Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04409886 |
| Other study ID # |
120-20-ASF |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
