Prone Positioning for Patients on General Medical Wards With COVID19

NCT04383613 | Unknown

• 1 other identifier: 2020-1
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 8

Brief Summary

COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

Conditions

Covid-19; ARDS

Outcome Measures

Primary Outcomes (1)

• Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more

  From date of randomization until the date of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks

Secondary Outcomes (7)

• Length of hospitalization

  Up to 4 weeks [or until hospital discharge]

• Adverse events of prone positioning (i.e., venous thromboembolism, pneumonia)

  Up to 7 days [or until hospital discharge]

• In-hospital all-cause mortality

  From date of randomization until the date of in-hospital all-cause mortality or date of hospital discharge, whichever came first, assessed up to 4 weeks

• Invasive or non-invasive mechanical ventilation

  From date of randomization until the date of invasive or non-invasive mechanical ventilation, or date of hospital discharge, whichever came first, assessed up to 4 weeks

• Need for FiO2 of 60% or more

  From date of randomization until the date of need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks

Other Outcomes (3)

• Feasibility outcome: Change in oxygen saturation before and after prone positioning (to be measured for 72 hours beginning at the time of randomization), which will be calculated as:

  72 hours

• Feasibility outcome: Rate or serious adverse events

  Up to 7 days

• Feasibility outcome: Adherence to prone positioning

  Day 3 and day 7

Study Arms (2)

PRONE POSITIONING

EXPERIMENTAL

Patients in this arm will be instructed to lie on their stomach while they are in bed for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for \>24 hours or study outcome.

Other: Prone positioning

STANDARD OF CARE

NO INTERVENTION

Patients in this arm are not specifically instructed to lie on their stomach while they are in bed.

Interventions

Prone positioning OTHER

The intervention is prone positioning (i.e., instructing a patient to lie on their stomach while they are in bed) for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for \>24 hours or study outcome. Patients will be asked to aim for prone positioning four times per day for at least two hours each time, and will be encouraged to sleep on their stomach at night.

PRONE POSITIONING

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age
• COVID-19 infection is suspected by the treating clinician or confirmed by diagnostic test
• Able to lie on their stomach with verbal instruction
• Requiring supplemental oxygen less than or equal to 50% FiO2
• Capable to make treatment related decisions
• Hospitalized in the last 48 hours with suspected or confirmed COVID-19 infection or diagnosed for nosocomial infection in the last 48 hours during their hospital stay

You may not qualify if:

• Inability to follow commands (e.g., delirium, dementia)
• indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration)
• contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic fracture, unstable airway, open chest or abdomen, anterior chest tube, recent abdominal surgery in past 14 days)
• patients on home CPAP (continue positive airway pressure)
• transfer from ICU in past 72 hours
• need for telemetry at the time of randomization
• pregnant (i.e., more than 20 weeks)
• body mass index above 40 kg/m2 (based on clinician's assessment)
• Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
• severe hemoptysis
• pace-maker inserted in past 48 hours

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Sinai Health System: collaborator
• Toronto General Hospital: collaborator
• University Health Network, Toronto: collaborator
• William Osler Health System: collaborator

Study Sites (8)

William Osler Health System

Brampton, Ontario, Canada

Location

William Osler Health System

Etobicoke, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• Fralick M, Colacci M, Munshi L, Venus K, Fidler L, Hussein H, Britto K, Fowler R, da Costa BR, Dhalla I, Dunbar-Yaffe R, Branfield Day L, MacMillan TE, Zipursky J, Carpenter T, Tang T, Cooke A, Hensel R, Bregger M, Gordon A, Worndl E, Go S, Mandelzweig K, Castellucci LA, Tamming D, Razak F, Verma AA; COVID Prone Study Investigators. Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE). BMJ. 2022 Mar 23;376:e068585. doi: 10.1136/bmj-2021-068585.

  PMID: 35321918 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Fralick, MD, PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Fahad Razak, MD, MSc

  St. Michael's Hospital (Unity Health Toronto)

  PRINCIPAL INVESTIGATOR

• Amol Verma, MD, MPhil

  St. Michael's Hospital (Unity Health Toronto)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will be unblinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 12, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)