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COVID-19NCT04368065

COVID-19 Active Research Experience (CARE)

An observational study of COVID-19, run by IQVIA Pty Ltd at 2 sites in 2 countries.

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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
How many people
35,278 participants
Where
2 sitesin 2 countries
Study dates
2 Apr 2020to 23 Feb 2023
How long will I take part?
12 Months
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
  • Adult, Older adult

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.

Who may be able to join

  • 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:
Show all 9Show fewer
  • Have COVID-19 or COVID-19 like symptoms
  • Received a COVID-19 vaccine
  • Potential exposure to COVID-19

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • IQVIA

    Cambridge, Massachusetts, 02139

Other trials in United States

United Kingdom1 site

  • IQVIA

    London

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
COVID-19
Medical subject headings
COVID-19

What is being measured

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

  1. COVID-19 symptom occurrence and severity

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

    Measured: 12 months

  2. COVID-19 treatments

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

    Measured: 12 months

  3. COVID-19 risk factors

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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. Occurrence of medically attended events after vaccination

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

    Measured: 1 month

Timeline

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

  1. First posted29 Apr 2020
  2. Study start2 Apr 2020
  3. Primary completion23 Feb 2023
  4. Study completion23 Feb 2023

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
35,278 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368065
Sponsor's protocol ID
IQVIA_COVIDREGISTRY_2020
Status last verified
Mar 2023
First submitted
28 Apr 2020
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38412008

  • 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.

    PubMed 37336535

  • 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.

    PubMed 36148919

  • 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.

    PubMed 36090603

  • 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.

    PubMed 35177299

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by IQVIA Pty Ltd at 2 sites in 2 countries.

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 9 inclusion and 2 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, United Kingdom. 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?

COVID-19 symptom occurrence and severity (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT04368065, which also lists 5 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 28 Mar 2023.

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