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Self-proning for COVID-19

N/A
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average one year
Awards & highlights

Study Summary

This trial will test whether lying face down or sitting up can prevent mild cases of COVID-19 from becoming more severe, resulting in fewer hospitalizations and death.

Eligible Conditions
  • COVID-19
  • Complications
  • Coronavirus Pneumonia
  • Coronavirus
  • Prone Positioning
  • Hospitalizations
  • Death
  • Outpatient

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of hospitalization and all cause mortality
Secondary outcome measures
All cause mortality
Follow up emergency department assessment without hospital admission
Hospitalization
+2 more
Other outcome measures
Feasibility outcome: adherence to the intervention
Feasibility outcome: successful recruitment
Feasibility outcome: successful retention of trial participants

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-proningExperimental Treatment1 Intervention
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.
Group II: Standard careActive Control1 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.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
536 Previous Clinical Trials
447,518 Total Patients Enrolled
12 Trials studying COVID-19
16,292 Patients Enrolled for COVID-19
Applied Health Research CentreOTHER
22 Previous Clinical Trials
71,025 Total Patients Enrolled
1 Trials studying COVID-19
67 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are participating in this trial?

"Affirmative. Clinicaltrials.gov presents evidence that this trial, initially posted on October 15th 2021, is currently searching for 50 individuals to participate at a single location."

Answered by AI

Are there any remaining openings for participants of this scientific experiment?

"The details on clinicaltrials.gov indicate that this research endeavour is currently looking for participants; it was first posted on October 15th 2021 and the entry was most recently modified on August 24th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness
Roisin McElroy, MD MPH 2021. "Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05518474.
~3 spots leftby Apr 2025
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