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Trial record 5 of 7 for:    hyperbaric covid

Hyperbaric Oxygen Therapy Effect in COVID-19 RCT (HBOTCOVID19) (HBOTCOVID19)

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: NCT04358926
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:

The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic.So far, no specific treatment has proven efficacy. Recent case series reported the use of Hyperbaric Oxygen Therapy (HBOT) on 5 severe COVID-19 patients who developed respiratory insufficiency. HBOT mechanisms of tissue oxygenation and anti-inflammatory effect may explain these findings.

The purpose of the current study is the evaluate the efficacy of HBOT in moderate-severe COVID-19 patients in a randomized controlled manner.


Condition or disease Intervention/treatment Phase
COVID-19 Desaturation of Blood Device: Hyperbaric oxygen therapy Device: Normobaric oxygen therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controled, double blinded study
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The participants will be be able to tell if treated by hyperbaric or normobaric oxygen being in the chamber, blinded to the measured pressure.

The outcome assessors will receive anonymous blinded data.

Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy Effect in COVID-19 RCT (HBOTCOVID19)
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Hyperbaric oxygen therapy
8 sessions in 4 days hyperbaric oxygen therapy
Device: Hyperbaric oxygen therapy
8 sessions in 4 days of breathing 100% oxygen in 2.2 ATA. Each session is 60 minutes. 1 meter/minute compression/decompression

Active Comparator: Normobaric oxygen therapy
8 sessions in 4 days of normobaric oxygen therapy
Device: Normobaric oxygen therapy
8 sessions in 4 days of breathing 100% oxygen in 1.0 ATA. Each session is 60 minutes. During the first 5 minutes compression would be performed to 1.1 ATA in 0.2meter/minute and then decompressed to 1.0 in the next 5 minutes.




Primary Outcome Measures :
  1. PaO2/FiO2 [ Time Frame: 1 day and 7 days after the last intervention session ]
    Oxygenation index of the lungs calculated PaO2 measured in the blood divided by the inhaled FiO2

  2. SpO2 [ Time Frame: One hour prior to and after every intervention session, 1 day and 7 days after the last intervention session ]
    Oxygen saturation measured in %

  3. NEWS Score [ Time Frame: One hour prior to and after every intervention session, 1 day and 7 days after the last intervention session ]
    Early Warning Score (NEWS) calculated by the patient's vitals and condition

  4. Inflammation level -CRP [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood CRP level

  5. Inflammation level - ESR [ Time Frame: 1 day and 7 days after the last intervention session ]
    erythrocyte sedimentation rate

  6. white blood cells number [ Time Frame: 1 day and 7 days after the last intervention session ]
    white blood cells number

  7. Cytokines - IL1 [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood IL1 level

  8. Cytokines - IL2 [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood IL2 level

  9. Cytokines - IL6 [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood IL6 level

  10. Cytokines - IL10 [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood IL10 level

  11. Cytokines - TNFalpha [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood TNFalpha level

  12. Inflammation level - procalcitonin [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood procalcitonin level

  13. Inflammation level - ferritin [ Time Frame: 1 day and 7 days after the last intervention session ]
    blood ferritin level


Secondary Outcome Measures :
  1. Symptoms level [ Time Frame: 1 day and 7 days after the last intervention session ]
    Patient's reported symptoms including cough, dyspnea, etc.

  2. Average oxygen supply per day [ Time Frame: 1 day and 7 days after the last intervention session ]
    Oxygen amount supplied measured in IU

  3. Viral load [ Time Frame: 1 day and 7 days after the last intervention session ]
    Quantitative measurement of viral load in the blood using quantitative RT-PCR

  4. Chest Xray changes [ Time Frame: 1 day and 7 days after the last intervention session ]
    Chest xray changes evaluated qualitatively and quantitatively

  5. Number of patients with IgG seroconversion [ Time Frame: 1 day and 7 days after the last intervention session ]
    number of patients who developed SARS-CoV-2 IgG antibodies

  6. Number of patients with IgM seroconversion [ Time Frame: 1 day and 7 days after the last intervention session ]
    number of patients who developed SARS-CoV-2 IgM antibodies

  7. FEV1/FVC [ Time Frame: 1 day and 7 days after the last intervention session ]
    Pulmonary function tests performed bedside

  8. Time to symptoms recovery [ Time Frame: Within 30 days ]
    The measured time the patient suffered symptoms until complete recovery

  9. Number of patients who required invasive ventilation [ Time Frame: Within 30 days ]
    The number of patients who required invasive ventilation during the trial

  10. Time to negative virus PCR [ Time Frame: Within 30 days ]
    The measured time until the patient had two negative SARS-CoV-2 PCR

  11. Mortality rate [ Time Frame: Within 30 days ]
    The number of patients who died

  12. Number of barotrauma events (safety) [ Time Frame: Within 7 days after the last session ]
    The number of adverse events in each arm



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: Moderate-severe Asthma, Diabetes mellitus, Cardiac conditions (congestive heart failure, coronary disease, cardiomyopathy, pulmonary hypertension), severe obesity (BMI>40), age>65, immunodeficiency, chronic liver disease.
  • Respiratory insufficiency : Room Air SpO2 <94% or PaO2/FiO2<300mmHg
  • Age>18
  • Ability to sign an informed consent

Exclusion Criteria:

  • 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): NCT04358926


Contacts
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Contact: Amir Hadanny, MD 972544707381 amir.had@gmail.com
Contact: Shai Efrati, MD efratishai@outlook.com

Locations
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Israel
Amir Hadanny Recruiting
Zerifin, Israel
Contact: Amir Hadanny, MD         
Principal Investigator: Amir Hadanny, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Amir Hadanny, MD Shamir Medical Center
Publications:
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT04358926    
Other Study ID Numbers: 120-20-ASF
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing upon specific requests will be considered
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within 1 month of request
Access Criteria: Specific requests

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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