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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

NCT04619719

Covid19

TERMINATED NA

Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

NCT04500626

Covid19

UNKNOWN PHASE2/PHASE3

Pulmonary Function After Hyperbaric Oxygen Therapy

NCT05088772

Oxygen Toxicity

COMPLETED

Hyperbaric Oxygen for COVID-19 Patients

NCT04332081

COVID-19

TERMINATED NA

Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia

NCT04477954

Covid19

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HBO group

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

Non-HBO group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No