NCT04477954

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

Terminated Phase 2 Last updated 15 January 2021

What this trial tests

Phase 2 trial testing Hyperbaric Oxygen in Covid19 in 40 participants. Terminated before completion.

Timeline

6 July 2020

Primary endpoint
6 November 2020

30 December 2020

Quick facts

Lead sponsor	Asociación Argentina de Medicina Hiperbárica e Investigación
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	6 July 2020
Primary completion	6 November 2020
Estimated completion	30 December 2020
Sites	3 locations across Argentina

Drugs / interventions tested

• Hyperbaric Oxygen — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Asociación Argentina de Medicina Hiperbárica e Investigación

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial.
   Cannellotto M, Duarte M, Keller G, Larrea R, et al · · 2022 · cited 18× · PMID 34907003 · DOI 10.1136/emermed-2021-211253