Self-proning for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Joseph's Health Centre, Toronto, Canada
COVID19 (disease)+8 More
Self-proning - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. 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.

Eligible Conditions

  • COVID19 (disease)
  • Pneumonia
  • COVID-19
  • Proning
  • Death
  • Hospitalizations
  • Outpatients
  • Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID19 (disease)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Through study completion, on average one year

Through study completion, on average one year
Feasibility outcome: successful recruitment
Up to 28 days
Feasibility outcome: adherence to the intervention
Feasibility outcome: successful retention of trial participants
Day 28
All cause mortality
Composite of hospitalization and all cause mortality
Follow up emergency department assessment without hospital admission
Hospitalization
Time to functional recovery in days
Use of antibiotics for respiratory illness

Trial Safety

Safety Progress

1 of 3

Other trials for COVID19 (disease)

Trial Design

2 Treatment Groups

Standard care
1 of 2
Self-proning
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Self-proning · No Placebo Group · N/A

Self-proning
Other
Experimental Group · 1 Intervention: Self-proning · Intervention Types: Other
Standard careNoIntervention Group · 1 Intervention: Standard care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, on average one year
Closest Location: St. Joseph's Health Centre · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2011First Recorded Clinical Trial
0 TrialsResearching COVID19 (disease)
26 CompletedClinical Trials

Who is running the clinical trial?

Applied Health Research CentreOTHER
21 Previous Clinical Trials
71,707 Total Patients Enrolled
Unity Health TorontoLead Sponsor
484 Previous Clinical Trials
362,041 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive SARS-CoV-2 PCR test.
You have dyspnea/shortness of breath.
You have a cardiovascular disease.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.