Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients

Stopped early · Phase 4

Conditions studied: COVID, Coronavirus

In brief

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.

Key facts

Study ID

NCT04409886

Run by

Maimonides Medical Center

People needed

1

Starts

2020-06-01

Expected to finish

2021-01-31

Last updated by the study team

2021-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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: 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

You may not qualify if…

• 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

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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