SARS-CoV-2 Acute Respiratory DiseaseNCT05042232
A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by Everly Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- SARS-CoV-2 Positive and SARS-CoV-2 Negative
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 14 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who have valid COVID-19 test results.
Who may be able to join
- Age >=18 years
- Individuals with a valid diagnostic COVID-19 test result
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed 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.
Read the 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.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- SARS-CoV-2 Positive, SARS-CoV-2 Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19
Measured: 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
Measured: Up to 12 months
To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing
Measured: Up to 12 months
To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity
Measured: Up to 12 months
To describe the feasibility of COVID-19 home testing
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start19 Apr 2021
- Primary completion15 May 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everly Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bauer, PhD, Principal investigator, Everly Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042232
- Sponsor's protocol ID
- EW-US-4010-0003
- Status last verified
- Jun 2022
- First submitted
- 9 Sep 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT05042232
- Acronym / sponsor ID
- EW-US-4010-0003
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Everly HealthIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have valid COVID-19 test results.
Key inclusion criteria (2 listed)
- Age >=18 years
- Individuals with a valid diagnostic COVID-19 test result
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 PositiveParticipants who have tested positive for SARS-CoV-2, both with and without symptoms | Other | – |
| SARS-CoV-2 NegativeParticipants who have tested negative for SARS-CoV-2 | Other | – |
Primary outcome
To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19
Time frame: Up to 12 months
4 secondary outcomes
To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement
Time frame: Up to 12 months
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
To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity
Time frame: Up to 12 months
To describe the feasibility of COVID-19 home testing
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Bauer, PhD principal investigator
Everly Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by Everly Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19 (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.