NCT05042232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

September 9, 2021

Last Update Submit

June 14, 2022

Conditions

SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (1)

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

    Up to 12 months

Secondary Outcomes (4)

  • 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

Interventions

SARS-CoV-2 PositiveOTHER

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

SARS-CoV-2 NegativeOTHER

Participants who have tested negative for SARS-CoV-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have valid COVID-19 test results.

You may qualify if:

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

You may not qualify if:

  • \- Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Everlywell, Inc

Austin, Texas, 78703, United States

Location

Study Officials

  • Timothy Bauer, PhD

    Everly Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 13, 2021

Study Start

April 19, 2021

Primary Completion

May 15, 2022

Study Completion

June 14, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

US(1)