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Trial - NCT04477954


Column Value
Trial registration number NCT04477954
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04477954

First author
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mariana Cannellotto, MD

Contact
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

mariana.cannellotto@aamhei.org

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-20

Recruitment status
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Terminated

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - 18 years, all sexes. - no previous hospitalizations in the last 6 months. - positive diagnostic test for covid-19 according to the guidelines of the argetine ministry of health at the time of enrollment. - patient in intensive care unit with oxygen need: need for continuous supply of oxygen to maintain saturation by oximetry pulse (spo2) greater than or equal to 93% or arterial gas with pao2 value greater than 60 mmhg

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 18 years of age. - person unable to give consent. - person who refuses to participate. - pregnancy and lactation - participating in other study - requirement for mechanical ventilation. - inability to maintain prolonged sitting position (at least 2 hours) - subject with contraindications to hbot (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade iii or iv).

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

Asociación Argentina de Medicina Hiperbárica e Investigación

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

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Argentina

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 : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

40

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Time to normalize the oxygen requirement (oxygen dependence)

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 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 608, "treatment_name": "Hyperbaric oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]