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

NCT04344431 | Unknown Phase 2 DMC

• 1 other identifier: 2020PPRC03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid-19

Keywords

Sars-CoV2; Pneumonia; Hypoxaemic; Oxygen-dependence; Hyperbaric oxygen; Respiratory decompensation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Days of hospitalization 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% values between the HBO group and the control group.

  1 month

• Days on invasive mechanical ventilation

  1 month

• Mortality

  1 month

Other Outcomes (1)

• 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

Study Arms (2)

HBO group

EXPERIMENTAL

Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)

Non-HBO group

NO INTERVENTION

Interventions

Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device) COMBINATION_PRODUCT

One session per day of HBOT in addition to the standard treatment with normobaric oxygen

HBO group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (3)

Hôpital d'Instruction des Armées Laveran

Marseille, 13013, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

Toulon, 83100, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83130, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Eric BLATTEAU, MD, PhD

  Sainte-Anne military hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Eric BLATTEAU, MD, PhD

CONTACT

483162189; jean-eric.blatteau@intradef.gouv.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: April 14, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)