Clinical trial NCT04658121: SARS-CoV-2/COVID-19 Prevalence Study
Official title: SARS-CoV-2 Prevalence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: COVID-19 Prevention Network
Sponsor class: NETWORK
First posted: 2020-12-08
Enrollment: 26741
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults residing in nursing homes or attending outpatient healthcare facilities in neighborhoods of selected research sites. Adults and children (\>2 month of age) in neighborhoods of selected research sites.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Adults residing in senior living facilities or attending outpatient healthcare facilities:

* At least 18 years of age
* Willing and able to provide informed consent or consent has been provided by legal representative (for those with mental incapacity in senior living facilities)
* Recruited from a selected facility

Adults and children from select neighborhoods of research site communities:

* Adults and children \> 2 months of age
* For individuals \< 18 years old, a guardian must be present (in person or by phone for those 15 - 17 years old)
* Willing and able to provide consent (or assent for individuals 7-17 years old, parent/guardian will provide consent for all minors)
* Recruited from a selected venue

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

Primary outcomes:
measure: To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites
timeFrame: Baseline
Secondary outcomes:
measure: To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing
timeFrame: Baseline
measure: To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19
timeFrame: Baseline
measure: To estimate seroprevalence of SARS-CoV-2
timeFrame: Baseline
measure: To assess association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence, with particular interest in racial and ethnic health disparities.
timeFrame: Baseline
measure: To estimate potential size of populations for referral to COVID-19 prevention and treatment studies
timeFrame: Baseline
measure: To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire
timeFrame: Baseline
measure: To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado CRS
state: Colorado
city: Miami
country: United States
facility: U of Miami, IDRU at Jackson Memorial Hospital CRS
state: Florida
city: Atlanta
country: United States
facility: The Ponce de Leon Center CRS
state: Georgia
city: Chicago
country: United States
facility: UIC Project Wish CRS
state: Illinois
city: New Orleans
country: United States
facility: New Orleans Adolescent Trials Unit CRS
state: Louisiana
city: Baltimore
country: United States
facility: John's Hopkins CRS
state: Maryland
city: Newark
country: United States
facility: New Jersey Medical School CRS
state: New Jersey
city: New York
country: United States
facility: Harlem Prevention
state: New York
city: New York
country: United States
facility: Physicians & Surgeons CRS
state: New York
city: New York
country: United States
facility: Bronx Prevention Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati CRS
state: Ohio
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Ponce
country: Puerto Rico
facility: St. Louis University VTEU-CAIMED-PHSU
Study officials:
affiliation: Departments of Epidemiology and Medicine, Columbia University
name: Jessica Justman, MD
role: STUDY_CHAIR
References: