Dr. Ory Wiesel of Maimonides Medical Center in Brooklyn, NY has begun a new clinical trial to study COVID-19 patients treated with Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT).
Brief Summary:
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.
Interventions:
- Experimental: HBOT (Hyperbaric Oxygen Therapy) Dives in a Hyperbaric Oxygen chamber
- Experimental: NBOT (Normobaric Oxygen Therapy) Dives in a Hyperbaric Oxygen chamber
Primary Outcome Measures :
- Oxygenation index [ Time Frame: one day after the last session ] PaO2/FiO2
- SpO2 [ Time Frame: 6 hours after a session ] Room air saturation
Secondary Outcome Measures:
- SpO2 [ Time Frame: one week after the last session ] Room air saturation
- Symptoms level [ Time Frame: one week after the last session ] COVID19 symptoms
- Chest Xray [ Time Frame: one week after the last session ] Radiologic
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: 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
Exclusion Criteria:
- 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
Read the full study: https://clinicaltrials.gov/ct2/show/NCT04409886