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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358926
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : November 3, 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study
Masking: Single (Outcomes Assessor)
Masking Description: 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
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : November 1, 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

No Intervention: Control
Standard of care



Primary Outcome Measures :
  1. PaO2/FiO2 [ Time Frame: 5 days after randomization ]
    Oxygenation index of the lungs calculated PaO2 measured in the blood divided by the inhaled FiO2

  2. SpO2 [ Time Frame: 5 days after randomization ]
    Oxygen saturation measured in % by oxygen apparatus

  3. NEWS Score [ Time Frame: 5 days after randomization ]
    Early Warning Score (NEWS) calculated by the patient's vitals and condition

  4. Inflammation level -CRP [ Time Frame: 5 days after randomization ]
    blood CRP level

  5. white blood cells number [ Time Frame: 5 days after randomization ]
    white blood cells number

  6. Cytokines - IL1 [ Time Frame: 5 days after randomization ]
    blood IL1 level

  7. Cytokines - IL2 [ Time Frame: 5 days after randomization ]
    blood IL2 level

  8. Cytokines - IL6 [ Time Frame: 5 days after randomization ]
    blood IL6 level

  9. Cytokines - IL10 [ Time Frame: 5 days after randomization ]
    blood IL10 level

  10. Cytokines - TNFalpha [ Time Frame: 5 days after randomization ]
    blood TNFalpha level

  11. Inflammation level - procalcitonin [ Time Frame: 5 days after randomization ]
    blood procalcitonin level

  12. Inflammation level - ferritin [ Time Frame: 5 days after randomization ]
    blood ferritin level


Secondary Outcome Measures :
  1. Symptoms level [ Time Frame: 5 days after randomization ]
    Patient's reported symptoms including cough, dyspnea, etc.

  2. Number of patients with IgM seroconversion [ Time Frame: 5 days after randomization ]
    number of patients who developed SARS-CoV-2 IgM antibodies

  3. Number of patients with IgG seroconversion [ Time Frame: 5 days after randomization ]
    number of patients who developed SARS-CoV-2 IgG antibodies

  4. FEV1/FVC [ Time Frame: 5 days after randomization ]
    Pulmonary function tests performed bedside

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

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

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

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

  9. Number of barotrauma events (safety) [ Time Frame: 5 days after randomization ]
    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


Locations
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Israel
Amir Hadanny
Zerifin, Israel
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: November 3, 2020
Last Verified: November 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