Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)

The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: COVID, Coronavirus
• Intervention / Treatment: Biological: Hyperbaric Oxygen Therapy

Detailed Description

This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients at MMC. The trial will include 30 patients who will undergo either HBOT or NBOT, randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others.

Sessions will be provided in an MMC monoplace HBO chamber (RestorixHealth). Since all patients demand oxygen supply at room air, the control group is an active arm receiving 100% oxygen. For HBOT, each session will include breathing 100% oxygen at 2.2 absolute atmospheres (ATA) for 60 minutes. Compression and decompression will occur at 1 meter/minute rate. For NBOT, each session will include breathing 100% oxygen at 1.0 absolute atmospheres (ATA) for 60 minutes. In order to blind the patient, the first 5 minutes will include compression for 1.1 ATA and then decompression to 1.0 within the next 5 minutes.

During the sessions, the symptoms and vitals will be monitored. The evaluation procedure will include 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. Sessions and evaluations procedures will occur as the following:

Protocol Day 1

1. Baseline evaluation: blood test including: arterial blood gases, 2 CBC tubes, 2 Gel tubes (10-15 cc total), vitals (temperature, blood pressure, heart rate, room air saturation), symptoms questionnaire, pulmonary function test.
2. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to session
3. One-hour session NBO/HBO
4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
5. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
6. One-hour session NBO/HBO (8 hours following the first session)
7. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
8. Daily oxygen supply dose monitoring. Protocol Day 2-4

1. Daily symptoms questionnaire 2. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to session One-hour session NBO/HBO 3. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.

4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.

5. One-hour session NBO/HBO (8 hours following the first session) 6. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.

7. Daily oxygen supply dose monitoring. Follow up Protocol

1. Repeat evaluations one day after the last session and one week after the last session:

   • Blood test including: arterial blood gases, 2 CBC tubes, 2 Gel tubes (10-15 cc total)
   • Vitals (temperature, blood pressure, heart rate, room air saturation)
   • Symptoms questionnaire
   • Pulmonary function test.
2. Oropharyngeal swab for SARS-CoV-2 RT-PCR every 3 days for 1 week
3. Clinical monitoring for 30 days

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBOT (Hyperbaric Oxygen Therapy); Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)	Biological: Hyperbaric Oxygen Therapy; Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation Index	PaO2/FiO2 (Oxygenation Index)	one day after the last session

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Investigators: Principal Investigator: Ory Wiesel, MD, Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: 120-20-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No