Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
NCT04477954 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-01-15
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
Interventions
- COMBINATION_PRODUCT
-
Hyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Sponsors & Collaborators
-
Hospital de Infecciosas Francisco Javier Muniz
collaborator OTHER_GOV -
Hospital General de Agudos D. F. Santojanni
collaborator UNKNOWN -
Hospital Central de San Isidro Dr. Melchor Angel Posse
collaborator UNKNOWN -
Asociación Argentina de Medicina Hiperbárica e Investigación
lead OTHER
Principal Investigators
-
Mariana Cannellotto, MD · Asociación Argentina de Medicina Hiperbárica e Investigación
-
Mariano Duarte, PhD · Asociación Argentina de Medicina Hiperbárica e Investigación
-
Liliana Jorda-Vargas · Asociación Argentina de Medicina Hiperbárica e Investigación
-
Fabrizio Verdini, MD · Asociación Argentina de Medicina Hiperbárica e Investigación
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-06
- Primary Completion
- 2020-11-06
- Completion
- 2020-12-30
Countries
- Argentina
Study Locations
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