SARS CoV 2 InfectionOVER-COVIDNCT05302960
Recovering From COVID-19
An observational study of SARS CoV 2 Infection, run by Imperial College London.
Trial summary
Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Fitbit
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 8 Apr 2024
- 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
- Adult, Older adult
Study population: •Discharged from hospital with a RT-PCR SAR-CoV-2 positive swab result.
Who may be able to join
- Aged 18 years or over.
- Able to provide written consent.
Who cannot join
- Any participants that withdraw their consent.
- Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
- Inability to cooperate or communicate with the research team.
About this study
Official title: Recovering From COVID-19: Community-based Remote Monitoring in COVID-19 (SARS-CoV 2) Cases: The OVER-COVID Study
Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached.
There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile.
However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps
- Conditions
- SARS CoV 2 Infection
- Being tested
- Fitbit
- Keywords
- monitoring, ambulatory, vital signs, remote monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
The use of Fitbit sensors to see if activity levels can be improved to track recovery from COVID
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
step count recorded from Fitbit devices
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start30 Nov 2021 (estimated)
- Primary completion8 Apr 2024 (estimated)
- Study completion8 Apr 2024 (estimated)
Why it stopped: Decline in Covid Cases (not feasible to recruit)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302960
- Sponsor's protocol ID
- 21IC6755
- Acronym
- OVER-COVID
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2022
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering From COVID-19: Community-based Remote Monitoring in COVID-19 (SARS-CoV 2) Cases: The OVER-COVID Study
- ClinicalTrials.gov ID
- NCT05302960
- Acronym / sponsor ID
- OVER-COVID / 21IC6755
- Conditions
- SARS CoV 2 Infection
- Keywords
- monitoring, ambulatory, vital signs, remote monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Decline in Covid Cases (not feasible to recruit)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 8 Apr 2024 (estimated)
- Study completion
- 8 Apr 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached.
There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile.
However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- •Discharged from hospital with a RT-PCR SAR-CoV-2 positive swab result.
Key inclusion criteria (2 listed)
- Aged 18 years or over.
- Able to provide written consent.
Key exclusion criteria (3 listed)
- Any participants that withdraw their consent.
- Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
- Inability to cooperate or communicate with the research team.
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 |
|---|---|---|
| FitbitThe use of Fitbit sensors to see if activity levels can be improved to track recovery from COVID | Device | – |
Primary outcome
Step count
Time frame: up to 1 year
step count recorded from Fitbit devices
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection, run by Imperial College London.
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 3 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: withdrawn, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Step count (time frame: up to 1 year). 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 25 Apr 2024.