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

NCT05518474 | Terminated

• 1 other identifier: homeproningpilot_21_069
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; COVID-19 Pneumonia; Proning; Hospitalization; Death; Outpatient; Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospitalization

  Up to 28 days post-randomization

• All cause mortality

  Up to 28 days post-randomization

• Time to functional recovery in 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

  Up to 28 days post-randomization

Other Outcomes (3)

• Feasibility outcome: successful recruitment

  Through study completion, on average one year

• Feasibility outcome: successful retention of trial participants,

  Up to 28 days

• Feasibility outcome: adherence to the intervention

  Up to 28 days

Study Arms (2)

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.

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.

Interventions

Self-proning OTHER

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.

Also known as: Self-proning/repositioning, Home-proning

Self-proning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Applied Health Research Centre: collaborator

Study Sites (1)

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

MeSH Terms

Conditions

COVID-19; Death

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, pragmatic, randomized controlled internal pilot trial (vanguard phase)

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 26, 2022
• Study Start: October 15, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)