Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
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ClinicalTrials.gov Identifier: NCT04477954 |
Recruitment Status :
Terminated
(Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.)
First Posted : July 20, 2020
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Combination Product: Hyperbaric Oxygen | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia |
Actual Study Start Date : | July 6, 2020 |
Actual Primary Completion Date : | November 6, 2020 |
Actual Study Completion Date : | December 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental HBOT
Treatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen.
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Combination Product: Hyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Other Name: HBOT |
No Intervention: Standard care |
- Time to normalize the oxygen requirement (oxygen dependence) [ Time Frame: 15-30 days. ]Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air.
- Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) [ Time Frame: 30 days ]Number of patients who required IMV after being enrolled
- Development of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 30 days ]Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled.
- 30-day mortality [ Time Frame: 30 days ]Number of patients who died in that period since enrollment
- Hypotension with vasopressor requirement [ Time Frame: 30 days ]Number of patients with hypotension who were administered vasopressors in this period
- Mortality [ Time Frame: 45 days / 60 days / 90 days and 180 days ]Number of patients who died in that period since enrollment.
- Adverse events [ Time Frame: 4 hours finished session ]Number of adverse events reported related to the device (Revitalair 430 hyperbaric chamber): otalgias, ear obstruction, barotrauma, significant and constant changes in blood pressure, heart rate and others

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477954
Argentina | |
Hospital Central de San Isidro Dr. Angel Melchor Posse | |
San Isidro, Buenos Aires, Argentina, 1641 | |
Hospital de Infecciosas F. J. Muñiz | |
Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1282 | |
Hospital General de Agudos D.F Santojanni | |
Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1408 |
Study Chair: | Mariana Cannellotto, MD | Asociación Argentina de Medicina Hiperbárica e Investigación | |
Principal Investigator: | Mariano Duarte, PhD | Asociación Argentina de Medicina Hiperbárica e Investigación | |
Principal Investigator: | Liliana Jorda-Vargas | Asociación Argentina de Medicina Hiperbárica e Investigación | |
Principal Investigator: | Fabrizio Verdini, MD | Asociación Argentina de Medicina Hiperbárica e Investigación |
Responsible Party: | Mariana Cannellotto, President, Asociación Argentina de Medicina Hiperbárica e Investigación |
ClinicalTrials.gov Identifier: | NCT04477954 |
Other Study ID Numbers: |
AAMHEI2020-1 |
First Posted: | July 20, 2020 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Hyperbaric Oxygen Covid-19 Hypoxemia Sars-CoV2 Hyperbaric Chamber |
COVID-19 Hypoxia Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory |