Clinical trial NCT05518474: Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness
Official title: Effectiveness of Self-proning and Repositioning in Outpatients With COVID-19: a Randomized Controlled Internal Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
COVID-19 Pneumonia
Proning
Hospitalization
Death
Outpatient
Complication
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Applied Health Research Centre
First posted: 2022-08-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, pragmatic, randomized controlled internal pilot trial (vanguard phase)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Composite of hospitalization and all cause mortality
timeFrame: Up to 28 days post-randomization
Secondary outcomes:
measure: Hospitalization
timeFrame: Up to 28 days post-randomization
measure: All cause mortality
timeFrame: Up to 28 days post-randomization
measure: Time to functional recovery in days
timeFrame: Up to 28 days post-randomization
measure: Use of antibiotics for respiratory illness
timeFrame: Up to 28 days post-randomization
measure: Follow up emergency department assessment without hospital admission
timeFrame: Up to 28 days post-randomization
Other outcomes:
measure: Feasibility outcome: successful recruitment
timeFrame: Through study completion, on average one year
measure: Feasibility outcome: successful retention of trial participants,
timeFrame: Up to 28 days
measure: Feasibility outcome: adherence to the intervention
timeFrame: Up to 28 days
Locations:
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
References: