Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04477954 |
Recruitment Status :
Terminated
(Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.)
First Posted : July 20, 2020
Last Update Posted : January 15, 2021
|
Sponsor:
Asociación Argentina de Medicina Hiperbárica e Investigación
Collaborators:
Hospital de Infecciosas Francisco Javier Muniz
Hospital General de Agudos D. F. Santojanni
Hospital Central de San Isidro Dr. Melchor Angel Posse
Information provided by (Responsible Party):
Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | July 16, 2020 | ||||||||||||
First Posted Date ICMJE | July 20, 2020 | ||||||||||||
Last Update Posted Date | January 15, 2021 | ||||||||||||
Actual Study Start Date ICMJE | July 6, 2020 | ||||||||||||
Actual Primary Completion Date | November 6, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Time to normalize the oxygen requirement (oxygen dependence) [ Time Frame: 15-30 days. ] 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.
|
||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Pre-specified Outcome Measures |
Adverse events [ Time Frame: 4 hours finished session ] 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
|
||||||||||||
Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia | ||||||||||||
Official Title ICMJE | Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia | ||||||||||||
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. | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel Assignment Masking: None (Open Label)Primary Purpose: Treatment |
||||||||||||
Condition ICMJE | Covid19 | ||||||||||||
Intervention ICMJE | Combination Product: Hyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Other Name: HBOT
|
||||||||||||
Study Arms ICMJE |
|
||||||||||||
Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||
Actual Enrollment ICMJE |
40 | ||||||||||||
Original Estimated Enrollment ICMJE |
80 | ||||||||||||
Actual Study Completion Date ICMJE | December 30, 2020 | ||||||||||||
Actual Primary Completion Date | November 6, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
Sex/Gender ICMJE |
|
||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Argentina | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04477954 | ||||||||||||
Other Study ID Numbers ICMJE | AAMHEI2020-1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||
Current Responsible Party | Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor ICMJE | Asociación Argentina de Medicina Hiperbárica e Investigación | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE |
|
||||||||||||
Investigators ICMJE |
|
||||||||||||
PRS Account | Asociación Argentina de Medicina Hiperbárica e Investigación | ||||||||||||
Verification Date | January 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |