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OpenTrials
Completed

NCT Number: NCT05042232

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

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.

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Key information

Conditions

SARS-CoV-2 Acute Respiratory Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Everlywell, Inc

Austin, Texas, 78703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable or unwilling to provide informed consent

Treatment and study plan

SARS-CoV-2 Positive

Other

Participants who have tested positive for SARS-CoV-2, both with and without symptoms

SARS-CoV-2 Negative

Other

Participants who have tested negative for SARS-CoV-2

Primary outcomes

  1. 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

  1. To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement

    Time frame: Up to 12 months

  2. To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing

    Time frame: Up to 12 months

  3. To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity

    Time frame: Up to 12 months

  4. To describe the feasibility of COVID-19 home testing

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Everly Health

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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