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

COVID-19 Clinical Trial

Official title:

Effectiveness of Self-proning and Repositioning in Outpatients With COVID-19: a Randomized Controlled Internal Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05518474
• Other study ID #: homeproningpilot_21_069
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication
• COVID-19
• COVID-19 Pneumonia
• Death
• Hospitalization
• Outpatient

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Unity Health Toronto	Applied Health Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility outcome: successful recruitment	Defined as >=50% of eligible participants agreeing to enrollment	Through study completion, on average one year
Other	Feasibility outcome: successful retention of trial participants,	Defined as <10% attrition rate	Up to 28 days
Other	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
Primary	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	Hospitalization		Up to 28 days post-randomization
Secondary	All cause mortality		Up to 28 days post-randomization
Secondary	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
Secondary	Use of antibiotics for respiratory illness		Up to 28 days post-randomization
Secondary	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