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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Combination Product: Hyperbaric Oxygen

• Registration Number: NCT04477954
• Lead Sponsor: Asociación Argentina de Medicina Hiperbárica e Investigación

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Primary Completion: 2020-11-06
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental HBOT	Hyperbaric Oxygen	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.

Primary Outcome Measures

Name	Time	Method
Time to normalize the oxygen requirement (oxygen dependence)	15-30 days.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Central de San Isidro Dr. Angel Melchor Posse; 🇦🇷 San Isidro, Buenos Aires, Argentina

Hospital de Infecciosas F. J. Muñiz; 🇦🇷 Ciudad Autonoma de Buenos AIres, Caba, Argentina

Hospital General de Agudos D.F Santojanni; 🇦🇷 Ciudad Autonoma de Buenos AIres, Caba, Argentina