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Behavioural Intervention

PRONE POSITIONING for Acute Respiratory Distress Syndrome (COVID-PRONE Trial)

N/A
Waitlist Available
Led By Fahad Razak, MD, MSc
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 30 days, 90 days and 1 year after randomization
Awards & highlights

COVID-PRONE Trial Summary

COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

Eligible Conditions
  • Acute Respiratory Distress Syndrome
  • Coronavirus

COVID-PRONE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 90 days and 1 year after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 90 days and 1 year after randomization 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 outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more
Secondary outcome measures
Adverse events of prone positioning (i.e., venous thromboembolism, pneumonia)
Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more assessed at 30 days, 90 days and 1 year
In-hospital all-cause mortality
+4 more
Other outcome measures
Feasibility outcome: Adherence to prone positioning
Feasibility outcome: Change in oxygen saturation before and after prone positioning (to be measured for 72 hours beginning at the time of randomization), which will be calculated as
Feasibility outcome: Rate or serious adverse events

COVID-PRONE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PRONE POSITIONINGExperimental Treatment1 Intervention
Patients in this arm will be instructed to lie on their stomach while they are in bed for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for >24 hours or study outcome.
Group II: STANDARD OF CAREActive Control1 Intervention
Patients in this arm are not specifically instructed to lie on their stomach while they are in bed.

Find a Location

Who is running the clinical trial?

Toronto General HospitalOTHER
25 Previous Clinical Trials
15,114 Total Patients Enrolled
University Health Network, TorontoOTHER
1,472 Previous Clinical Trials
484,653 Total Patients Enrolled
William Osler Health SystemOTHER
10 Previous Clinical Trials
35,758 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prone Positioning for Patients on General Medical Wards With COVID19
2020. "Prone Positioning for Patients on General Medical Wards With COVID19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04383613.
All > Covid 19 > Covid
~69 spots leftby Apr 2025
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