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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04477954
• Other study ID #: AAMHEI2020-1
• Status: Terminated
• Phase: Phase 2
• Start date: July 6, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Asociación Argentina de Medicina Hiperbárica e Investigación
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Covid19
• Hypoxia

Intervention

Combination Product:
• Hyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)

Locations

Country	Name	City	State
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	Hospital Central de San Isidro Dr. Angel Melchor Posse	San Isidro	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
Asociación Argentina de Medicina Hiperbárica e Investigación	Hospital Central de San Isidro Dr. Melchor Angel Posse, Hospital de Infecciosas Francisco Javier Muniz, Hospital General de Agudos D. F. Santojanni

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)	Number of patients who required IMV after being enrolled	30 days
Secondary	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
Secondary	30-day mortality	Number of patients who died in that period since enrollment	30 days
Secondary	Hypotension with vasopressor requirement	Number of patients with hypotension who were administered vasopressors in this period	30 days
Secondary	Mortality	Number of patients who died in that period since enrollment.	45 days / 60 days / 90 days and 180 days