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

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ClinicalTrials.gov Identifier: NCT04344431
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Covid-19 Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19)
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Time to normalize the oxygen requirement (oxygeno-dependence) [ Time Frame: 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 :
  1. Days of hospitalization between the HBO group and the control group. [ Time Frame: 1 month ]
    Number of days with oxygen need, taking into account the predictors of bad outcome

  2. 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. [ Time Frame: 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.

  3. Days on invasive mechanical ventilation [ Time Frame: 1 month ]
    Days on invasive mechanical ventilation

  4. Mortality [ Time Frame: 1 month ]
    Mortality


Other Outcome Measures:
  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 [ Time Frame: 1 month ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344431


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

Locations
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France
Sainte Anne Military Teaching Hospital Recruiting
Toulon, France, 83130
Contact: Jean-Eric BLATTEAU, MD, PhD    483162189 ext +33    jean-eric.blatteau@intradef.gouv.fr   
Principal Investigator: Jean-Eric BLATTEAU, MD, PhD         
Sub-Investigator: Nicolas PALEIRON, MD         
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
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Principal Investigator: Jean-Eric BLATTEAU, MD, PhD Sainte-Anne military hospital
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04344431    
Other Study ID Numbers: 2020PPRC03
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Direction Centrale du Service de Santé des Armées:
Sars-CoV2
Pneumonia
Hypoxaemic
Oxygen-dependence
Hyperbaric oxygen
Respiratory decompensation
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections