbinate swab, will be 
included in the study. Children aged 2 months - 17 years will be included, with the consent of their 
parent or legal guardian and their assent from youth 7 – 17 years of age; the parent/guardian will 
complete the questionnaire for those under age 10 years and will assist those ages 11-15. These 
inclusion criteria allow for sampling of all populations impacted by the COVID-19 pandemic, 
including residents with chronic diseases such as obesity, hypertension, and diabetes, which have been 
shown to increase severity and mortality in COVID-19 patients. Data collection from 
parents/guardians about their children is also critical for understanding the prevalence of COVID-19 in 
younger patients, to understand the role children of different ages may play in household and 
community transmission dynamics and to learn about factors that may put some children at increased 
risk. 
 
 

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STUDY OBJECTIVES AND ENDPOINTS 
 
2.1 
Primary Objective and Endpoint 
 
Primary Objective 
Primary Endpoint 
To estimate the prevalence of SARS-CoV-2 
IgG seropositivity among individuals in 
communities surrounding selected NIAID 
clinical research sites  
Proportion of individuals who have SARS-
CoV-2 IgG antibodies, evaluated overall and 
by age strata, in the following populations: 
1) Adults 18 and older residing in senior 
living facilities  
2) Adults 18 and older attending outpatient 
healthcare clinics, and 
3) Individuals in communities of selected 
research sites in the following age 
categories 
a. 2 months – 17years old 
b. 18-39 years old 
c. 40-59 years old 
d. 60 years and older 
 
 
2.2 
Secondary Objectives and Endpoints 
 
Secondary Objectives 
Secondary Endpoints 
1) To estimate prevalence of SARS-CoV-2 
infection based on results of SARS-CoV-2 
RNA testing  
Proportion of individuals with SARS-CoV-2 
infection (based on SARS-CoV-2 RNA 
testing) 
2) To estimate prevalence of SARS-CoV-2 
infection by presence versus absence of 
symptoms consistent with COVID-19                
Proportion of individuals with SARS-CoV-2 
infection (based on SARS-CoV-2 RNA 
testing) who report lack of symptoms versus 
presence of symptoms consistent with 
COVID-19  
3) To estimate seroprevalence of SARS-
CoV-2 among:  
 
a) Those without past or current 
symptoms consistent with COVID-19,  
b) Those with no prior positive SARS-
CoV-2 testing, but who report close 
contact with confirmed or presumed 
cases, and 
c) Those with history of co-morbid 
medical conditions  
Proportion of individuals with SARS-CoV-2 
IgG antibodies who report: 
a) Prior confirmed or presumed COVID-19 
vs. those who report never having 
symptoms,  
b) No prior COVID-19 but who report 
close contact with a COVID-19 case (as 
defined by the US Centers for Disease 
Control and Prevention), and  
c) Co-morbid medical conditions such as 
obesity, hypertension and diabetes  

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Secondary Objectives 
Secondary Endpoints 
4) To assess association between 
demographic, clinical and social factors 
with SARS-CoV-2 infection and 
seroprevalence  
Socioeconomic, demographic and clinical 
correlates of COVID-19 and/or SARS-CoV-2 
seroprevalence with particular interest in 
racial and ethnic health disparities   
5) To estimate potential size of 
populations for referral to COVID-19 
prevention and treatment studies 
Extrapolated population sizes of  
a) Those with active COVID-19,  
b) Those who have serologic evidence of 
recent and/or past SARS-CoV-2 
infection, and  
c) Those who have negative RNA and 
serologic SARS-CoV-2 tests 
6) To assess knowledge, attitudes, and 
behavior about SARS-CoV-2 and 
COVID-19 
Knowledge and attitudes about SARS-CoV-2 
and COVID-19, and uptake of public health 
interventions including shelter in place orders, 
social distancing, and mask use   
7) To assess performance characteristics of 
PCR-based and serologic SARS-CoV-2 tests 
using saliva  
a) Estimates of sensitivity, specificity, 
and concordance of SARS-CoV-
assays using saliva samples, 
compared to nasal swab and serum 
samples  
b) Estimates of sensitivity and 
specificity of SARS-CoV-2 IgG 
serologic assays using saliva samples, 
compared to serum samples 
 
 
2.3 
Exploratory Objectives 
 
Exploratory Objective 1: 
• 
To model epidemiologic impact over time of COVID-19 in the study communities, including 
modeled incidence and prevalence of COVID-19.  
 
Exploratory Objective 2: 
• 
To conduct laboratory testing in a subset of participants to characterize SARS-CoV-2 viruses 
and the host response to SARS-CoV-2 infection, which may include detection of anti-SARS-
CoV-2 IgM antibodies. This testing may also include phylogenetic analysis of SARS-CoV-2 
and co-infections with other viruses, including viruses that impact the specificity of SARS-
CoV-2 serologic assays. 
 
 
STUDY POPULATION 
 
The study population will consist of adults residing in senior living facilities or attending outpatient 
healthcare facilities, and adults and children in select neighborhoods of research site communities. 

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Study staff will be in full personal protective equipment to minimize transmission risks and mitigate 
access restrictions. Masks will be offered to all participants who are not wearing them. Tablets, seating 
areas, and other surfaces will be sanitized with appropriate disinfectants between study participants. 
Each site will be required to document risk mitigation procedures in site standard operating procedures 
or other procedures manuals.  
 
3.1 
Inclusion Criteria 
 
 
Adults residing in senior living facilities or attending outpatient healthcare facilities 
 
3.1.1.1 
At least 18 years of age 
 
3.1.1.2 
Willing and able to provide informed consent or consent has been provided by legal 
representative (for those with mental incapacity in senior living facilities) 
 
3.1.1.3 
Recruited from a selected facility 
 
 
Adults and children from select neighborhoods of research site communities 
 
3.1.2.1 
Adults and children > 2 months of age 
 
3.1.2.2 
For individuals < 18 years old, a guardian must be present (in person or by phone for 
those 15 – 17 years old) 
 
3.1.2.3 
Willing and able to provide consent (or assent for individuals 7-17 years old, 
parent/guardian will provide consent for all minors) 
 
3.1.2.4 
Recruited from a selected venue 
 
3.2 
Exclusion Criteria 
 
 
Previous enrollment in this study, either from the same or another CRS community. 
 
 
Any condition that, in the opinion of the study staff, would make participation in the study 
unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving 
the study objectives. 
Note – COVID-19 vaccination is not exclusionary 
 
3.3 
Recruitment Process 
 
Each CRS will be responsible for enrolling up to 3,920 individuals. This will include a combination of 
community venues, healthcare facilities, and senior living facility residents. Most sites will enroll from 
all three populations whereas others may enroll from one or two, depending on capacity, however all 
sites must enroll participants from the community venues. Each study site will tailor community 
engagement and recruitment strategies to local circumstances and strategies using the recruitment 
guidelines outlined below and the Study Specific Procedures (SSP) Manual in order to maximize 
enrollment. Sites will be expected to work closely with community-based organizations or other 
appropriate groups with ties to the study communities. 
 

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Sampling Design and Recruitment at Community Venues  
 
The initial sampling “universe” – the list of target venues in the catchment area of the CRS – is 
comprised of venues routinely frequented by residents of the community. A venue could be retail 
businesses (e.g., laundromats, grocery stores), cafes and restaurants, health clubs, social service 
providers, schools, places of worship, transit hubs, parks, or beaches. Once this list (the “universe”) of 
potential venues is created, CRS staff will determine the suitability of each venue. A venue may not be 
suitable for sampling if any of the following are true:  
 
• 
It would be impossible logistically to recruit, interview and conduct study procedures.  
• 
Venue owner(s) refuse to allow the project staff access to venue attendees.  
 
Project staff will assess venue suitability by observing venues or informally talking to residents of the 
community and venue owners/managers. Time-location sampling will be used to select individuals 
who attend the population of suitable community venues in the catchment area during the overlapping 
operating hours of both the community venues and the CRS staff. For each catchment area, we first 
create a list of all suitable community venues and times that each venue is available in a given calendar 
period, e.g. week. Sampling will be performed in two stages. The first stage selects a stratified random 
sample of Venue Day Times (VDTs; approximate 4-hour time block that is available for recruitment at 
a specified venue). The second stage samples individuals from sampled VDTs (details outlined in the 
SSP Manual).  
 
 
Sampling Design and Recruitment at Outpatient Clinics 
 
Time-location sampling will be used to select individuals who attend suitable (where recruitment is 
feasible, and management is amenable) outpatient medical clinics in the catchment area during the 
overlapping operating hours of both the clinics and the CRS staff. Sampling will be performed in two 
stages. The first stage randomly selects Clinic Day Times (CDTs; approximate 4-hour time block that 
is available for recruitment at a specified clinic). The second stage samples individuals attending the 
clinic during the selected CDT (details outlined in the SSP Manual).  
 
 
Sampling Design and Recruitment at Senior Living Facilities  
 
Sample and recruitment will be undertaken using a convenience sample of n=500 individuals from the 
total population of individuals residing in interested and consenting senior living facilities (details 
outlined in the SSP Manual).  
 
3.4 
Participant Retention 
 
Study participation includes a single study visit either immediately following recruitment or at a later, 
scheduled date. In extenuating circumstances where a participant is unable to complete all procedures 
during one visit, a split visit can occur. Details are outlined in Section 4 of the SSP Manual.  
  
3.5 
Participant Withdrawal 
 
Participants may voluntarily withdraw from the study for any reason at any point during the study 
visit. The Investigator of Record (IoR) or designee may also withdraw participants from the study in 
order to protect their safety and/or if they are unwilling or unable to comply with required study 
procedures. Participants who withdraw from the study prior to completing the study procedures will be 
replaced. Study staff will record the reason(s) for all withdrawals from the study in participants’ study 
records. 

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3.6 
Community Definition 
 
The target venues for recruitment, enrollment, and data collection will be within the surrounding zip 
codes of the CRS. The protocol team will work with CRSs to select enough zip codes to include a 
specified number of residents that will allow for rapid enrollment of a representative sampling of the 
community. Details of the approach and documentation of the final selections will be documented in 
the SSP Manual.   
 
 
STUDY PROCEDURES 
 
An overview of the study visits and procedures is presented in Appendix I. Presented below is 
additional information on specific study procedures. Additional detailed instructions to guide and 
standardize all study procedures across sites will be provided in the SSP Manual. Study visits will 
either take place at the venue, in a location identified by study staff which assures adequate privacy 
and confidentiality, or at the CRS if an individual is interested in participating but unable to complete 
the study procedures at that moment. For visits occurring at community venues, tents or privacy 
screens will be erected to allow for privacy during visit procedures.   
 
Participants will be offered reimbursement for their time and effort via gift cards or other locally 
developed methods. Measures will be put into place to ensure staff safety in the field, such as gift card 
activation prior to use.       
 
4.1 
Informed Consent 
 
Independent informed consent will be obtained using encrypted electronic tablets from each 
participant before any study procedures are initiated. If electronic consent is not available, consent can 
be captured on paper. For more on informed consent, see Section 8.2.  
 
 
Recruitment and Screening  
 
Study field teams will consist of recruiters and research assistants, trained in study procedures and 
specimen collection, who will conduct data and specimen collection at specified venues and times. 
Recruiters will approach individuals with a brief explanation of the study and invite them to be 
screened for eligibility. A verbal consent will be administered and then staff will ask their age, if they 
are already enrolled in this study, and if they are interested in participating.  
 
Individuals will be informed that, in addition to receiving their test results, per local health codes, a 
positive SARS-CoV-2 diagnostic test result will be transmitted in a confidential manner to local health 
authorities. 
 
 
Protocol-Specific Consent Form 
 
Recruiters will obtain informed consent using encrypted electronic tablets; participants will receive a 
paper copy of the consent form. A sample protocol-specific consent form is located in Appendix II: 
Sample Informed Consent Form. (Paper consent may be collected if electronic consent is not 
available.) 
 
Each CRS is responsible for developing a protocol-specific consent form(s) for local use, based on the 
sample protocol-specific consent forms in Appendix II: Sample Informed Consent Form. The consent 
form(s) must be developed in accordance with requirements of the following: 

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26 May 2021 
• The single IRB (sIRB) 
• CRS’s institution, and 
• Elements of informed consent as described in Title 45, CFR Part 46 and Title 21 CFR, Part 50, 
and in ICH E6 (R2), Good Clinical Practice: Consolidated Guidance 4.8.  
 
Study sites are strongly encouraged to have their local Community, Resident or Staff Advisory 
Board(s) (as appropriate) review their site-specific consent forms. This review should include, but 
should not be limited to, issues of cultural competence, local language considerations, and the level of 
understandability. 
 
The sample informed consent form(s) (ICF[s]) include instructions for developing specific content.  
 
4.2 
Enrollment  
 
The point of enrollment into this study is when the participant signs the informed consent form. 
 
4.3 
Questionnaire Administration 
 
The questionnaire will be administered to each consenting participant (or to the parent of participants 
up to 9 years of age) using encrypted tablet computers or paper forms. Data collected will include 
basic demographic, socioeconomic, geographic, clinical, and household SARS-CoV-2 
exposure/infection history indicators. (The list of COVID symptoms is included as part of the 
questionnaire.) A brief knowledge and attitudes questionnaire will be administered to participants aged 
10 years or older. Individuals will be asked questions related to personal and community impact from 
COVID-19, such as loss of employment or housing, and access to basic resources and healthcare. The 
questionnaire will be tailored for age appropriateness.  
 
4.4 
Phlebotomy 
 
A small volume of venous blood ~6 mL for participants aged 2-6 years, ~10 mL for participants aged 
> 6 years or fingerstick to yield 1mL of blood  when staff have unsuccessful attempts at venous 
puncture (number of failed attempts defined in the SSP) ), and ~500uL of blood via heel or finger stick 
(heel stick recommended for participants 2-6 months and finger stick for participants 6 months to 2 
years old) will be collected from each participant by trained study staff and labeled with a study ID. 
Specimens will be kept in a temperature-controlled container at the venue until they are transported to 
a local laboratory. 
 
Dried blood spots, and plasma or serum aliquots will be prepared at the processing laboratory and 
stored.  Stored samples will be used for serologic testing and will also be stored for specialized SARS-
CoV-2 testing. Serologic testing will be performed retrospectively at the LC and/or other centralized 
network laboratories. The results of these tests will not be returned to study sites or participants.  
 
4.5 
Nasal Mid-Turbinate Swab Sample Collection 
 
SARS-CoV-2 RNA testing will be performed on nasal mid-turbinate swab samples for analysis at 
local laboratories using a testing platform approved by the LC. Procedures for sample collection and 
processing will be described in the SSP Manual.  
 
4.6 
Saliva Substudy  
 

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In a subset (approximately 1000) of participants, an additional nasal mid-turbinate swab and saliva will 
be collected as described in the SSP manual.  
 
4.7 
SARS-CoV-2 Counseling  
 
All study participants will receive counseling messages consistent with the US Center for Disease 
Control and Prevention (CDC) and local public health authorities. These messages will include 
instructions on use of masks and how to isolate from others, duration of isolation, how to monitor for 
worsening of symptoms, and how to connect to social services as needed. 
 
4.8 
SARS-CoV-2 Results Reporting 
 
Participants will be provided with instructions to retrieve the results of their SARS-CoV-2 RNA testing; 
those with positive test results will receive counseling about isolation and referral to care and will be 
reminded of plans to inform local health authorities for follow-up and contact tracing. Positive RNA 
results will be reported to local health authorities as per local health regulations. Serology results are for 
research purposes only and will not be returned to participants.  
 
4.9 
Medical Records Abstraction for Senior Living Facility Participants 
 
Medical record abstraction will occur for participants who are residents in senior living facilities and 
who have been consented by their legally authorized representative because of diminished cognitive 
capacity. Questionnaire domains will include history of chronic illnesses (e.g. diabetes, hypertension, 
asthma, etc.), smoking history, and prior SARS-CoV-2 diagnosis and will be comparable (when 
possible) to domains in the questionnaire.   
 
 
SAFETY MONITORING AND ADVERSE EVENT REPORTING 
 
As this is an observational study, standard adverse event (AE) reporting will not be undertaken. The 
study team will monitor for and track serious adverse events (SAEs) related to study procedures and/or 
to participation in the study. Such events that are unexpected will be reported to the NIAID Medical 
Officer at the same time as they are reported to IRBs according to pre-established written procedures, 
as required by 45 CFR 46. This information will not be recorded on case report forms (CRFs) or 
entered into the study database. Data on social harms will be collected as part of the overall assessment 
of participant safety.  
 
 
STATISTICAL CONSIDERATIONS 
 
6.1 
Review of Study Design 
 
This is a cross-sectional study of individuals residing within the vicinity of selected research sites in 
the United States who are (i) residing in senior living facilities, (ii) visiting outpatient clinics at given 
times; and (iii) members of the general population who attend any of the listed community venues at 
given times. The study aims to estimate prevalence of SARS-CoV-2 infection and IgG seropositivity 
separately in each of these populations (sampling strategies described above). Given that the three 
primary endpoints and their respective samples are independent, sites may recruit from one, two, or all 
three population groups, depending on site capacity (sites must enroll from at least the community 
venues). Consenting and assenting participants who satisfy the inclusion and exclusion criteria 
described in Section 3.0, will answer a brief survey and provide a blood sample and nasal mid-
turbinate swab(s).  

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6.2 
Sample Size 
 
The sample size is calculated for the primary objective, namely, to estimate the seroprevalence of 
SARS-CoV-2 among individuals and communities where potential COVID-19 vaccine or other 
prevention interventions studies may be prioritized.  
 
A sample of up to 500 senior living facility residents will be enrolled (described above).  
 
A separate sample of approximately 500 adults from outpatient clinical facilities will be selected 
according to a TLS design implemented as a two-stage random sample (described above). 
 
