NCT04358926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 21, 2026

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

April 21, 2020

Last Update Submit

April 16, 2026

Conditions

COVID-19Desaturation of Blood

Outcome Measures

Primary Outcomes (11)

  • SpO2

    Oxygen saturation measured in % by oxygen apparatus

    5 days after randomization

  • NEWS Score

    Early Warning Score (NEWS) calculated by the patient's vitals and condition

    5 days after randomization

  • Inflammation level -CRP

    blood CRP level

    5 days after randomization

  • white blood cells number

    white blood cells number

    5 days after randomization

  • Cytokines - IL1

    blood IL1 level

    5 days after randomization

  • Cytokines - IL2

    blood IL2 level

    5 days after randomization

  • Cytokines - IL6

    blood IL6 level

    5 days after randomization

  • Cytokines - IL10

    blood IL10 level

    5 days after randomization

  • Cytokines - TNFalpha

    blood TNFalpha level

    5 days after randomization

  • Inflammation level - procalcitonin

    blood procalcitonin level

    5 days after randomization

  • Inflammation level - ferritin

    blood ferritin level

    5 days after randomization

Secondary Outcomes (9)

  • Symptoms level

    5 days after randomization

  • Number of patients with IgM seroconversion

    5 days after randomization

  • Number of patients with IgG seroconversion

    5 days after randomization

  • FEV1/FVC

    5 days after randomization

  • Time to symptoms recovery

    Within 30 days

  • +4 more secondary outcomes

Study Arms (2)

Hyperbaric oxygen therapy

ACTIVE COMPARATOR

8 sessions in 4 days hyperbaric oxygen therapy

Device: Hyperbaric oxygen therapy

Control

NO INTERVENTION

Standard of care

Interventions

Hyperbaric oxygen therapyDEVICE

8 sessions in 4 days of breathing 100% oxygen in 2.2 ATA. Each session is 60 minutes. 1 meter/minute compression/decompression

Hyperbaric oxygen therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amir Hadanny

Ẕerifin, Israel

Location

Related Publications (5)

  • Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.

    PMID: 32200400BACKGROUND

  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578BACKGROUND

  • Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

    PMID: 32125452BACKGROUND

  • Rogatsky GG, Mayevsky A. The life-saving effect of hyperbaric oxygenation during early-phase severe blunt chest injuries. Undersea Hyperb Med. 2007 Mar-Apr;34(2):75-81.

    PMID: 17520858BACKGROUND

  • Weaver LK, Hopkins RO, Chan KJ, Churchill S, Elliott CG, Clemmer TP, Orme JF Jr, Thomas FO, Morris AH. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002 Oct 3;347(14):1057-67. doi: 10.1056/NEJMoa013121.

    PMID: 12362006BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Amir Hadanny, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessors will receive anonymous blinded data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

April 30, 2020

Primary Completion

October 15, 2020

Study Completion

November 1, 2020

Last Updated

April 21, 2026

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Sharing upon specific requests will be considered

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Within 1 month of request
Access Criteria
Specific requests

Locations

IL(1)