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

Phase 2

• Conditions: Covid-19
• Interventions: Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)

• Registration Number: NCT04344431
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-11
• Study Start: 2020-04-14
• Study First Posted: 2020-04-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 <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 greater 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 of PaO2 greater than 60mmHg.
• Inability to maintain the prolonged sitting position (at least 2 hours)
• Subject with contraindications to HBOT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBO group	Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)	-

Primary Outcome Measures

Name	Time	Method
Time to normalize the oxygen requirement (oxygeno-dependence)	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	1 month	Mortality
Days of hospitalization between the HBO group and the control group.	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.	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	1 month	Days on invasive mechanical ventilation

Trial Locations

Locations (3)

Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer; 🇫🇷 Toulon, France

Hôpital d'Instruction des Armées Laveran; 🇫🇷 Marseille, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France