The sample size for the TLS sampling was determined based on the minimum sample size needed to 
achieve prespecified margin of error (MOE). This framework sets a tolerance, also called the margin 
of error (MOE) for how close we would like the estimated prevalence 𝑝̂ to be from the true population 
prevalence 𝑝. Denoting the MOE by e, this means 
𝑃𝑟(|𝑝̂ −𝑝| ≤𝑒) = 1 −𝛼. 
Assuming 𝑝̂  can be treated as normally distributed, this statement is equivalent to setting the half-
width of a 100(1 −𝛼)/ two-sided confidence interval to 𝑒= 𝑧1−𝛼/2√𝑉(𝑝̂) which results in a sample 
size of 
𝑛≈𝑧1−𝛼/2
2
𝑝(1 −𝑝)
𝑒2
 
Table 1 shows the sample sizes needed to achieve required sample sizes with +/-5% and +/-2.5% 
margin of error on estimated prevalence for a range of assumed prevalence of SARS-CoV-2 antibodies 
for simple random samples of infinite population size.  
Table 1. Sample Size requirement (per strata) to achieve +/- 5% and +/- 2.5% MOE for a range 
of assumed seroprevalence 
SARS prev 
0.02 
0.05 
0.1 
0.15 
0.2 
0.25 
+/- 5% MOE 
30 
73 
138 
196 
246 
288 
+/- 2.5% MOE 
120 
292 
553 
784 
983 
1152 
 
Table 2. Sample Size requirement (per strata) to achieve +/- 5% and +/- 2.5% MOE for a range 
of assumed seroprevalence after using a design effect of 2.5. 
SARS prev 
0.02 
0.05 
0.1 
0.15 
0.2 
0.25 
+/- 5% MOE 
75 
182 
346 
490 
615 
720 
+/- 2.5% MOE 
301 
730 
1383 
1959 
2459 
2881 
 
To estimate the prevalence of infection and seropositivity in each of four age strata (2 months-17, 18-
39, 40-59, 60+ years), we assumed the seroprevalence of SARS-CoV-2 may vary from 2.5% to 25%, 
and specified a margin of error (MOE) of 2.5% for prevalence below 5% and 5% MOE for prevalence 
between 10 and 25%, and assumed a design effect of 2.5 to account for clustering within social 

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networks of a venue. These values are shaded in Table 2 above and yield a maximum sample size of 
730 per stratum. 
 
6.3 
Statistical Analyses 
 
This section briefly describes the final study analyses. Detailed technical specifications of the 
statistical analyses will be described in a separate Statistical Analysis Plan (SAP). 
 
All statistical analyses will account for the sample design to create the base sampling weights. The 
sampling weights will be further adjusted for nonresponse and post-stratified using demographic 
information such as age, sec, race/ethnicity, education, and income. County-level estimates from the 
census bureau will be used for raking and post-stratification. We will estimate prevalence and calculate 
95% confidence intervals of SARS-CoV-2 infection and IgG seropositivity for each target population 
separately, i.e. among community residents in each of the age groups (2 months-17, 18-39, 40-59, 60+ 
years); among patients attending the outpatient clinics; and among senior living facility residents. 
 
 
Primary Analyses 
 
Design-based estimates using the survey weights will be used to estimate the overall prevalence of 
SARS-CoV-2 IgG seropositivity among individuals in each of the three target populations. Survey 
weights will be used to reflect the sampling design for each target population and post-stratified to 
census data on known demographic variables. Variance of the design-based estimates will be 
estimated using linearization-based and Jackknife methods. The design-based estimates and 
corresponding standard errors will be used to construct 95% confidence intervals. 
 
Prevalence estimates in each age group will be estimated using domain estimates implemented as ratio 
estimates in each subgroup.  
 
Sensitivity analysis may be considered to adjust for test sensitivity and specificity if prevalence is 
estimated to be lower than 5%. 
 
 
Secondary Analyses 
 
Prevalence estimates in each age group will be estimated using domain estimates implemented as ratio 
estimates in each subgroup (15) for Secondary Objectives 1-3 in Section 2.2.  
 
Logistic regression using survey weights will be used to infer associations between the hypothesized 
socioeconomic, demographic and clinical predictors of SARS-CoV-2 infection and seroprevalence 
described in Secondary Objective 4. Logistic regression using survey weights will also be used to infer 
associations between knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 
described in Secondary Objective 6 with uptake of public health interventions including shelter in 
place orders, social distancing, and mask use. 
 
Design-based survey estimates will also be used for Secondary Objective 5 to estimate the size of the 
populations with potential for referral to COVID-19 prevention and treatment trials. Performance 
characteristics of the serological and antibody tests will be specific to the substudy and will not 
account for the sampling design.  
 
 
 
 

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LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT 
 
7.1 
Specimen Collection 
 
Specimens collected during study visits are specified in Appendix I: Schedule of Evaluation and 
Procedures, and include: 
 
1) Up to 10 mL blood (500 uL for participants 2 months to 2 years, ~6 mL for participants aged 2-6 
years, ~10 mL for participants aged >6 years, or 1 mL from fingerstick after unsuccessful venous 
puncture attempts)) 
2) Note: Dried blood spots will be prepared at the local laboratory for participants less than 2 years of 
age or for participants >2 years with unsuccessful venous puncture attempts  
3) Nasal mid-turbinate swabs  
4) Saliva and additional nasal swab samples (subset of participants in saliva substudy) 
 
Specimen collection procedures are described in the SSP Manual. Nasal and saliva sample collection 
are described in the clinical section of the SSP Manual.  
 
7.2 
CRS Lab Procedures 
 
The SSP Manual provides further guidelines for operational issues concerning the clinical and 
processing laboratories. These documents include guidelines for specimen collection, special 
considerations for phlebotomy, specimen labeling, whole blood processing, SARS-CoV-2 
screening/RNA testing, and general screening. 
 
 All assays described below with the exception of SARS-CoV-2 RNA testing done at local clinical 
reference laboratories will be performed for research use only. Individual participant level results from 
these assays will not be made available to study sites or participants.  
 
7.3 
Endpoint Assays 
 
For SARS-CoV-2 infection, RNA testing will be performed using nasal mid-turbinate swabs at local or 
clinical reference laboratories using a laboratory platform approved by the LC.  
 
For SARS-CoV-2 seroprevalence, SARS-CoV-2 specific IgG antibodies will be evaluated in 
centralized laboratories approved by the LC using assays that are Food and Drug Administration 
(FDA)-approved or have Emergency Use Authorization (EUA) from the US FDA. The SARS-CoV-2 
specific IgG antibody assay employed will target the viral nucleocapsid protein.  
 
7.4 
Exploratory Studies 
 
Samples may also be used to conduct specialized laboratory testing. This testing will be performed 
using samples from a subset of study participants. This testing may include characterization of SARS-
CoV-2 viruses; phylogenetic analysis; detection of anti-SARS-CoV-2 IgM antibodies; evaluation of 
CoV-2 assays using alternate sample types; characterization of the host response to SARS-CoV-2 
infection; viral neutralization assays; and the prevalence of co-infections with other viruses, including 
viruses that may impact the specificity of COVID-19 serologic assays. 
 
Samples may also be used for other testing and research related to furthering the understanding of 
SARS-CoV-2 immunology and virology, including, but not limited to, antibody-mediated anti-viral 
activities, and antibody dependent enhancement; monoclonal antibodies and antibody-mediated 

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prevention; or vaccines. In addition, samples may be used to perform additional assays to support 
standardization and validation of existing or newly-developed test methods. 
 
7.5 
Specimen Storage and Other Use of Specimens 
 
Specimens will be stored for at least one year after the primary manuscript has been published.  
 
Other use of specimens is defined as studies not covered by the protocol or the informed consent form 
for the main study (see Appendix II: Sample Informed Consent Form: Sample Informed Consent 
Form).  
 
This research may relate to SARS-CoV-2, COVID-19, vaccines, antibodies, the immune system, and 
other diseases. This research is done only to the extent authorized in each study site’s informed 
consent form, or as otherwise authorized under applicable law. Other research on specimens (“other 
use”) will occur only after review and approval by the CoVPN, the IRB of the researcher requesting 
the specimens, and the sIRB, if required.  
 
As part of consenting for the study, participants document their initial decision to allow or not allow 
their specimens to be used in other research, and they may change their decision at any time. The 
participant’s initial decision about other use of their specimens, and any later change to that decision, 
are documented in the study database. The Network will only allow other research to be done on 
specimens from participants who allow such use.  
 
CRSs must notify the leadership and operations center (LOC) if institutional or local governmental 
requirements pose a conflict with or impose restrictions on specimen storage or other use of 
specimens. 
 
7.6 
Biohazard Containment 
 
The transmission of blood-borne pathogens can occur through contact with contaminated needles, 
blood, and blood products, and the transmission of SARS-CoV-2 and other respiratory pathogens may 
occur through contact with contaminated respiratory droplets and aerosols. Appropriate precautions 
will be employed by all personnel in the collection, shipping and handling of all specimens for this 
study, as currently recommended by the CDC and the NIH or other applicable agencies. 
 
