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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Combination product: Hyperbaric Oxygen

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • San Isidro, Buenos Aires, Argentina, 1641
      • Hospital Central de San Isidro Dr. Angel Melchor Posse
  • Caba
    • Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1282
      • Hospital de Infecciosas F. J. Muñiz
    • Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1408
      • Hospital General de Agudos D.F Santojanni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Experimental HBOT; 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; Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430); Other Names: HBOT

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of adverse events reported related to the device (Revitalair 430 hyperbaric chamber): otalgias, ear obstruction, barotrauma, significant and constant changes in blood pressure, heart rate and others	4 hours finished session

Collaborators and Investigators

• Sponsor: Asociación Argentina de Medicina Hiperbárica e Investigación
• Collaborators: Hospital de Infecciosas Francisco Javier Muniz; Hospital General de Agudos D. F. Santojanni; Hospital Central de San Isidro Dr. Melchor Angel Posse
• Investigators: Study Chair: Mariana Cannellotto, MD, Asociación Argentina de Medicina Hiperbárica e Investigación; Principal Investigator: Mariano Duarte, PhD, Asociación Argentina de Medicina Hiperbárica e Investigación; Principal Investigator: Liliana Jorda-Vargas, Asociación Argentina de Medicina Hiperbárica e Investigación; Principal Investigator: Fabrizio Verdini, MD, Asociación Argentina de Medicina Hiperbárica e Investigación

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Covid-19; Hyperbaric Oxygen; Sars-CoV2; Hypoxemia; Hyperbaric Chamber
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Hypoxia
• Other Study ID Numbers: AAMHEI2020-1

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
• product manufactured in and exported from the U.S.: No