| Trial registration number
|
NCT04375735 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04375735
|
First author
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
|
Jim Lewis, MD
|
Contact
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
|
Gordon Barkwell, gordon.barkwell@lhsc.on.ca (PI email not reported)
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-05-05
|
Recruitment status
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
multi-center
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
age over 18 years
definitive proof of covid-19 infection within 48 hours of intubation
acute respiratory failure with pao2/fio2 < 300 requiring intubation
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
known or high suspicion of pre-existing heart failure, unstable angina
presence of severe shock with hemodynamic instability despite escalating vasopressors
severe, underlying lung disease (copd, pulmonary fibrosis, lung cancer. etc.)
concurrent treatments are delivered directly into the lung (ie anesthetics etc)
diagnosis of pulmonary hemorrhage
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Lawson Health Research Institute
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Countries
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
|
Canada
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Critical disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
20
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Adverse events (patient) - Decrease in hemodynamics;Adverse events (patient) - Decrease in oxygenation;Adverse event (healthcare worker) - Circuit breach;Adverse event (healthcare worker) - COVID-19 symptoms
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 1/Phase 2
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 228, "treatment_name": "Bovine lipid extract surfactant", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|