Clinical trial NCT04477954: Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
Official title: Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: Hyperbaric Oxygen
Covid-19
Hypoxemia
Sars-CoV2
Hyperbaric Chamber
Lead sponsor: Asociación Argentina de Medicina Hiperbárica e Investigación
Sponsor class: OTHER
Collaborators: name: Hospital de Infecciosas Francisco Javier Muniz
name: Hospital General de Agudos D. F. Santojanni
name: Hospital Central de San Isidro Dr. Melchor Angel Posse
First posted: 2020-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time to normalize the oxygen requirement (oxygen dependence)
timeFrame: 15-30 days.
Secondary outcomes:
measure: Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)
timeFrame: 30 days
measure: Development of Acute Respiratory Distress Syndrome (ARDS)
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: Hypotension with vasopressor requirement
timeFrame: 30 days
measure: Mortality
timeFrame: 45 days / 60 days / 90 days and 180 days
Other outcomes:
measure: Adverse events
timeFrame: 4 hours finished session
Locations:
city: San Isidro
country: Argentina
facility: Hospital Central de San Isidro Dr. Angel Melchor Posse
state: Buenos Aires
city: Ciudad Autonoma de Buenos AIres
country: Argentina
facility: Hospital de Infecciosas F. J. Muñiz
state: Caba
city: Ciudad Autonoma de Buenos AIres
country: Argentina
facility: Hospital General de Agudos D.F Santojanni
state: Caba
Study officials:
affiliation: Asociación Argentina de Medicina Hiperbárica e Investigación
name: Mariana Cannellotto, MD
role: STUDY_CHAIR
affiliation: Asociación Argentina de Medicina Hiperbárica e Investigación
name: Mariano Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Argentina de Medicina Hiperbárica e Investigación
name: Liliana Jorda-Vargas
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Argentina de Medicina Hiperbárica e Investigación
name: Fabrizio Verdini, MD
role: PRINCIPAL_INVESTIGATOR
References: