COVID-19 Active Research Experience (CARE)

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368065
• Other study ID #: IQVIA_COVIDREGISTRY_2020
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: February 23, 2023

Study information

• Verified date: March 2023
• Source: Iqvia Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 effectiveness.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35278
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United Kingdom	IQVIA	London
United States	IQVIA	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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

External Links

•   Study Website