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

Everly Health1 site in 1 country239 target enrollmentApril 19, 2021

ConditionsSARS-CoV-2 Acute Respiratory Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: SARS-CoV-2 Acute Respiratory Disease
Sponsor: Everly Health
Enrollment: 239
Locations: 1
Primary Endpoint: To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 19, 2021

End Date

June 14, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Everly Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>=18 years
•Individuals with a valid diagnostic COVID-19 test result

Exclusion Criteria

•Unable or unwilling to provide informed consent

Outcomes

Primary Outcomes

To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19

Time Frame: Up to 12 months

Secondary Outcomes

To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement(Up to 12 months)
To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing(Up to 12 months)
To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity(Up to 12 months)
To describe the feasibility of COVID-19 home testing(Up to 12 months)