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NCT05042232 Clinical Trial

A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

Official title:
Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed With COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05042232
Other study ID # EW-US-4010-0003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 19, 2021
Est. completion date June 14, 2022

Study information
Verified date June 2022
Source Everly Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to identify and describe patient behaviors and clinical outcomes among patients who have tested positive for mild to moderate COVID-19.

Description:

This virtual observational cohort study will describe patient behaviors and clinical outcomes of subjects who tested positive for COVID-19. Among those with positive tests, predictors of time to recovery, post-COVID function and outcomes will be identified. Individuals who test negative and positive for SARS-CoV-2 will be enrolled in the study.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date June 14, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >=18 years - Individuals with a valid diagnostic COVID-19 test result Exclusion Criteria: - Unable or unwilling to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SARS-CoV-2 Positive
Participants who have tested positive for SARS-CoV-2, both with and without symptoms
• SARS-CoV-2 Negative
Participants who have tested negative for SARS-CoV-2

Locations
Country Name City State
United States Everlywell, Inc Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Everly Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19 Up to 12 months
Secondary To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement Up to 12 months
Secondary To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing Up to 12 months
Secondary To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity Up to 12 months
Secondary To describe the feasibility of COVID-19 home testing Up to 12 months
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