Covid19RiskSEARCHNCT04709068
Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
An observational study of Covid19, run by Current Health at 1 site in United States.
Trial summary
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Current Health
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- Living in the United States (contiguous states)
- Aged 21 years or older
- Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours
- Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily
- Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.
Who cannot join
- Under the age of 21
- Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19
- Cannot confirm a PCR or antigen positive test for COVID-19
- Is unable to read English
- Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire
- Is unwilling or unable to provide baseline data required for entry into the study
Show all 10Show fewer
- Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up
- Heavy tattooing on both upper arms
- Known atrial fibrillation (permanent or paroxysmal)
- Has taken/is taking part in a COVID-19 vaccine or treatment trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.
- Conditions
- Covid19
- Being tested
- Current Health
- Keywords
- wearable, at-home
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current HealthDevice
wearable device and tablet used to collect health measures at home
| Study group | Role | What they receive |
|---|---|---|
| COVID19+ | Not described Receives: Device: Current Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Compliance
a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start8 Feb 2021
- Primary completion3 May 2021
- Study completion1 Jun 2021
Why it stopped: recruitment and enrollment challenges due to fast-changing landscape of pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Current Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Adam Wolfberg, MD, Principal investigator, Current Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709068
- Sponsor's protocol ID
- Pro00047371
- Acronym
- RiskSEARCH
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
- ClinicalTrials.gov ID
- NCT04709068
- Acronym / sponsor ID
- RiskSEARCH / Pro00047371
- Conditions
- Covid19
- Keywords
- wearable, at-home
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment and enrollment challenges due to fast-changing landscape of pandemic
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Current HealthIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID19+ | – | Device: Current Health |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (5 listed)
- Living in the United States (contiguous states)
- Aged 21 years or older
- Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours
- Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily
- Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.
Key exclusion criteria (10 listed)
- Under the age of 21
- Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19
- Cannot confirm a PCR or antigen positive test for COVID-19
- Is unable to read English
- Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire
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 |
|---|---|---|
| Current Healthwearable device and tablet used to collect health measures at home | Device | COVID19+ |
Primary outcome
Participant Compliance
Time frame: up to 30 days
a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- study information and eligibility for enrollmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Adam Wolfberg, MD principal investigator
Current 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 Covid19, run by Current 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participant Compliance (time frame: up to 30 days). 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 19 Sep 2024.