Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Death; Complication; COVID-19 Pneumonia; Hospitalization; Outpatient; Proning
• Intervention / Treatment: Other: Self-proning

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6R 1B5
      • St. Joseph's Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years
2. Positive SARS-CoV-2 PCR test

3. Presence of two or more of the following criteria:

   1. Age>55 years
   2. Fever by history or at presentation
   3. Cough
   4. Dyspnea/shortness of breath
   5. Fatigue necessitating daytime bed rest

   6. One or more of the following medical conditions:

      • Hypertension
      • Diabetes
      • Cardiovascular disease
      • Chronic lung disease
      • Chronic kidney disease
      • Obesity (BMI≥30kg/m2)
   7. Tachycardia > 110 bpm
   8. Oxygen saturation <94%

   9. 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
   10. Bilateral infiltrates or ground glass opacities on chest x-ray or CT scan
4. Socially and medically fit for discharge
5. Access to a smartphone

Exclusion Criteria:

1. Pregnancy >20/40 weeks
2. Body mass index (BMI) >40 kg/m2.
3. Skeletal deformities that interfere with proning
4. Developmental delay or cognitive impairment that would preclude patient cooperation
5. Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication.
6. Unlikely to adhere to the proning protocol according to the treating physician's judgment
7. Fully vaccinated for COVID-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-proning; 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.	Other: Self-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.; Other Names: Self-proning/repositioning; Home-proning
No Intervention: Standard care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 28 days post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization		Up to 28 days post-randomization
All cause mortality		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.	Up to 28 days post-randomization
Use of antibiotics for respiratory illness		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	Up to 28 days post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility outcome: successful recruitment	Defined as >=50% of eligible participants agreeing to enrollment	Through study completion, on average one year
Feasibility outcome: successful retention of trial participants,	Defined as <10% attrition rate	Up to 28 days
Feasibility outcome: adherence to the intervention	Defined as self-proning and repositioning daily for >=75% of days of symptom duration. Adherence will be ascertained through daily survey of study participants.	Up to 28 days

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Applied Health Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: homeproningpilot_21_069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No