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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477954 on ClinicalTrials.gov