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

• ClinicalTrials.gov Identifier: NCT04409886
• Recruitment Status: Terminated
• First Posted: June 1, 2020
• Results First Posted: June 29, 2021
• Last Update Posted: June 29, 2021
• Sponsor: Maimonides Medical Center
• Information provided by (Responsible Party): Maimonides Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID, Coronavirus	Biological: Hyperbaric Oxygen Therapy	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial
• Actual Study Start Date: June 1, 2020
• Actual Primary Completion Date: January 31, 2021
• Actual Study Completion Date: January 31, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Oxygenation Index [ Time Frame: one day after the last session ]
   PaO2/FiO2 (Oxygenation Index)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Maimonides Medical Center

Brooklyn, New York, United States, 11219

Sponsors and Collaborators

Maimonides Medical Center

Investigators

• Principal Investigator: Ory Wiesel, MD; Maimonides Medical Center

  Study Documents (Full-Text)

Documents provided by Maimonides Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2018

More Information

• Responsible Party: Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT04409886
• Other Study ID Numbers: 120-20-ASF
• First Posted: June 1, 2020
• Results First Posted: June 29, 2021
• Last Update Posted: June 29, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data will not be shared

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections