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Completed

NCT Number: NCT04368065

COVID-19 Active Research Experience (CARE)

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IQVIA, London, United Kingdom

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. COVID-19 treatments

    Time frame: 12 months

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

  3. COVID-19 risk factors

    Time frame: 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

    Time frame: 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

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

IQVIA Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2020
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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