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

Study Overview
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Brief Summary
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The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.

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

Conditions
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Covid19

Intervention / Treatment
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* Combination Product: Hyperbaric Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years, all sexes. No previous hospitalizations in the last 6 months. Positive diagnostic test for COVID-19 according to the guidelines of the Argetine Ministry of Health at the time of enrollment. Patient in Intensive Care Unit with oxygen need: Need for continuous supply of oxygen to maintain saturation by oximetry pulse (SpO2) greater than or equal to 93% or arterial gas with PaO2 value greater than 60 mmHg Exclusion Criteria: 18 years of age. Person unable to give consent. Person who refuses to participate. Pregnancy and lactation Participating in other study Requirement for mechanical ventilation. Inability to maintain prolonged sitting position (at least 2 hours) Subject with contraindications to HBOT (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade III or IV).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental HBOT<br>Treatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen. | Combination Product: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)<br>* Other names: HBOT;|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to normalize the oxygen requirement (oxygen dependence) | Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air. | 15-30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) | Number of patients who required IMV after being enrolled | 30 days | 
| Development of Acute Respiratory Distress Syndrome (ARDS) | Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled. | 30 days | 
| 30-day mortality | Number of patients who died in that period since enrollment | 30 days | 
| Hypotension with vasopressor requirement | Number of patients with hypotension who were administered vasopressors in this period | 30 days | 
| Mortality | Number of patients who died in that period since enrollment. | 45 days / 60 days / 90 days and 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric Oxygen, Covid-19, Hypoxemia, Sars-CoV2, Hyperbaric Chamber