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

• ClinicalTrials.gov Identifier: NCT04477954
• Recruitment Status: Terminated
• 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: July 16, 2020
• First Posted Date: July 20, 2020
• Last Update Posted Date: January 15, 2021
• Actual Study Start Date: July 6, 2020
• Actual Primary Completion Date: November 6, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
• Official Title: 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: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel Assignment

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Covid19

Intervention

Combination Product: Hyperbaric Oxygen

Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)

Other Name: HBOT

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 13, 2021): 40
• Original Estimated Enrollment (submitted: July 17, 2020): 80
• Actual Study Completion Date: December 30, 2020
• Actual Primary Completion Date: November 6, 2020 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT04477954
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación
• Original Responsible Party: Same as current
• Current Study Sponsor: Asociación Argentina de Medicina Hiperbárica e Investigación
• Original Study Sponsor: Same as current

Collaborators

• Hospital de Infecciosas Francisco Javier Muniz
• Hospital General de Agudos D. F. Santojanni
• Hospital Central de San Isidro Dr. Melchor Angel Posse

Investigators

• 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