NCT05548803

Brief Summary

COVID-19 Citizen Science (CCS), launched in March 2020, supports collaborative research on symptoms, risk factors, surveillance, biomarkers and testing for COVID-19 using the Eureka Research Platform. CCS maintains IRB approval with UCSF's IRB (UCSF IRB# 17-21879). This CCS Expansion Project, which is funded jointly by the National Institutes of Health (NIH), the Patient-Centered Outcomes Research Institute (PCORI), and the Bill and Melinda Gates Foundation, will invite patients at health systems across the US to contribute their health records data and then join the established CCS study, allows for linked analysis of CCS data and health records data, and provides the scientific rationale and plan for the project.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54,689

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

3.8 years

First QC Date

September 19, 2022

Last Update Submit

October 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • GAD-7 anxiety score

    Anxiety is measured in monthly surveys using the seven-item General Anxiety Disorder-7 (GAD-7) questionnaire. Responses to each item in the GAD-7 are scored as integer values between 0-3 according to the frequency of symptoms during the preceding two weeks ("Not at all", "Several days", "More than half the days", or "Nearly every day"). The sum of all seven items produces a combined score between 0-21, where scores ≥ 10 are considered indicative of moderate to severe anxiety disorders

    Over the course of the pandemic, up to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our goal will be to recruit a large sample of participants that is representative of the US population. In particular, we wish to make inferences about Hispanic/LatinX and African- American/Black subsets of the US population, who appear to be especially vulnerable to both direct (infection-related) and indirect impact of the Pandemic.

You may qualify if:

  • Age ≥ 18 years
  • Has the capacity to read and comprehend English
  • Has internet access and a device (computer, tablet, laptop, etc.) that can access it

You may not qualify if:

  • \. Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sutter Health

Sacramento, California, 95833, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Advocate Aurora Health

Downers Grove, Illinois, 60515, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

NYC Health + Hospitals

New York, New York, 10004, United States

Location

New York University

New York, New York, 10016, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Baylor Scott and White Health

Dallas, Texas, 95246, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark Pletcher, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 21, 2022

Study Start

November 24, 2020

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations