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

NCT ID: NCT05518474

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2023-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-proning

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Self-proning/repositioning; Home-proning

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Applied Health Research Centre

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Joseph's Health Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

homeproningpilot_21_069

Identifier Type: -

Identifier Source: org_study_id