Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19) (OHB10cov)

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.

Study Overview

• Status: Recruiting
• Conditions: Covid-19
• Intervention / Treatment: Combination product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jean-Eric BLATTEAU, MD, PhD; Phone Number: +33 483162189; Email: jean-eric.blatteau@intradef.gouv.fr

Study Locations

• France
  • Marseille, France, 13013
    • Not yet recruiting
    • Hôpital d'Instruction des Armées Laveran
    • Contact: Emilie JAVELLE, MD; Phone Number: +33 491617504; Email: emilie.javelle@intradef.gouv.fr
  • Toulon, France, 83100
    • Not yet recruiting
    • Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
    • Contact: Nicolas DI STEFANO, MD; Phone Number: +33 494145290; Email: nicodiste@hotmail.fr
  • Toulon, France, 83130
    • Recruiting
    • Hôpital d'instruction des armées Sainte-Anne
    • Contact: Jean-Eric BLATTEAU, MD, PhD; Phone Number: +33 483162189; Email: jean-eric.blatteau@intradef.gouv.fr
    • Principal Investigator: Jean-Eric BLATTEAU, MD, PhD
    • Sub-Investigator: Nicolas PALEIRON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to normalize the oxygen requirement (oxygeno-dependence)	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	1 month
Days of hospitalization between the HBO group and the control group.	Number of days with oxygen need, taking into account the predictors of bad outcome	1 month
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.	Oxygen flow values to obtain a saturation by pulse oximetry greater than or equal to 92% between the OHB group and the control group.	1 month
Days on invasive mechanical ventilation	Days on invasive mechanical ventilation	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 month

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Investigators: Principal Investigator: Jean-Eric BLATTEAU, MD, PhD, Sainte-Anne military hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pneumonia; Hyperbaric oxygen; Sars-CoV2; Hypoxaemic; Oxygen-dependence; Respiratory decompensation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 2020PPRC03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No