All dangerous goods materials, including Biological Substances, Category A or Category B, must be 
transported according to instructions detailed in the International Air Transport Association Dangerous 
Goods Regulations. 
 
 
HUMAN SUBJECTS CONSIDERATIONS 
 
The CoVPN Prevalence Study will rely on the existing DAIDS guidelines regarding human subjects 
considerations to maintain compliance with the expectation of NIAID sponsored clinical research 
studies.    
 
8.1 
Ethical Review  
 
This protocol and the template ICF(s) contained in Appendix II: Sample Informed Consent Form: 
Sample Informed Consent Form, and Appendix III: Sample Verbal Pre-Screening Script, will be 
reviewed and approved by the NIAID Prevention Science Review Committee (PSRC) with respect to 
scientific content and compliance with applicable research and human subjects’ regulations.  

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The protocol, site-specific ICFs, participant education and recruitment materials, other requested 
documents, and any subsequent modifications will be reviewed and approved by an sIRB.  
 
Subsequent to initial review and approval, the responsible sIRB will review the protocol at least 
annually. Safety and progress reports will be made to the sIRB, as required, at least annually, and 
within three months of study termination or completion. These reports will include the total number of 
participants enrolled in the study, the number of participants who completed the study, all changes in 
the research activity, and must comply with the requirements of 45 CFR 46.108(a)(4) and 21 CFR 
56.108b for promptly reporting the following: all unanticipated problems involving risks to human 
subjects or others; serious or continuing noncompliance with applicable regulations or the 
requirements or determinations of their IRBs/ECs; and any suspension of termination of IRB approval. 
Documentation of continuing review will be submitted to the DAIDS PRO, in accordance with the 
current DAIDS Protocol Registration Policy and Procedure Manual.  
 
8.2 
Informed Consent 
 
Informed consent will be obtained from each study participant using encrypted electronic tablets. 
Paper copies will be offered to participants who choose to take a copy with them. Each study site is 
responsible for developing informed consent language for local use, based on the templates in 
Appendix II: Sample Informed Consent Form: Sample Informed Consent Form, which describes the 
purpose of the study, the procedures to be followed, and the risks and benefits of participation, in 
accordance with all applicable regulations. If applicable, the study site also is responsible for 
translating the template form into local languages and verifying the accuracy of the translation by 
performing an independent back-translation.  
 
Literate participants will document their provision of informed consent by signing their ICF. Non-
literate participants will be asked to document their informed consent by marking their ICFs (e.g., with 
an X, thumbprint, or other mark) in the presence of a literate third-party witness. (Further details 
regarding DAIDS requirements for documenting the informed consent process with both literate and 
non-literate participants are provided in the DAIDS Standard Operating Procedure for Source 
Documentation.) Any other IRB requirements and site SOPs for obtaining informed consent from non-
literate persons also will be followed.  
 
For potential participants who are not of legal age, the parent or guardian will provide permission and 
the minor (7-17 years old) will provide assent. 
 
For individuals with diminished cognitive capacity, study staff will explain the nature of the study, 
including the risks and benefits, to the participant’s legally authorized representative (LAR), and to the 
extent possible to the participant, and answer all questions regarding the study. The LAR and the 
participant will be informed that their participation is voluntary. The LAR will complete an electronic 
informed consent that meets all applicable local and regulatory requirements. Due to strict COVID-19 
prevention measures in senior living and healthcare facilities, alternative methods of obtaining consent 
from LARs (for example, by phone) will be allowed if approved by the IRB. Study staff will document 
the consent process in the participants’ files for all enrolled participants.  
 
The study staff member obtaining the informed consent and, if applicable, the individual designated to 
witness a verbal consent, must also sign the ICF. The participant or LAR must complete a 
comprehension assessment prior to signing the consent form.  
 

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8.3 
Risks 
 
Nasal swabs may cause minor nasal irritation and sneezing and rarely results in a nosebleed. 
 
Venipuncture is sometimes associated with discomfort, dizziness, and rarely, an infection at the site of 
phlebotomy. Participants may become embarrassed, worried, or anxious when completing the survey. 
They may also become worried or anxious while waiting for their test results. Study staff will be 
trained to help participants deal with these feelings and provide them with resources  
 
Participants who learn that they have SARS-CoV-2 infection, may experience anxiety related to their 
test results.  
 
All study staff will be provided with personal protective equipment and will be required to have 
received training in Good Clinical Practices and Human Subject Protection according to DAIDS 
policies and procedures. Although study sites will make every effort to protect participant privacy and 
confidentiality, it is possible that participants' involvement in the study could become known to others, 
and that social harms may result because of presumed or confirmed SARS-CoV2 infection.  
 
8.4 
Benefits 
 
Participants will receive SARS-CoV-2 RNA test results.  
 
There may be no direct benefits to participants in this study, however, participants and others may 
benefit in the future from information learned from this study.  
 
8.5 
Compensation 
 
Pending IRB approval, participants will be compensated for their time and effort in this study. Site-
specific reimbursement amounts will be specified in the study ICFs.  
 
8.6 
Confidentiality 
 
All study-related information will be stored securely at the study site. All participant information will 
be stored in locked file cabinets in areas with access limited to study staff. All laboratory specimens, 
reports, study data collection, process, and administrative forms will be identified by a coded number 
only to maintain participant confidentiality. All local databases will be secured with password-
protected access systems. Forms, lists, logbooks, appointment books, and any other listings that link 
participant ID numbers to other identifying information will be stored in a separate, locked file in an 
area with limited access. 
 
Participant’s study information will not be released without the written permission of the participant, 
except as necessary for monitoring by NIAID and/or its contractors; representatives of the study’s 
LOC, SDMC, and/or LC, and the sIRB.  
 
NIAID has Certificates of Confidentiality from the US Department of Health and Human Services that 
is applicable to this study. Certificates cover all study sites conducting this research, regardless of the 
country where the investigator or the protected information resides. This Certificate protects study 
staff from being compelled to disclose study-related information held in the US, by any Federal, State 
or local civil, criminal, administrative, legislative, or other body.  
 

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8.7 
Communicable Disease Reporting Requirements 
 
Study staff will comply with all applicable local requirements to report communicable diseases 
(including SARS-CoV-2 infections, where required) identified among study participants to local health 
authorities. Participants will be made aware of all reporting requirements during the study informed 
consent process. 
 
8.8 
Study Discontinuation 
 
The study may also be discontinued at any time by NIAID, the CoVPN, the sIRB or other government 
or regulatory authorities. 
 
ADMINISTRATIVE PROCEDURES 
 
The CoVPN Prevalence Study will rely on the existing DAIDS structures to execute administrative 
procedures that are in compliance with the expectation of NIAID sponsored clinical research studies.    
 
9.1 
Protocol Registration  
 
Initial Registration of the protocol by the DAIDS PRO is required prior to the implementation of this 
protocol. As part of this process, each site must have the protocol and protocol ICF(s) approved, as 
appropriate, by the sIRB. Upon receiving final approval, sites will submit all required protocol 
registration documents to the DAIDS PRO at the DAIDS Regulatory Support Center (RSC). The 
DAIDS PRO will review the submitted protocol registration packet to ensure that all of the required 
documents have been received. In the case of Initial Registration, site-specific ICFs WILL be reviewed 
and approved by the DAIDS PRO. Sites will receive an Initial Registration Notification from the 
DAIDS PRO that indicates successful completion of the protocol registration process. A copy of the 
Initial Registration Notification should be retained in the site's regulatory files. 
 
Following Initial Registration, any full protocol amendments require submission of a protocol 
registration packet to the DAIDS PRO as described above; however, the DAIDS PRO WILL NOT 
review and approve site-specific ICFs. Sites will receive a Registration Notification when the DAIDS 
PRO receives a complete registration packet. Upon receiving final IRB/EC and any other applicable 
regulatory approval(s) for an amendment, sites should implement the amendment immediately. 
 
For additional information on the protocol registration process and specific documents required for 
initial and amendment registrations, refer to the current version of the DAIDS Protocol Registration 
Manual online.  
 
9.2 
Study Activation 
 
Pending successful protocol registration and submission of all required documents, the LOC staff will 
“activate” a site. Study implementation may not be initiated until a study activation notice is provided 
to the site by the LOC. In addition, if study activation is determined to be necessary for any subsequent 
amendments, study implementation may not be initiated until a study activation notice is provided to 
the site by the LOC. 
 
9.3 
Study Coordination 
 
Study implementation will be directed by this protocol as well as the SSP Manual.  The SSP Manual 
— which will contain links to the Requirements for Source Documentation in DAIDS Funded and/or 
Sponsored Clinical Trials, as well as the DAIDS Manual for Expedited Reporting of Adverse Events 

CoVPN 5002, Version 2.0 
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to DAIDS and the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events— 
will outline procedures for conducting study visits; data and forms processing; AE assessment, 
management and reporting; and other study operations. 
  
