COVID-19 Active Research Experience (CARE)

Completed

• Conditions: COVID-19

• Registration Number: NCT04368065
• Lead Sponsor: Iqvia Pty Ltd

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.

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 Timeline

• Study Start: 2020-04-02
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35278

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 symptom occurrence and severity	12 months	Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey
Occurrence of medically attended events after vaccination	1 month	Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine
COVID-19 risk factors	12 months	Assess potential role of comorbidities and concomitant medications on COVID-19 occurrence and severity
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
COVID-19 treatments	12 months	Prescription treatments for COVID-19 as reported by participants in the survey

Trial Locations

Locations (1)

IQVIA; 🇬🇧 London, United Kingdom