COVID-19 Active Research Experience (CARE)

March 27, 2023 updated by: IQVIA Pty Ltd

Registry to Study Factors That May Impact COVID-19 Occurrence and Severity

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness. Upon consent and enrollment, participants will complete an initial baseline survey reporting their demographics, relevant medical history, testing, vaccination, symptoms, use of prescription medications as well as use of supplements and other factors. The study follow-up period is 12 months. During the first month of follow-up participants will be invited to complete a symptom diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-pharmaceutical interventions as well as healthcare encounters. Reporting will then reduce to monthly for Month 2 through 12.

Study Type

Observational

Enrollment (Actual)

35278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 symptom occurrence and severity
Time Frame: 12 months
Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey
12 months
COVID-19 treatments
Time Frame: 12 months
Prescription treatments for COVID-19 as reported by participants in the survey
12 months
COVID-19 risk factors
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 1 month
Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IQVIA Pty Ltd

Investigators

  • Principal Investigator: Nancy Dreyer, PhD, MPH, IQVIA Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Actual)

February 23, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IQVIA_COVIDREGISTRY_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available during conduct of the study and two years following study completion.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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