Data collection instruments and other study-specific implementation materials will be developed by 
key members of the protocol team and SDMC. Data will be submitted to the SDMC for data cleaning, 
reporting and analysis. Data management and coding queries will be generated and applied to the data 
by SDMC staff on a routine basis for verification and resolution by site staff.   
 
Close coordination between protocol team members will be necessary to track study progress, respond 
to queries about proper study implementation, and address other issues in a timely manner. Rates of 
accrual and visit completion rates will be monitored closely by the team as well as  
the independent study monitoring committee.  
 
9.4 
Study Monitoring 
 
 Study monitoring will be performed at the discretion of and in accordance with DAIDS policies. 
Study monitors will: 
 
• 
Verify compliance with human subjects and other research regulations and guidelines;  
• 
Assess adherence to the study protocol, SSP Manual, and local counseling practices; and 
• 
Confirm the quality and accuracy of information collected at the study site and entered into the 
study database. 
• 
Verify compliance with Good Clinical Laboratory Practices 
 
Monitoring visits will be conducted on-site or remotely. Remote visits may include remote source 
document verification using methods specified for this purpose by NIAID. Remote monitoring visits 
may be performed in place of, or in addition to onsite visits to ensure the safety of study participants 
and data integrity (16). The site will make available study documents for site monitors to review 
utilizing a secure platform that is HIPAA and 21 CRF Part 11 compliant. Potential platform options 
include: Veeva SiteVault, site-controlled SharePoint or cloud-based portal, direct access to Electronic 
Medical Record (EMR), and Medidata Rave Imaging Solution. Other secure platforms that are 21 CFR 
Part 11 compliant may be utilized, as allowed by the DAIDS Office of Clinical Site Oversight 
(OCSO). For on-site visits site investigators will allow study monitors to inspect study facilities and 
documentation (e.g., ICFs, clinic and laboratory records, other source documents, paper or electronic 
CRFs), as well as observe the performance of study procedures. Investigators also will allow 
inspection of all study-related documentation by authorized representatives of the study’s LOC, 
SDMC, and LC, as well as NIAID, the sIRB and US regulatory authorities (Office for Human 
Research Protections (OHRP) or other regulatory agencies). A site visit log will be maintained at each 
study site to document all visits.  
 
9.5 
Protocol Compliance 
 
The study will be conducted in full compliance with the protocol. The protocol will not be amended 
without prior written approval by the Protocol Chairs and sponsor. All protocol amendments must be 
submitted to the DAIDS RSC and approved by the relevant IRB(s) prior to implementing the 
amendment. 
 
 

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9.6 
Investigator’s Records 
 
The IoR will maintain, and store in a secure manner, complete, accurate, and current study records 
throughout the study. The IoR will retain all study records for at least three years after the completion 
of research.  
 
Completion of a clinical research study occurs when the following activities have been completed: 
 
• 
All research-related interventions or interactions with human subjects (e.g., when all subjects 
are off study);  
• 
All protocol-required data collection of identifiable private information described in the IRB-
approved research plan;  
• 
All analysis of identifiable private information described in the IRB-approved research plan;  
• 
Primary analysis of either identifiable private or de-identified information.  
 
Study records include administrative documentation — including protocol registration documents and 
all reports and correspondence relating to the study — as well as documentation related to each 
participant screened and/or enrolled in the study — including ICFs, locator forms, eCRFs, notations of 
all contacts with the participant, and all other source documents. 
 
9.7 
Use of Information and Publications 
 
Publications, presentations or dissemination of results should be reviewed by a CoVPN publications 
committee and NIAID prior to submission or release of any results. 
 
9.8 
ClinicalTrials.gov 
 
This study is subject to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information. A description of this clinical trial will be available on www.ClinicalTrials.gov. 
 
 

CoVPN 5002, Version 2.0 
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REFERENCES 
 
1. 
McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, et al. Epidemiology 
of Covid-19 in a Long-Term Care Facility in King County, Washington. New England Journal of Medicine. 
2020;382(21):2005-11. 
2. 
COVID-19 Nursing Home Data [Internet]. 2020 [cited 06/08/2020]. Available from: 
https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg. 
3. 
CDC. Coronavirus Disease 2019 (COVID-19): Groups at Higher Risk for Severe Illness 2020 
[updated 05/14/2020. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-
precautions/groups-at-higher-risk.html. 
4. 
Millett GA, Jones AT, Benkeser D, Baral S, Mercer L, Beyrer C, et al. Assessing Differential 
Impacts of COVID-19 on Black Communities. Annals of epidemiology. 2020. 
5. 
Fei K, Rodriguez-Lopez JS, Ramos M, Islam N, Trinh-Shevrin C, Yi SS, et al. Racial and 
Ethnic Subgroup Disparities in Hypertension Prevalence, New York City Health and Nutrition Examination 
Survey, 2013-2014. Preventing chronic disease. 2017;14:E33. 
6. 
Osei K, Gaillard T. Disparities in Cardiovascular Disease and Type 2 Diabetes Risk Factors in 
Blacks and Whites: Dissecting Racial Paradox of Metabolic Syndrome. Frontiers in endocrinology. 
2017;8:204. 
7. 
Petersen R, Pan L, Blanck HM. Racial and Ethnic Disparities in Adult Obesity in the United 
States: CDC's Tracking to Inform State and Local Action. Preventing chronic disease. 2019;16:E46. 
8. 
Vahidy FS, Nicolas JC, Meeks JR, Khan O, Jones SL, Masud F, et al. Racial and Ethnic 
Disparities in SARS-CoV-2 Pandemic: Analysis of a COVID-19 Observational Registry for a Diverse US 
Metropolitan Population. medRxiv. 2020:2020.04.24.20073148. 
9. 
Gold JAW, Wong KK, Szablewski CM, Patel PR, Rossow J, da Silva J, et al. Characteristics 
and Clinical Outcomes of Adult Patients Hospitalized with COVID-19 - Georgia, March 2020. MMWR 
Morbidity and mortality weekly report. 2020;69(18):545-50. 
10. 
Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW, et al. 
Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 
in the New York City Area. JAMA. 2020;323(20):2052-9. 
11. 
New York City Department of Health and Mental Hygiene. Age-adjusted rates of lab 
confirmed COVID-19 non hospitalized cases, estimated non-fatal hospitalized cases, and patients known to 
have died 100,000 by race/ethnicity group as of April 16, 2020 2020 [ 
12. 
Myers C, Olson C, Kerker B, Thorpe L, Greene C, Farley T. Reducing health disparities in 
New York City: health disparities in life expectancy and death. 2010. 
13. 
CDC COVID-19 Response Team. Coronavirus Disease 2019 in Children - United States, 
February 12-April 2, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(14):422-6. 
14. 
Karon JM, Wejnert C. Statistical methods for the analysis of time-location sampling data. 
Journal of urban health : bulletin of the New York Academy of Medicine. 2012;89(3):565-86. 

CoVPN 5002, Version 2.0 
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15. 
Lumley T, Kronmal R, Ma S. Relative risk regression in medical research: models, contrasts, 
estimators, and algorithms. 2006. 
 
16. FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public 
Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards, March 2020, 
Updated on January 27, 2021. Accessed at: https://www.fda.gov/media/136238/download 
 
 
 
 
 
 
 
 

CoVPN 5002, Version 2.0 
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APPENDIX I: SCHEDULE OF EVALUATIONS AND PROCEDURES 
 
 
 
 
 
Pre-screening 
Screening 
Enrollment 
Administrative and Behavioral Evaluations/Procedures 
 
 
 
Eligibility pre-screening 
X 
 
 
Screening and Enrollment informed consent  
 
X 
 
Demographic and clinical information 
 
 
X 
Questionnaire administration 
 
 
X 
COVID-19 risk reduction counseling 
 
 
X 
Clinical Evaluations/Procedures 
 
 
 
POC COVID-19 testing with return of results (if available)  
 
 
X 
Collection of nasal mid-turbinate swab* 
 
 
X 
Blood collection  
 
 
X 
Saliva collection (subset of participants) 
 
 
X 
Laboratory Evaluations/Procedures 
 
 
 
Local testing: 
 
 
 
SARS-CoV-2 RNA testing (nasal mid-turbinate swab)  
 
 
X 
Serum storage for SARS-CoV-2 antibody testing and characterization of the 
serologic response to SARS-CoV-2 infection; and other testing (see Section 
7.4) 
 
 
X 
Dried blood spot storage for SARS-CoV-2 antibody testing and 
characterization of the serologic response to SARS-CoV-2 infection; and 
other testing, when tests are validated (see Section 7.4) ** 
 
 
X 
Nasal swab mid-turbinate storage* for the saliva substudy 
 
 
X 
Saliva sample storage (subset of participants) 
 
 
X 
 
*A duplicate set of nasal swab samples is needed for storage in the Saliva substudy in a subset of participants who are selected 
at two sites.  
**DBS storage for participants 2 months to 2 years or >2 years that had unsuccessful venous puncture attempts prepared from 
capillary sample. 
 
