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Trial - NCT04715243


Column Value
Trial registration number NCT04715243
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04715243

First author
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Abdul Hakeem Al Hashim, MD

Contact
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

hashim@squ.edu.om

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-20

Recruitment status
Last imported at : Jan. 14, 2022, 10 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : May 31, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - > 18 years of age - confirmed covid-19 - within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (icu) - ards according to berlin definition (p/f < 300) or o2 saturation < 90% or rr > 30/min) in room air - standard oxygen therapy at flow rate < 15l/min x 60 minutes

Exclusion criteria
Last imported at : May 31, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- more than 48 hours of admission to the emergency department, high dependency or intensive care unit - more than 4 hours on niv or hfnc before enrolment - impending cardiopulmonary arrest - need for immediate endotracheal intubation - hemodynamic instability or life-threatening arrhythmias - gcs < 8 - active intracranial pathology or high icp - inability to cooperate or protect the airway - pregnancy - tracheostomy - dnr or refusing intubation - known type 2 respiratory failure - on chronic home oxygen therapy

Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sultan Qaboos University

Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Oman

Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

161

primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Rate of endotracheal intubation

Notes
Last imported at : Jan. 29, 2021, 12:31 a.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 : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 501, "treatment_name": "Face-mask non-invasive ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 565, "treatment_name": "Helmet non-invasive ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 575, "treatment_name": "High flow nasal cannula", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]