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Clinical Trials/NCT05042232
NCT05042232CompletedNot Applicable

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

Everly Health1 site in 1 country239 target enrollmentStarted: April 19, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
239
Locations
1
Primary Endpoint
To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor
Everly Health
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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