COVID, CoronavirusPhase 4HBOTNCT04409886
Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients
A Phase 4 study testing Hyperbaric Oxygen Therapy in people with COVID, Coronavirus, run by Maimonides Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Coronavirus
- What is being tested?
- Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to session
- One-hour session NBO/HBO
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
- One-hour session NBO/HBO (8 hours following the first session)
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Daily oxygen supply dose monitoring. Protocol Day 2-4
- 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.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
- 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.
- Daily oxygen supply dose monitoring. Follow up Protocol
- 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.
- Oropharyngeal swab for SARS-CoV-2 RT-PCR every 3 days for 1 week
- Clinical monitoring for 30 days
- Conditions
- COVID, Coronavirus
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyBiological
Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
| Study group | Role | What they receive |
|---|---|---|
| HBOT (Hyperbaric Oxygen Therapy) | Experimental | Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT) Receives: Biological: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index
PaO2/FiO2 (Oxygenation Index)
Measured: one day after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Why it stopped: This study is part of a larger national study. Only 1 patient was enrolled at Maimonides; Medical Center. The study was ended by the sponsor because the PI left; funding ended; , and no time, or personnel to do the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID, CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ory Wiesel, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409886
- Sponsor's protocol ID
- 120-20-ASF
- Acronym
- HBOT
- Status last verified
- Jun 2021
- First submitted
- 27 May 2020
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04409886
- Acronym / sponsor ID
- HBOT / 120-20-ASF
- Conditions
- COVID, Coronavirus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is part of a larger national study. Only 1 patient was enrolled at Maimonides; Medical Center. The study was ended by the sponsor because the PI left; funding ended; , and no time, or personnel to do the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to session
- One-hour session NBO/HBO
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
- One-hour session NBO/HBO (8 hours following the first session)
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Daily oxygen supply dose monitoring. Protocol Day 2-4
- 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.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
- 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.
- Daily oxygen supply dose monitoring. Follow up Protocol
- 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.
- Oropharyngeal swab for SARS-CoV-2 RT-PCR every 3 days for 1 week
- Clinical monitoring for 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOT (Hyperbaric Oxygen Therapy) | Experimental | Biological: Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT) | Biological | HBOT (Hyperbaric Oxygen Therapy) |
Primary outcome
Oxygenation Index
Time frame: one day after the last session
PaO2/FiO2 (Oxygenation Index)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ory Wiesel, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric Oxygen Therapy in people with COVID, Coronavirus, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (time frame: one day after the last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.