Official Title
Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19)
Brief Summary

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.

Detailed Description

The main objective of this study is to assess the effectiveness of HBOT in addition to normal

management over the period of normalization of the oxygen requirement (oxygen dependence) in

patients with SAR-CoV2 pneumonia not requiring invasive or non-invasive ventilation. It is a

prospective, interventional, multicentre, controlled, randomized study. Patients admitted for

SARS-CoV2 pneumonia in the Covid sector of the hospital, who have oxygen-dependence criteria

will be proposed for inclusion in accordance with the inclusion and non-inclusion criteria.

Randomization will be carried out to determine the allocation in two groups: an HBO group

which will perform a daily session after checking for the absence of contraindication to HBO

and a non-HBO control group with the same clinical criteria, but who will not benefit from

HBOT sessions. In both groups, the standard continuous treatment with normobaric oxygen will

be maintained.

Recruiting
COVID-19

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
HBO group

Eligibility Criteria

Inclusion Criteria: - Male or female, Age ≥ 18 years - Patient with oxygen dependence criterion: need to maintain an oxygen flow rate less than or equal to 6 liters / min to obtain: saturation by pulse oximetry (SpO2) greater than or equal to 92% or arterial gas with value PaO2 greater than 60mmHg. - Diagnostic confirmation of SARS-CoV-2 pneumonia

Exclusion Criteria: - Minor subject (age

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 90 Years
Countries
France
Contacts

Jean-Eric BLATTEAU, MD, PhD
483162189 +33
jean-eric.blatteau@intradef.gouv.fr

Jean-Eric BLATTEAU, MD, PhD
Principal Investigator
Sainte-Anne military hospital

Direction Centrale du Service de Santé des Armées
NCT Number
Keywords
SARS-CoV2
Pneumonia
Hypoxaemic
Oxygen-dependence
Hyperbaric oxygen
Respiratory decompensation
MeSH Terms
Pneumonia