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COVID-19 Active Research Experience (CARE)

Sponsor
Iqvia Pty Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04368065
Collaborator
(none)
100,000
Enrollment
2
Locations
37.9
Anticipated Duration (Months)
50000
Patients Per Site
1317.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Registry to Study Factors That May Impact COVID-19 Occurrence and Severity
    Actual Study Start Date :
    Apr 2, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. COVID-19 symptom occurrence and severity [12 months]

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

    2. COVID-19 treatments [12 months]

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

    3. COVID-19 risk factors [12 months]

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

    4. Occurrence and severity of COVID-19 infection after vaccination [12 months]

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

    5. Occurrence of medically attended events after vaccination [1 month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IQVIA Cambridge Massachusetts United States 02139
    2 IQVIA London United Kingdom

    Sponsors and Collaborators

    • Iqvia Pty Ltd

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Iqvia Pty Ltd
    ClinicalTrials.gov Identifier:
    NCT04368065
    Other Study ID Numbers:
    • IQVIA_COVIDREGISTRY_2020
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 12, 2021