| Trial registration number
|
NCT04359797 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04359797
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Todd W Rice, MD, MSc
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
todd.rice@vumc.org
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-04-24
|
Recruitment status
Last imported at : Sept. 1, 2021, 8:30 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
|
Blind 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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- this study will enroll all patients admitted to vumc who test positive for covid-19
and require supplemental oxygen, but are not yet mechanically ventilated.
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
- patients admitted on mechanical ventilation will be excluded from enrollment.
|
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
|
Vanderbilt University Medical Center
|
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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
United States
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Moderate disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
3: Moderate disease at enrollment
|
Total sample size
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov
|
501
|
primary outcome
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Arms
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "nan", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|