NCT04368065

Brief Summary

COVID-19 Active Research Experience (CARE) is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness or who were vaccinated against COVID-19 to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
35,278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
2 countries

2 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

April 2, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

April 28, 2020

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • COVID-19 symptom occurrence and severity

    Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey

    12 months

  • COVID-19 treatments

    Prescription treatments for COVID-19 as reported by participants in the survey

    12 months

  • COVID-19 risk factors

    Assess potential role of comorbidities and concomitant medications on COVID-19 occurrence and severity

    12 months

  • Occurrence and severity of COVID-19 infection after vaccination

    Occurrence and severity of COVID-19 infection as reported by participants after SARS-CoV-2 vaccine

    12 months

  • Occurrence of medically attended events after vaccination

    Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine

    1 month

Eligibility Criteria

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

Adults living in the US or UK who have COVID-19 or COVID-19 like symptoms, were vaccinated against COVID-19, or were exposed to COVID-19.

You may qualify if:

  • Adult (18 years or older)
  • Currently living in the US or UK
  • Have regular access to a computer, smartphone or tablet and sufficient internet to support registry demands (note: this registry is designed to operate well even in regions with low bandwidth)
  • Willing and able to provide informed consent
  • Willing and able to follow the procedures of the study
  • Participants must also meet at least one of the following conditions:
  • Have COVID-19 or COVID-19 like symptoms
  • Received a COVID-19 vaccine
  • Potential exposure to COVID-19

You may not qualify if:

  • Unable to provide informed consent
  • Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IQVIA

Cambridge, Massachusetts, 02139, United States

Location

IQVIA

London, United Kingdom

Location

Related Publications (5)

  • Dreyer NA, Knuth KB, Xie Y, Reynolds MW, Mack CD. COVID-19 Vaccination Reactions and Risk of Breakthrough Infections Among People With Diabetes: Cohort Study Derived From Community Reporters. JMIR Diabetes. 2024 Feb 27;9:e45536. doi: 10.2196/45536.

  • Largent J, Xie Y, Knuth KB, Toovey S, Reynolds MW, Brinkley E, Mack CD, Dreyer NA. Cognitive and other neuropsychiatric symptoms in COVID-19: analysis of person-generated longitudinal health data from a community-based registry. BMJ Open. 2023 Jun 19;13(6):e069118. doi: 10.1136/bmjopen-2022-069118.

  • Reynolds MW, Secora A, Joules A, Albert L, Brinkley E, Kwon T, Mack C, Toovey S, Dreyer NA. Evaluating real-world COVID-19 vaccine effectiveness using a test-negative case-control design. J Comp Eff Res. 2022 Nov;11(16):1161-1172. doi: 10.2217/cer-2022-0069. Epub 2022 Sep 23.

  • Reynolds MW, Xie Y, Knuth KB, Mack CD, Brinkley E, Toovey S, Dreyer NA. COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness. Infect Drug Resist. 2022 Sep 3;15:5167-5182. doi: 10.2147/IDR.S373183. eCollection 2022.

  • Dreyer N, Reynolds MW, Albert L, Brinkley E, Kwon T, Mack C, Toovey S. How frequent are acute reactions to COVID-19 vaccination and who is at risk? Vaccine. 2022 Mar 15;40(12):1904-1912. doi: 10.1016/j.vaccine.2021.12.072. Epub 2022 Feb 9.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nancy Dreyer, PhD, MPH

    Iqvia Pty Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 29, 2020

Study Start

April 2, 2020

Primary Completion

February 23, 2023

Study Completion

February 23, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

It is anticipated that external researchers may want to leverage these data for public health and life sciences research. The intent is to provide limited data access to qualified researchers for research that has gone through a review process.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available during conduct of the study and two years following study completion.
Access Criteria
Qualified researchers that have undergone a review process may submit requests to the IQVIA Registry Data Governance Committee (DGC) requesting approval and access for specific research purposes.

Locations