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Covid19NCT05548803

COVID-19 Citizen Science Expansion Project

An observational study of Covid19, run by University of California, San Francisco at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19
How many people
52,351 participants
Where
9 sitesUnited States
Study dates
18 Mar 2020to 1 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 1. Unable or unwilling to provide informed consent

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Baylor Scott and White Health

    Dallas, Texas, 95246

  • Advocate Aurora Health

    Downers Grove, Illinois, 60515

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • NYC Health + Hospitals

    New York, New York, 10004

  • New York University

    New York, New York, 10016

  • Sutter Health

    Sacramento, California, 95833

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California, San Francisco

    San Francisco, California, 94158

  • Albert Einstein College of Medicine

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Comparing Patient-reported Impact of COVID-19 Shelter-in-place Policies and Access to Containment and Mitigation Strategies, Overall and in Vulnerable Populations

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.

Read the detailed description

Shelter-in-place orders, social distancing, and mandatory closure of non-essential businesses across the country have suppressed transmission of SARS-CoV-2 and limited direct health impact of the COVID-19 Pandemic. These policies, however, exact an enormous societal cost and cannot be maintained indefinitely. When and how to lift restrictions represents the defining challenge of our time for local, state and national leaders, and requires excruciating decisions that balance lives lost from coronavirus infection against economic, social and indirect health effects of restrictive policy. To understand the impact of these decisions, we must hear from patients. We propose to recruit a large population-based sample of PCORnet patients into our digital cohort of "COVID-19 Citizen Scientists," gather patient-reported outcomes with linked electronic health record (EHR), and analyze it to answer the following critical research questions (RQs):

RQ1: What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients? The natural experiment that occurs as state governors and local county health departments across the US differentially lift and/or reinstate shelter-in-place policies, and that is ongoing today as the US considers reopening fully (despite threats from new coronavirus variants), represents an analytic opportunity to estimate and compare benefits and harms of different policies, both overall and for vulnerable subsets of the population. To leverage this opportunity, we will collect a detailed record of county- (and state-) level COVID-19-related policies, including shelter-in-place (aka containment \& closure), economic response and public health policies, starting at the beginning of the Pandemic in March 2020 and continuing through the end of the year into 2021. We have selected 119 counties for data collection where we have the most patient-reported survey responses through 2020, and where we expect to enroll many new participants through Fall 2021. We will use these data to analyze the impact on patient-reported outcomes, and then make them available to other investigators.

RQ2: What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to COVID-19 vaccination (overall and among previously hesitant persons), testing, healthcare, information, and contact tracing, overall and in vulnerable populations? Timely access to containment and mitigation strategies were (and will continue to be) critical to quickly detect and slow transmission of coronavirus and future pandemics in communities, and to effectively care for patients who become infected. Unlike shelter-in-place policies that are highly publicized, containment and mitigation strategies are about resource allocation and operational effectiveness. Decision-making may be hidden, but we can measure the effectiveness of these strategies by asking patients. For example, we can assess reasons for vaccination among participants that were previously hesitant, delays in coronavirus testing after patients develop symptoms using our daily symptom survey data to provide the denominator (all symptomatic patients) and the anchor time point (time of symptom onset); and weekly surveys will assess access to critical information (e.g., "Do you know how to get a COVID-19 test?") and contact tracing after testing positive.

Conditions
Covid19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Over the course of the pandemic, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start18 Mar 2020
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
52,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05548803
Sponsor's protocol ID
20203090
Status last verified
Jul 2026
First submitted
19 Sep 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cozen AE, Hamad R, Park S, Marcus GM, Olgin JE, Faulkner Modrow M, Chiang A, Brandner M, Orozco JH, Azar K, Sudat SEK, Isasi CR, Williams N, Ozluk P, Kitzman H, Knight SJ, Sanchez-Birkhead A, Kornak J, Carton T, Pletcher M. Associations between local COVID-19 policies and anxiety in the USA: a longitudinal digital cohort study. BMJ Public Health. 2025 Jan 16;3(1):e001135. doi: 10.1136/bmjph-2024-001135. eCollection 2025.

    PubMed 40017931

  • Cozen AE, Carton T, Hamad R, Kornak J, Faulkner Modrow M, Peyser ND, Park S, Orozco JH, Brandner M, O'Brien EC, Djibo DA, McMahill-Walraven CN, Isasi CR, Beatty AL, Olgin JE, Marcus GM, Pletcher MJ. Factors associated with anxiety during the first two years of the COVID-19 pandemic in the United States: An analysis of the COVID-19 Citizen Science study. PLoS One. 2024 Feb 6;19(2):e0297922. doi: 10.1371/journal.pone.0297922. eCollection 2024.

    PubMed 38319951

  • Crull E, O'Brien EC, Antiperovitch P, Asfaw K, Beatty AL, Djibo DA, Kaul AF, Kornak J, Marcus GM, Modrow MF, Olgin JE, Orozco J, Park S, Peyser N, Pletcher MJ, Carton TW. Concordance Between Survey and Electronic Health Record Data in the COVID-19 Citizen Science Study: Retrospective Cohort Analysis. JMIR Form Res. 2025 Jul 28;9:e58097. doi: 10.2196/58097.

    PubMed 40720880

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by University of California, San Francisco at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GAD-7 anxiety score (time frame: Over the course of the pandemic, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05548803, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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COVID-19 Citizen Science Expansion Project | AzTrials