COVID-19NCT05518474
Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness
A study testing Self-proning in people with COVID-19 and COVID-19 Pneumonia, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID-19 Pneumonia, Proning
- What is being tested?
- Self-proning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2021to 1 Feb 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Positive SARS-CoV-2 PCR test
- Presence of two or more of the following criteria:
- Age>55 years
- Fever by history or at presentation
- Cough
Show all 26Show fewer
- Dyspnea/shortness of breath
- Fatigue necessitating daytime bed rest
- One or more of the following medical conditions:
- Hypertension
- Diabetes
- Cardiovascular disease
- Chronic lung disease
- Chronic kidney disease
- Obesity (BMI≥30kg/m2)
- Tachycardia > 110 bpm
- Oxygen saturation <94%
- One or more of the following laboratory abnormalities:
- Lymphocytes <1500/microL
- ESR > 100 mm/h
- CRP > 10 mg/L
- D-Dimer > 1000 ng/mL
- LDH > 240 U/L
- Bilateral infiltrates or ground glass opacities on chest x-ray or CT scan
- Socially and medically fit for discharge
- Access to a smartphone
Who cannot join
- Pregnancy >20/40 weeks
- Body mass index (BMI) >40 kg/m2.
- Skeletal deformities that interfere with proning
- Developmental delay or cognitive impairment that would preclude patient cooperation
- Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication.
- Unlikely to adhere to the proning protocol according to the treating physician's judgment
- Fully vaccinated for COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Self-proning and Repositioning in Outpatients With COVID-19: a Randomized Controlled Internal Pilot Trial
The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. "Proning" or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or "main trial", meaning it will be small scale test of methods and procedures to be used on a larger scale.
- Conditions
- COVID-19, COVID-19 Pneumonia, Proning, Hospitalization, Death, Outpatient
- Being tested
- Self-proning
- Medical subject headings
- COVID-19, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-proningOther
Also called Self-proning/repositioning, Home-proning
Rotating between lying flat with the chest down, on one's side or sitting up every 30 minutes to 2 hours when lying down during the day or while sleeping at night.
| Study group | Role | What they receive |
|---|---|---|
| Self-proning | Experimental | Participants assigned to the intervention arm will receive a SMS link to a PDF containing instructions on proning/repositioning and information about its physiological benefits. They'll also receive a PDF with standard recommendations for treating COVID-19 at home. Participants will be encouraged to lie flat on their belly, on their side, or sit upright and rotate between these positions when lying down during the day and night. Participants will be sent a daily SMS "proning reminder" and asked to complete a secure REDCap survey regarding their proning activity. They'll be advised to prone and reposition for seven days minimum whenever they are lying down. Participants who have failed to reach their functional baseline after this time period will be advised to continue doing so. Follow up assessment by telephone will be conducted in 7 day increments from baseline up to 28 days. Receives: Other: Self-proning |
| Standard care | No intervention | Participants assigned to the comparator arm will receive a SMS link to a PDF with standard recommendations for treating COVID-19 at home. This includes antipyretics and analgesics for fever, myalgias, and headaches; hydration; and rest with advancement of activity as soon as tolerated. Follow up assessment by telephone will be conducted in 7 day increments from baseline up to 28 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of hospitalization and all cause mortality
The primary outcome is a composite of hospital admission and all-cause mortality. This will be ascertained using telephone follow up and deterministic record linkage performed by the Institute for Clinical Evaluative Sciences (ICES) using their Discharge Abstract Database (DAD).
Measured: Up to 28 days post-randomization
Secondary outcomes (5)
Hospitalization
Measured: Up to 28 days post-randomization
All cause mortality
Measured: Up to 28 days post-randomization
Time to functional recovery in days
Defined as: resolution of fever for 48 hours, significant symptom reduction and ability to perform most daily activities or return to work, if applicable, for two consecutive days.