 

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APPENDIX II: SAMPLE INFORMED CONSENT FORM 
 
CoVPN 5002 
 
SARS-COV-2 PREVALENCE STUDY 
  
Version 2.0 
26 May 2021 
DAIDS-ES ID: 38749 
 
Sponsored by: United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National 
Institutes of Health (NIH) 
 
Site: 
Principal Investigator: 
Phone: 
 
NOTE TO SITES: This sample consent form must be modified into three separate consent forms: (1) adults 
enrolling with no diminished cognitive capacity, that are able to consent on their own (2) minors, ages 7-17, 
enrolling from community venues, with consent of their guardian and their assent (signed on this form for ages 
14-17; signed on a separate, simplified assent form for ages 7-13, Appendix III) and (3) individuals with 
diminished cognitive capacity, with consent given by their legally authorized representative. Guidance is provided 
below, as needed.  
 
Consent form for minors, add: If you are a parent or legal guardian of a child participating on this study, 
throughout this document “you(r)” = “your child”. 
 
Consent form for adults with diminished cognitive capacity, add: If you are the legally authorized representative 
of an individual participating in this study, throughout this document “you(r)” = “the participant”. 
 
Thank you for your interest in our research study. Please read this consent form or ask someone to read it to you. 
If you decide to join the study, we will ask you to sign or make your mark on this form. We will offer you a copy 
to keep. We will ask you questions to see if we have explained everything clearly. You can also ask us questions 
about the study.  
 
Research is not the same as treatment or medical care. The purpose of a research study is to answer scientific 
questions. 
 
1. Summary Information 
 
Here is a summary of important information about the study: 
 
The purpose of the study is to estimate the number of people who have or have had the SARS-CoV-2 virus in 
different communities in the United States. Some people know this virus by the name “coronavirus.” It can cause 
the disease called COVID-19. There is no drug given in this study for prevention or treatment.  
 
If you choose to join, you will have one study visit either right after signing this consent form or at a later date at 
the clinic. If you are available now, the visit procedures will take place right here. You will complete a 
questionnaire, provide a blood sample and have a nasal swab collected. Some participants may be asked to also 
provide a saliva sample and additional nasal swab. [Only include saliva if your site is participating in this subset. 
Otherwise, delete.] [For participants recruited from health facilities, also include: We will also collect some 

CoVPN 5002, Version 2.0 
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information from your health records to document chronic diseases, smoking history, and history of SARS-CoV-2 
diagnosis.]  
 
Some general risks include discomfort when your blood is drawn. Nasal swabs may cause minor irritation to your 
nose, and sneezing and rarely, may cause a nosebleed. You may also feel worried or anxious while waiting for 
your SARS-CoV-2 test results.  
 
There may be no direct benefit to you for taking part in this study, but the information learned from this study 
may help researchers develop new ways to prevent and/or treat SARS-CoV-2 infection. We will provide you with 
free SARS-CoV-2 testing and direct you to resources for help if you are feeling sick or need information on how 
to avoid passing the virus on to others.  
 
Whether to take part in this study is your choice. You do not have to take part in the study and you are free to stop 
at any time. 
 
The rest of this form provides a more complete description of this study. Please read it carefully. 
 
ABOUT THE STUDY 
 
The COVID-19 Prevention Network (CoVPN) is doing a study to estimate the number of people who have or 
have had the SARS-CoV-2 virus in different communities in the United States. This study is being done to help 
determine the best places to perform future research studies that will test new drugs for treatment or prevention of 
COVID-19.  
 
Between 78,000 – 98,000 people will take part in this study at multiple places around the country. In each 
community, ~3920 will be enrolled. The researcher in charge of this study in your community is 
[Insert name of site PI] and s/he is located at [Insert CRS name]. The [sponsor] is paying for the study.  
 
2. We are doing this study to answer several questions. 
 
• 
How many people in the study communities have or have had SARS-CoV-2 or COVID-19? 
• 
What do people in the study communities know about SARS-CoV-2 or COVID-19? 
• 
How do people in the study communities feel about SARS-CoV-2 or COVID-19? 
• 
How often and in what ways are people exposed to SARS-CoV-2?   
• 
What is the general health of people in the study communities? 
 
3. There is no drug or treatment provided as part of this study. 
 
This is an observational study. We are only testing participants for SARS-CoV-2, drawing blood for additional 
lab testing related to SARS-CoV-2, and asking participants to complete a questionnaire.   
 
JOINING THE STUDY 
 
4. It is completely up to you whether or not you join the study.  
 
Take your time in deciding. If it helps, talk to people you trust such as a friends or family member. If you decide 
not to join this study, or if you discontinue before you complete the study procedures, you will not lose any 
benefits or rights you would normally have at [CRS name]. 
 
 

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5. If you want to join the study, we will screen you to see if you are eligible. 
 
Screening involves a brief questionnaire to determine: 
• 
Your age 
• 
Where you live 
• 
If you are enrolled in another SARS-CoV-2 or COVID-19 clinical trial which involves taking an 
experimental medication 
• 
If you are already enrolled in this study in another community 
 
BEING IN THE STUDY 
 
If you meet the study requirements and want to join, here is what will happen: 
 
6. You will have one study visit either immediately after signing the consent form or at a later date that is 
more convenient for you. 
 
This study includes a single study visit. It will take approximately 30 minutes to complete the study visit. (If all 
procedures cannot be completed in one visit, sample collection and the brief survey must be completed during the 
same visit within 10 days of completing this consent). The study procedures will include: 
 
• 
Collecting basic information about you, your health, your household, and possible exposure to SARS-
CoV-2 (completed by parents of participants 0-9 years old) 
• 
Completing a brief survey about your knowledge and feelings about SARS-CoV-2 (completed by parents 
of participants 0-9 years old) 
• 
Drawing blood for lab testing related to SARS-CoV-2 
o ~10 mL if you are > 6 years old or 1 ml from a fingerstick after having had unsuccessful venous 
puncture attempts  
o ~6 mL if you are 2 – 6 years old  
o ~500 uL in a microtainer tube if you are 2 months to < 2 years old  
▪ 
A heel stick is recommended for participants 2-6 months and finger stick for participants 
6 months to 2 years old  
• 
Performing nasal swab testing for SARS-CoV-2 
• 
Some participants may be asked to provide saliva and an additional nasal swab for SARS-CoV-2 testing. 
[Only include if your site is participating in this subset. Otherwise, delete.] 
• 
[For participants recruited from health facilities, also include: We will also collect some information 
from your health records related to chronic conditions, smoking history, and prior SARS-CoV-2 
diagnosis.] 
 
7. You will receive a gift card for [$X] when you complete the study visit. 
 
This amount is to compensate you for your time. You do not have to pay anything to be in this study. 
 
8. We will test your samples to see if you have or have had SARS-CoV-2 
 
We will test your samples for SARS-CoV-2 RNA. This will tell us if you have the SARS-CoV-2 virus in your 
body. You will be given a [phone number or website] to retrieve the results of these tests. We will also test for 
antibodies against SARS-CoV-2. Antibodies are the proteins your body makes to fight infections. Antibody tests 
will tell us if you have SARS-CoV-2 now or if you had it in the past. These tests are only for research purposes. 
Results from these tests will not be returned to you.    
 

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Your samples may also be used to help characterize SARS-CoV-2 viruses and the body's response to SARS-CoV-
2 infection. They may also be used to study how the virus spreads in the community, and to study other infections 
that may have an effect on COVID-19. These tests are only for research purposes. Results from these tests will 
not be returned to you.    
 
Testing will not include sequencing your full DNA.  
 
9. When samples are no longer needed for this study, the CoVPN may want to use them in other studies 
and share them with other researchers. 
 
These samples are called “extra samples”. The CoVPN will only allow your extra samples to be used in other 
studies if you agree to this. You will mark your decision at the end of this form. If you have any questions, please 
ask. 
 
Do I have to agree? No. You are free to say yes or no, or to change your mind after you sign this form. At your 
request, we will destroy all extra samples that we have. Your decision will not affect your being in this study or 
have any negative consequences here.  
 
Where are the samples stored? Extra samples are stored in a secure central place called a repository. Your 
samples will be stored in a repository in the United States. 
 
How long will the samples be stored? There is no limit on how long your extra samples will be stored. [Site: 
Revise the previous sentence to insert limits if your regulatory authority imposes them.] 
 
Will I be paid for the use of my samples? No. Also, a researcher may make a new scientific discovery or 
product based on the use of your samples. If this happens, there is no plan to share any money with you. The 
researcher is not likely to ever know who you are. 
 
Will I benefit from allowing my samples to be used in other studies? Probably not. Results from these other 
studies are not given to you, this clinic, or your doctor. They are not part of your medical record. The studies are 
only being done for research purposes. 
 
Will the CoVPN sell my samples and information? No, but the CoVPN may share your samples with other 
researchers. Once we share your samples and information, we may not be able to get them back. 
 
