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

Phase

2/3

Condition

Pneumonia

Covid-19

Treatment

N/A

Clinical Study ID

NCT04344431

2020PPRC03

Ages 18-90
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Minor subject (age <18 years)
Person unable to give consent
Refusal to participate
Pregnancy
Participating in another research
Signs of respiratory decompensation requiring mechanical ventilation
Diagnosis of pneumonia with SARS-CoV-2 not confirmed
Oxygen dependence criterion exceeded i.e. need to maintain an oxygen flow rate greaterthan or equal to 6 liters / min to obtain: saturation by pulse oximetry (SpO2) greaterthan or equal to 92% or arterial gas with value of PaO2 greater than 60mmHg.
Inability to maintain the prolonged sitting position (at least 2 hours)
Subject with contraindications to HBOT

Study Design

April 14, 2020

April 30, 2022

Study 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.

Connect with a study center

Hôpital d'Instruction des Armées Laveran
Marseille, 13013
France
Site Not Available
Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
Toulon, 83100
France
Site Not Available
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83130
France
Active - Recruiting

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