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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:
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
 (submitted: July 17, 2020)
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
 (submitted: July 17, 2020)
  • 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
  • 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.
  • 30-day mortality [ Time Frame: 30 days ]
    Number of patients who died in that period since enrollment
  • Hypotension with vasopressor requirement [ Time Frame: 30 days ]
    Number of patients with hypotension who were administered vasopressors in this period
  • Mortality [ Time Frame: 45 days / 60 days / 90 days and 180 days ]
    Number of patients who died in that period since enrollment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2020)
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
  • 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.
    Intervention: Combination Product: Hyperbaric Oxygen
  • No Intervention: Standard care
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
 (submitted: January 13, 2021)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2020)
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:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación
Study Sponsor  ICMJE Asociación Argentina de Medicina Hiperbárica e Investigación
Collaborators  ICMJE
  • Hospital de Infecciosas Francisco Javier Muniz
  • Hospital General de Agudos D. F. Santojanni
  • Hospital Central de San Isidro Dr. Melchor Angel Posse
Investigators  ICMJE
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
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