Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19) (OHB10cov)
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|ClinicalTrials.gov Identifier: NCT04344431|
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 21, 2020
Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaric oxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal of hyperbaric medicine, treatment with repeated HBO sessions prevented admission to intensive care unit with mechanical ventilation in a patient aged 69 who presented with signs of respiratory decompensation. HBOT is the most powerful oxygenation modality in the body today. HBOT can dramatically increase the amount of dissolved oxygen in the blood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore, HBOT has specific immunomodulatory properties, both humoral and cellular, making it possible, for example, to reduce the intensity of the inflammatory response and to stimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT might also be involved. HBOT is generally regarded as safe with very few adverse events.
Following this feedback, it is proposed in the context of crisis management related to SARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed, it seems essential to propose therapeutic strategies to limit the risk of respiratory decompensation requiring admission to intensive care unit for patients with SARS-CoV2 pneumonia.
|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)||Phase 2 Phase 3|
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19)|
|Actual Study Start Date :||April 14, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||May 2021|
|Experimental: HBO group||
Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)
One session per day of HBOT in addition to the standard treatment with normobaric oxygen
|No Intervention: Non-HBO group|
- Time to normalize the oxygen requirement (oxygeno-dependence) [ Time Frame: 1 month ]Time to normalize the oxygen requirement (oxygeno-dependence), i.e. allowing a pulse oximetry value in ambient air greater than or equal to 92% and / or arterial blood gas with a PaO2 value greater than 60mmHg in ambient air.
- Days of hospitalization between the HBO group and the control group. [ Time Frame: 1 month ]Number of days with oxygen need, taking into account the predictors of bad outcome
- Oxygen flow values to obtain a saturation by pulse oximetry greater than or equal to 92% values between the HBO group and the control group. [ Time Frame: 1 month ]Oxygen flow values to obtain a saturation by pulse oximetry greater than or equal to 92% between the OHB group and the control group.
- Days on invasive mechanical ventilation [ Time Frame: 1 month ]Days on invasive mechanical ventilation
- Mortality [ Time Frame: 1 month ]Mortality
- Number of patients requiring a permanent O2 flow rate greater than 6 liters / min with high-speed nasal mask or oxygen therapy or with invasive or non-invasive ventilation [ Time Frame: 1 month ]Number of patients requiring a permanent O2 flow rate greater than 6 liters / min with high-speed nasal mask or oxygen therapy or with invasive or non-invasive ventilation
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): NCT04344431
|Contact: Jean-Eric BLATTEAU, MD, PhD||483162189 ext +firstname.lastname@example.org|
|Sainte Anne Military Teaching Hospital||Recruiting|
|Toulon, France, 83130|
|Contact: Jean-Eric BLATTEAU, MD, PhD 483162189 ext +33 email@example.com|
|Principal Investigator: Jean-Eric BLATTEAU, MD, PhD|
|Sub-Investigator: Nicolas PALEIRON, MD|
|Principal Investigator:||Jean-Eric BLATTEAU, MD, PhD||Sainte-Anne military hospital|