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

NCT04477954 | Terminated Phase 2

• 1 other identifier: AAMHEI2020-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Covid19

Keywords

Hyperbaric Oxygen; Covid-19; Hypoxemia; Sars-CoV2; Hyperbaric Chamber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)

  30 days

• Development of Acute Respiratory Distress Syndrome (ARDS)

  30 days

• 30-day mortality

  30 days

• Hypotension with vasopressor requirement

  30 days

• Mortality

  45 days / 60 days / 90 days and 180 days

Other Outcomes (1)

• Adverse events

  4 hours finished session

Study Arms (2)

Experimental HBOT

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Interventions

Hyperbaric Oxygen COMBINATION_PRODUCT

Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)

Also known as: HBOT

Experimental HBOT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Asociación Argentina de Medicina Hiperbárica e Investigación: lead
• Hospital de Infecciosas Francisco Javier Muniz: collaborator
• Hospital General de Agudos D. F. Santojanni: collaborator
• Hospital Central de San Isidro Dr. Melchor Angel Posse: collaborator

Study Sites (3)

Hospital Central de San Isidro Dr. Angel Melchor Posse

San Isidro, Buenos Aires, 1641, Argentina

Location

Hospital de Infecciosas F. J. Muñiz

Buenos Aires, Buenos Aires F.D., 1282, Argentina

Location

Hospital General de Agudos D.F Santojanni

Buenos Aires, Buenos Aires F.D., 1408, Argentina

Location

MeSH Terms

Conditions

COVID-19; Hypoxia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Mariana Cannellotto, MD

  Asociación Argentina de Medicina Hiperbárica e Investigación

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: July 6, 2020
• Primary Completion: November 6, 2020
• Study Completion: December 30, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (3)