How do other researchers get my samples and information? When a researcher wants to use your samples 
and information, their research plan must be approved by the CoVPN. Also, the institutional review board (IRB) 
will review this plan. IRBs protect the rights and well-being of people in research. If the research plan is 
approved, the CoVPN will send your samples to the researcher’s location.  
 
What information is shared with the CoVPN or other researchers? The samples and information will be 
labeled with a code number. The key to the code will stay at the CRS. It will not be shared with the CoVPN or 
other researchers. Your name will not be part of the information. However, some information that we share may 
be personal, such as your race, ethnicity, sex, health information from the study, and lab test results.  
 
What kind of studies might be done with my extra samples and information? The studies will be related to 
SARS-CoV-2, COVID-19, vaccines, antibodies, the immune system (your body’s defense system) and other 
diseases. Testing will not include sequencing your full DNA. 
 
 
 

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Who will have access to my information in studies using my extra samples? People who may see your 
information are: 
 
• 
Researchers who use your extra samples and information for other research 
• 
Government agencies that fund or monitor the research using your extra samples and information 
• 
Any regulatory agency that reviews clinical trials 
• 
An Institutional Review Board 
• 
The people who work with the researcher  
 
All of these people will do their best to protect your information. The results of any new studies that use your 
extra samples and information may be published. No publication will use your name or identify you personally. 
 
10. We will do our best to protect your private information. 
 
[Sites should verify there are no HIPAA conflicts with this section.] 
Your study records and samples will be kept in a secure location. We will label all of your samples and most of 
your records with a code number, not your name or other personal information. However, it is possible to identify 
you, if necessary. We will not share your name with the lab that does the tests on your samples, or with anyone 
else who does not need to know your name. 
 
Clinic staff will have access to your study records. Your records may also be reviewed by groups who watch over 
this study to see that we are protecting your rights, keeping you safe, and following the study plan. These groups 
include: 
 
• 
The US National Institutes of Health and its study monitors, 
• 
Any regulatory agency that reviews clinical trials, 
• 
[Insert name of sIRB], 
• 
[Insert name of local and/or national regulatory authority as appropriate], 
• 
The CoVPN and people who work for them,  
• 
The US Office for Human Research Protections. 
 
All reviewers will take steps to keep your records private. 
 
We cannot guarantee absolute privacy. If you are found to have SARS-CoV-2 or another medical condition that 
we are required to report by law, then some of your information may be shared. At this clinic, we have to report 
the following information:  
 
[Site: Include any public health or legal reporting requirements. Bulleted examples should include all 
appropriate cases (reportable communicable disease, risk of harm to self or others, etc.). If your site does not 
have public health or legal reporting requirements, you may delete the last sentence in the paragraph above, 
along with the bullets below.] 
• 
[Item 1] 
• 
[Item 2] 
• 
[Item 3] 
 
We have a Certificate of Confidentiality from the US government, to help protect your privacy. With the 
certificate, we do not have to release information about you to someone who is not connected to the study, such as 
the courts or police. Sometimes we can’t use the certificate. Since the US government funds this research, we 
cannot withhold information from it. Also, you can still release information about yourself and your study 
participation to others. 

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The results of this study may be published. No publication will use your name or identify you personally. 
We may share information from the study with other researchers. We will not share your name or information that 
can identify you. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results. You can search this 
website at any time. 
 
11. If you are infected with SARS-CoV-2. 
 
We will direct you to resources you can access if you are feeling sick and information on how to avoid passing 
SARS-CoV-2 to others.  
 
OTHER RISKS 
 
12. There are other risks to being in this study. 
 
Risks of giving blood:  
Taking blood samples may cause some pain, bruise your arm, or make you feel lightheaded. In rare cases you 
may faint. There is also a slight chance of infection when blood is drawn.  
 
SARS-CoV-2 testing 
Nasal swabs may cause minor irritation to your nose, and sneezing and rarely, may cause a nosebleed. 
 
You may be nervous while you are waiting for your SARS-COV-2 test result. 
 
Completing the questionnaire 
You may become embarrassed, worried, or anxious when completing the survey. 
 
Risk of exposure to SARS-CoV-2 from other people: 
Participating in this research study may increase your risk of exposure to SARS-CoV-2 from other people.  
However, your research site will do everything they can to make this risk as small as possible by [include details 
of how staff will protect participants from exposure]. 
 
Risks of disclosure of your personal information: 
We will take several steps to protect your personal information. Although the risk is very low, it is possible that 
your personal information could be given to someone who should not have it. If that happened, you could face 
discrimination, stress, and embarrassment. We can tell you more about how we will protect your personal 
information if you would like it.  
 
BENEFITS 
 
13. The study may not benefit you. 
 
There may be no direct benefits to participating in this study. However, being in the study might still help you in 
some ways. You will receive the results of your SARS-COV-2 RNA testing. The counseling that you get as part 
of the study may help you avoid getting SARS-CoV-2 or help you avoid passing it to others if you do have it or 
get it.  
 
This study may also help in the search for ways to prevent or treat COVID-19.  
 

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LEAVING THE STUDY 
 
14. Tell us if you no longer want to be included in the study.  
 
There will only be one study visit that will take place today. You are free to end the visit or withdraw your 
consent at any time and for any reason. Your care at [CRS name] and your legal rights will not be affected.  
 
If you choose to leave the study at a later date, the researchers may keep and analyze the data already collected, as 
long as it relates to the study described in this consent form.  
 
15. You may be removed from the study 
 
You may be withdrawn from the study in order to protect their safety and/or if you are unwilling or unable to 
comply with required study procedures. 
 
INJURIES 
 
16. If you get sick or injured because of the study, contact us immediately. 
 
It is unlikely that you will be injured as a result of study participation. If you are injured, the [CRS name] staff 
will give you immediate necessary treatment for your injuries. You [will/will not] have to pay for this treatment. 
You will be told where you can get additional treatment for your injuries. [Must include the following:] There is 
no program to pay money or give other forms of compensation for such injuries either through this institution or 
the US NIH. You do not give up any legal rights by signing this consent form. 
 
QUESTIONS  
 
17. Contact us at any time if you have questions or problems. 
 
If you have questions about this study, contact [contact information] 
 
If you have any symptoms that you think may be related to this study, contact [contact information] 
 
If you have questions about your rights as a research participant, you should contact [insert name or title of 
person on the IRB or other organization appropriate for the site] at [contact information]. 
 
If you want to be excluded from the study after you’ve completed your study visit, contact [contact information]. 
 
 

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YOUR PERMISSIONS AND SIGNATURE  
[NOTE TO SITES: Delete this section if using a separate consent for use of samples and information in other 
studies] 
 
1. Permission to use extra samples. 
 
In Section 9 of this form, we told you about possible other uses of your extra samples and information, outside 
this study. Please choose only one of the options below and write your initials or make your mark in the box next 
to it. Whatever you choose, the CoVPN will keep track of your decision about how your samples and information 
can be used. You can change your mind after signing this form. 
 
 
 
 
I allow my extra samples and information to be used for other studies related to SARS-CoV-2 
prevention, the immune system, and other diseases.  
OR 
 
 
I do not allow my extra samples to be used in any other studies.  
 
 
2. What does your signature on this consent form mean? 
 
• 
You understand the information given to you in this consent form. 
• 
You accept the provisions in the form [or, on behalf of the participant]. 
• 
You have had your questions answered and know that you can ask more. 
• 
You agree to participate [or permit the participant to join the study]. 
 
You will not give up any of your [or the participant’s] legal rights by signing this consent form. 
CONSENT TO TAKE PART IN THIS STUDY 
 
In consideration of all the above, I give my consent [for my child/the participant] to participate in this research 
study.  
 
Note to site: Next 3 lines are only for legally authorized representatives, parents, or guardians, giving consent for 
someone with cognitive incapacity or for a minor. 
 
LEGALLY AUTHORIZED REPRESENTATIVE (LAR)/PARENT/GUARDIAN INFORMED CONSENT 
 
 
___________________________ 
___________________________ 
___________ 
____________ 
LAR/parent/guardian name (print) 
LAR/parent/guardian signature 
Date 
Time 
 
 
 
Relationship to participant: ____________________________ 
 
 
 

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___________________________ 
___________________________ 
___________ 
____________ 
Participant’s name (print) 
Participant’s signature or mark 
Date 
Time 
 
 
 
___________________________ 
___________________________ 
___________ 
____________ 
Staff conducting consent 
discussion (print) 
Staff signature 
Date 
Time 
 
 
For participants who are unable to read or write, a witness should complete the signature block below: 
 
 
___________________________ 
___________________________ 
___________ 
____________ 
Witness’s name* (print) 
Witness’s signature 
Date 
Time 
 
*Witness is impartial and was present for the entire discussion of this consent form. 

