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

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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:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Combination Product: Hyperbaric Oxygen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
Actual Study Start Date : July 6, 2020
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental HBOT
Treatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen.
 Combination Product: Hyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Other Name: HBOT
No Intervention: Standard care


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) [ Time Frame: 30 days ]
    Number of patients who required IMV after being enrolled

  2. Development of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 30 days ]
    Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled.

  3. 30-day mortality [ Time Frame: 30 days ]
    Number of patients who died in that period since enrollment

  4. Hypotension with vasopressor requirement [ Time Frame: 30 days ]
    Number of patients with hypotension who were administered vasopressors in this period

  5. Mortality [ Time Frame: 45 days / 60 days / 90 days and 180 days ]
    Number of patients who died in that period since enrollment.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477954


Locations
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Argentina
Hospital Central de San Isidro Dr. Angel Melchor Posse
San Isidro, Buenos Aires, Argentina, 1641
Hospital de Infecciosas F. J. Muñiz
Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1282
Hospital General de Agudos D.F Santojanni
Ciudad Autonoma de Buenos AIres, Caba, Argentina, 1408
Sponsors and Collaborators
Asociación Argentina de Medicina Hiperbárica e Investigación
Hospital de Infecciosas Francisco Javier Muniz
Hospital General de Agudos D. F. Santojanni
Hospital Central de San Isidro Dr. Melchor Angel Posse
Investigators
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Study Chair: Mariana Cannellotto, MD Asociación Argentina de Medicina Hiperbárica e Investigación
Principal Investigator: Mariano Duarte, PhD Asociación Argentina de Medicina Hiperbárica e Investigación
Principal Investigator: Liliana Jorda-Vargas Asociación Argentina de Medicina Hiperbárica e Investigación
Principal Investigator: Fabrizio Verdini, MD Asociación Argentina de Medicina Hiperbárica e Investigación
More Information
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Responsible Party: Mariana Cannellotto, President, Asociación Argentina de Medicina Hiperbárica e Investigación
ClinicalTrials.gov Identifier: NCT04477954    
Other Study ID Numbers: AAMHEI2020-1
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación:
Hyperbaric Oxygen
Covid-19
Hypoxemia
Sars-CoV2
Hyperbaric Chamber
Additional relevant MeSH terms:
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COVID-19
Hypoxia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory