Status:
COMPLETED
Hyperbaric Oxygen Therapy Effect in COVID-19 RCT (HBOTCOVID19)
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
COVID-19
Desaturation of Blood
Eligibility:
All Genders
18+ years
Phase:
NA
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) o...
Detailed Description
The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic. The outbreak started in Wuhan, Hubei province, China, in December 2019 and the World Health Organization (WHO) recognized i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04358926
Start Date
April 30 2020
End Date
November 1 2020
Last Update
February 3 2021
Active Locations (1)
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1
Amir Hadanny
Ẕerifin, Israel