Measured: Up to 28 days post-randomization
Use of antibiotics for respiratory illness
Measured: Up to 28 days post-randomization
Follow up emergency department assessment without hospital admission
Number of subsequent emergency department visits by study participants that relate to the initial COVID-19 presentation but do not result in hospital admission
Measured: Up to 28 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start15 Oct 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Insufficient participant enrollment due to dwindling case numbers/case severity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, pragmatic, randomized controlled internal pilot trial (vanguard phase)
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Health Research Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518474
- Sponsor's protocol ID
- homeproningpilot_21_069
- Status last verified
- May 2023
- First submitted
- 22 Aug 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-proning and Repositioning in Outpatients With COVID-19: a Randomized Controlled Internal Pilot Trial
- ClinicalTrials.gov ID
- NCT05518474
- Acronym / sponsor ID
- homeproningpilot_21_069
- Conditions
- COVID-19, COVID-19 Pneumonia, Proning, Hospitalization, Death, Outpatient
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient participant enrollment due to dwindling case numbers/case severity
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Applied Health Research Centre
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 Aug 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.
The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. "Proning" or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or "main trial", meaning it will be small scale test of methods and procedures to be used on a larger scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, pragmatic, randomized controlled internal pilot trial (vanguard phase)
| Arm | Type | Receives |
|---|---|---|
| Self-proning | Experimental | Other: Self-proningParticipants assigned to the intervention arm will receive a SMS link to a PDF containing instructions on proning/repositioning and information about its physiological benefits. They'll also receive a PDF with standard recommendations for treating COVID-19 at home. Participants will be encouraged to lie flat on their belly, on their side, or sit upright and rotate between these positions when lying down during the day and night. Participants will be sent a daily SMS "proning reminder" and asked to complete a secure REDCap survey regarding their proning activity. They'll be advised to prone and reposition for seven days minimum whenever they are lying down. Participants who have failed to reach their functional baseline after this time period will be advised to continue doing so. Follow up assessment by telephone will be conducted in 7 day increments from baseline up to 28 days. |
| Standard care | No intervention | –Participants assigned to the comparator arm will receive a SMS link to a PDF with standard recommendations for treating COVID-19 at home. This includes antipyretics and analgesics for fever, myalgias, and headaches; hydration; and rest with advancement of activity as soon as tolerated. Follow up assessment by telephone will be conducted in 7 day increments from baseline up to 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age ≥18 years
- Positive SARS-CoV-2 PCR test
- Presence of two or more of the following criteria:
- Socially and medically fit for discharge
- Access to a smartphone
Key exclusion criteria (7 listed)
- Pregnancy >20/40 weeks
- Body mass index (BMI) >40 kg/m2.
- Skeletal deformities that interfere with proning
- Developmental delay or cognitive impairment that would preclude patient cooperation
- Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication.
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 |
|---|---|---|
| Self-proningAlso: Self-proning/repositioning, Home-proningRotating between lying flat with the chest down, on one's side or sitting up every 30 minutes to 2 hours when lying down during the day or while sleeping at night. | Other | Self-proning |
Primary outcome
Composite of hospitalization and all cause mortality
Time frame: Up to 28 days post-randomization
The primary outcome is a composite of hospital admission and all-cause mortality. This will be ascertained using telephone follow up and deterministic record linkage performed by the Institute for Clinical Evaluative Sciences (ICES) using their Discharge Abstract Database (DAD).
5 secondary outcomes
Hospitalization
Time frame: Up to 28 days post-randomization
All cause mortality
Time frame: Up to 28 days post-randomization
Time to functional recovery in days
Time frame: Up to 28 days post-randomization
Use of antibiotics for respiratory illness
Time frame: Up to 28 days post-randomization
Follow up emergency department assessment without hospital admission
Time frame: Up to 28 days post-randomization
Results and safety
The study was stopped early (reason given: Insufficient participant enrollment due to dwindling case numbers/case severity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes
Related trials for COVID-19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-proning in people with COVID-19 and COVID-19 Pneumonia, run by Unity Health Toronto at 1 site in Canada.
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 26 inclusion and 7 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 11 May 2023. 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 Canada. 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 was stopped early (reason given: Insufficient participant enrollment due to dwindling case numbers/case severity). Results are not available in the source record.
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?
Composite of hospitalization and all cause mortality (time frame: Up to 28 days post-randomization). 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 11 May 2023.