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APPENDIX III: SAMPLE ASSENT FORM 
 
CoVPN 5002 
 
 
SARS-COV-2 PREVALENCE STUDY  
 
Version 2.0 
26 May 2021 
DAIDS-ES ID: 38749 
 
Sponsored by: United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National 
Institutes of Health (NIH) 
 
Site: 
Principal Investigator: 
Phone: 
 
Population: Minors, ages 7- 13 years, enrolling from community venues  
 
WHAT IS A RESEARCH STUDY? 
Research studies help us learn new things.  First, we ask a question.  Then we try to find the answer.   
 
This paper talks about our research and the choice that you have to take part in it.  We want you to ask us any 
questions that you have.  You can ask questions any time.  
 
IMPORTANT THINGS TO KNOW… 
• 
You get to decide if you want to take part 
• 
You can say ‘No’ or you can say ‘Yes’ 
• 
No one will be upset if you say ‘No’ 
• 
If you say ‘Yes’, you can always say ‘No’ later 
• 
You can say ‘No’ at any time 
 
WHY ARE WE DOING THIS RESEARCH? 
We are doing this research to find out how many people in your community have or have had the SARS-CoV-2 
coronavirus or COVID-19. 
 
WHAT WOULD HAPPEN IF I JOIN THIS RESEARCH? 
If you decide to be in the research, we would ask you to do the following: 
• 
Questionnaire: We would ask you some questions and mark your answers on our tablet. Your parent or 
guardian can help you answer those questions.   
• 
Blood draws: We would collect a small amount of blood, about 2 teaspoons, with a needle.  
• 
Nasal Swab): We will use a swab to collect some fluid from your nose. 
• 
Saliva collection: You may be asked to provide some saliva. and an additional nasal swab. [Only 
include if your site is participating in this subset. Otherwise, delete.] 
 
COULD BAD THINGS HAPPEN IF I JOIN THIS RESEARCH? 
 
Drawing blood may cause some pain, bruise your arm, or make you a little dizzy. In rare cases you may faint. 
There is also a slight chance of infection after blood is drawn.  

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Nasal swabs may cause minor irritation to your nose, and sneezing and rarely, may cause a nosebleed. 
 
You may be nervous while you are waiting for your SARS-COV-2 test result. 
 
You may become embarrassed, worried, or nervous when completing the questionnaire. 
 
You may come into contact with someone with SARS-CoV-2 but we will do everything we can to protect you 
like [include details of how staff will protect participants from exposure]. 
 
We will do everything we can to protect your privacy but there is a small chance that your information could be 
given to someone who should not have it. If that happened, you could face discrimination, stress, and 
embarrassment. We can tell you more about how your information will be protected, if you wish.  
 
 
COULD THE RESEARCH HELP ME? 
There may be no direct benefits to participating in this study. However, being in the study might still help you in 
some ways. You will receive the results of your SARS-COV-2 RNA testing. The counseling that you get as part 
of the study may help you avoid getting SARS-CoV-2 or help you avoid passing it to others if you do have it or 
get it.  
 
This study may also help in the search for ways to prevent or treat COVID-19.  
 
WHAT ELSE SHOULD I KNOW ABOUT THIS RESEARCH? 
If you don’t want to be in the study, you don’t have to be. 
 
It is also OK to say yes and change your mind later.  You can stop being in the study at any time.  If you want to 
stop, please tell us. 
 
To thank you for being in the study, we would give you [$XX]. We will hand this money to your parent/guardian 
to hold for you.  
 
You can ask us questions any time.     
 
IS THERE ANYTHING ELSE? 
If you want to be in the study after we talk, please write your name below.  We will write our name too.  This 
shows we talked about the research and that you want to take part. 
 
 
 
Printed Name of Participant _______________________________________________ 
(To be written by child/adolescent) 

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Signature of Participant _______________________________________________ 
(N/A for children who do not have a signature) 
 
 
Printed Name of Researcher ___________________________________________________ 
 
 
Signature of Researcher _______________________________________________________ 
 
 
___________                                                              _____________ 
Date        
                                                             
Time       
 

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APPENDIX IV: SAMPLE VERBAL PRE-SCREENING SCRIPT 
 
CoVPN 5002 
 
SARS-COV-2 PREVALENCE STUDY 
 
Version 2.0 
  
26 May 2021 
DAIDS-ES ID: 38749 
 
Sponsored by: United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National 
Institutes of Health (NIH) 
 
Site: 
Principal Investigator: 
Phone: 
 
NOTE TO SITE: This script should be adapted to accommodate younger participants.  
 
  
 
Participant Information Sheet (to be summarized verbally or offered on paper to all people who screen) 
 
Site [insert name and address] 
Principal Investigator: [insert name] 
Phone: [insert number] 
 
Purpose: The purpose of this study is to estimate the number of people who have or have had SARS-COV-2 
virus in different communities in the United States.  
 
Commitment: If you choose to join, you will have one study visit either right after signing this consent form or at 
a later date at the clinic. If you are available now, the visit procedures will take place right here. You will 
complete a questionnaire, provide a blood sample and have a nasal swab collected. Some participants may be 
asked to also provide a saliva samples and additional nasal swab. [Only include saliva if your site is participating 
in this subset. Otherwise, delete.] [For participants recruited from health facilities, also include: We will also 
collect some information from your health records to document chronic diseases, smoking history, and history of 
SARS-CoV-2 diagnosis.]  
 
Benefits: There may be no direct benefit to you for taking part in this study, but the information learned from this 
study may help researchers develop new ways to prevent and/or treat SARS-CoV-2 infection. We will provide 
Interviewer Script: 
Hi, my name is [interviewer’s name] and I work at [name of institution]. We are 
conducting a research study in this community and XX other communities in the 
United States to estimate the number of people who have or have had the SARS-COV-
2 virus. Some people know this virus by the name “coronavirus.” It can cause the 
disease called COVID-19.  It can cause a disease called COVID-19. Please note: You 
are a volunteer and can decide not 
to take part or can quit at any time. 
 

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you with free SARS-CoV-2 testing and direct you to resources for help if you are feeling sick or need information 
on how to avoid passing the virus on to others. 
 
For more information contact: [insert name and number] 
 
The study will take place at: [insert site address] 
 
 
 
 

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APPENDIX V: SUMMARY OF CURRENT SARS-COV-2 SURVEILLANCE STUDIES 
 
Study Title and Identifier 
Study Description and Objective 
Study Design 
Location 
Surveillance of Individuals 
Following SARS-CoV-2 
Exposure (NCT04383444) 
To better understand how long it takes an adult person to 
develop (or not develop) an infection with the SARS-
CoV-2 virus after they have had contact with a person 
who has a confirmed infection. 
Prospective longitudinal cohort 
study with 21-day follow-up 
Bethesda, MD 
COVID-19: Human 
Epidemiology and 
Response to SARS-CoV-2 
(HEROS) (NCT04375761) 
To: 1) determine the prevalence of SARS-CoV-2 carrier 
status over time in children and parents; 2) determine 
prevalence of antibody development over time in 
children and parents; 3) compare carrier status and 
antibody development for children with asthma and/or 
other atopic conditions versus children without asthma 
and/or other atopic conditions; and 4) Investigate the 
presence of SARS-CoV-2 exposure in historical samples 
from enrolled participants.  
Active surveillance study with 6-
month follow-up of children and 
their parents previously enrolled 
in a cohort study  
Aurora, CO 
Washington, D.C. 
Boston, MA 
Detroit, MI 
Saint Louis, MO 
New York, New York 
Cincinnati, OH 
Nashville, TN 
Dallas, TX 
Madison, WI 
Registry to Study Factors 
that may Impact COVID-19 
Occurrence and Severity 
(NCT04368065) 
To better understand risk factors, symptoms, and 
treatments for COVID-19 illness in adults with potential 
exposure. 
Observation, direct-to-participant, 
web-based, longitudinal study 
with 3-month follow-up of adults 
Outreach will target 
regions with high known 
prevalence of COVID-
19 infection; however 
registration is open to all  
Seroprevalence of SARS-
CoV-2 Antibodies in 
Previously Undiagnosed 
Healthcare Workers 
(NCT04383587) 
To identify healthcare workers with SARS-CoV-2 
antibodies who have not been previously diagnosed and 
are presumed COVID-19 negative, then determine the 
level of immunity in this population which could inform 
further decisions about widespread antibody testing in a 
healthcare worker population. 
Cross-sectional 
Mayo Clinic in 
Jacksonville, FL 
Longitudinal COVID-19 
Cohort Study 
(NCT04393155) 
To assess whether survivors from severe COVID-19 
experience persistent functional impairments and to 
investigate the biologic mechanisms underlying these 
functional impairments.   
Longitudinal study with 1-year of 
follow-up of hospitalized 
COVID-19 patients 
University of Vermont 
and Johns Hopkins 
University 

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Study Title and Identifier 
Study Description and Objective 
Study Design 
Location 
SARS-CoV-2 Pandemic 
Serosurvey and Blood 
Sampling (NCT04334954) 
To find the number of people with detectable antibodies 
to SARS-CoV-2 from a sampling of adults who have no 
known exposure or clinical illness. 
Cross-sectional 
University of Alabama, 
National Institutes of 
Health Clinical Center, 
University of Pittsburgh