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Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409886
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center

Brief Summary:

This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others.

The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.


Condition or disease Intervention/treatment Phase
COVID, Coronavirus Device: Hyperbaric Chamber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: HBOT (Hyperbaric Oxygen Therapy) Device: Hyperbaric Chamber
Dives in a Hyperbaric Oxygen chamber

Experimental: NBOT (Normobaric Oxygen Therapy) Device: Hyperbaric Chamber
Dives in a Hyperbaric Oxygen chamber




Primary Outcome Measures :
  1. Oxygenation index [ Time Frame: one day after the last session ]
    PaO2/FiO2

  2. SpO2 [ Time Frame: 6 hours after a session ]
    Room air saturation


Secondary Outcome Measures :
  1. SpO2 [ Time Frame: one week after the last session ]
    Room air saturation

  2. Symptoms level [ Time Frame: one week after the last session ]
    COVID19 symptoms

  3. Chest Xray [ Time Frame: one week after the last session ]
    Radiologic



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Within 7 days of patient's need of oxygen supply
  • Positive SARS-CoV-2 RT-PCR
  • At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes mellitus, ischemic heart disease, smoking, age>50, etc.
  • Respiratory insufficiency: Room Air SpO2 <94% or PaO2/FiO2<300mmHg
  • Age>18
  • Ability to sign an informed consent

Exclusion Criteria:

  • Negative SARS-CoV-2 RT-PCR
  • HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus disease which aren't allowed in HBOT, known chronic pulmonary disease: severe emphysema or known pulmonary bullae.
  • Pregnancy
  • Inability to sign an informed consent

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): NCT04409886


Contacts
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Contact: Ory Wiesel, MD 718-283-7936 owiesel@maimonidesmed.org
Contact: Gene Sobol 718-283-2926 gsobol@maimonidesmed.org

Sponsors and Collaborators
Maimonides Medical Center
Investigators
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Principal Investigator: Ory Wiesel, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Maimonides Medical Center:
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Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT04409886    
Other Study ID Numbers: 120-20-ASF
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases