Covid19Phase 2NCT04477954
Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
A Phase 2 study testing Hyperbaric Oxygen in people with Covid19, run by Asociación Argentina de Medicina Hiperbárica e Investigación at 3 sites in Argentina.
Trial summary
The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hyperbaric Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesArgentina
- Study dates
- 6 Jul 2020to 30 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18 years, all sexes.
- No previous hospitalizations in the last 6 months.
- Positive diagnostic test for COVID-19 according to the guidelines of the Argetine Ministry of Health at the time of enrollment.
- Patient in Intensive Care Unit with oxygen need: Need for continuous supply of oxygen to maintain saturation by oximetry pulse (SpO2) greater than or equal to 93% or arterial gas with PaO2 value greater than 60 mmHg
Who cannot join
- 18 years of age.
- Person unable to give consent.
- Person who refuses to participate.
- Pregnancy and lactation
- Participating in other study
- Requirement for mechanical ventilation.
- Inability to maintain prolonged sitting position (at least 2 hours)
- Subject with contraindications to HBOT (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade III or IV).
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Hospital de Infecciosas F. J. Muñiz
Buenos Aires, Buenos Aires F.D., 1282
Hospital General de Agudos D.F Santojanni
Buenos Aires, Buenos Aires F.D., 1408
Hospital Central de San Isidro Dr. Angel Melchor Posse
San Isidro, Buenos Aires, 1641
About this study
The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.
- Conditions
- Covid19
- Being tested
- Hyperbaric Oxygen
- Keywords
- Hyperbaric Oxygen, Covid-19, Hypoxemia, Sars-CoV2, Hyperbaric Chamber
- Medical subject headings
- COVID-19, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenCombination product
Also called HBOT
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
| Study group | Role | What they receive |
|---|---|---|
| Experimental HBOT | Experimental | Treatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen. Receives: Combination Product: Hyperbaric Oxygen |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to normalize the oxygen requirement (oxygen dependence)
Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air.
Measured: 15-30 days.
Secondary outcomes (5)
Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)
Number of patients who required IMV after being enrolled
Measured: 30 days
Development of Acute Respiratory Distress Syndrome (ARDS)
Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled.
Measured: 30 days
30-day mortality
Number of patients who died in that period since enrollment
Measured: 30 days
Hypotension with vasopressor requirement
Number of patients with hypotension who were administered vasopressors in this period
Measured: 30 days
Mortality
Number of patients who died in that period since enrollment.
Measured: 45 days / 60 days / 90 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start6 Jul 2020
- Primary completion6 Nov 2020
- Study completion30 Dec 2020
Why it stopped: Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Argentina de Medicina Hiperbárica e Investigación
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Infecciosas Francisco Javier Muniz, Hospital General de Agudos D. F. Santojanni, Hospital Central de San Isidro Dr. Melchor Angel Posse
- Responsible party
- Principal investigator, Mariana Cannellotto, Asociación Argentina de Medicina Hiperbárica e Investigación
- Investigators
- Mariana Cannellotto, MD, Study chair, Asociación Argentina de Medicina Hiperbárica e InvestigaciónMariano Duarte, PhD, Principal investigator, Asociación Argentina de Medicina Hiperbárica e InvestigaciónLiliana Jorda-Vargas, Principal investigator, Asociación Argentina de Medicina Hiperbárica e InvestigaciónFabrizio Verdini, MD, Principal investigator, Asociación Argentina de Medicina Hiperbárica e Investigación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477954
- Sponsor's protocol ID
- AAMHEI2020-1
- Status last verified
- Jan 2021
- First submitted
- 16 Jul 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
- ClinicalTrials.gov ID
- NCT04477954
- Acronym / sponsor ID
- AAMHEI2020-1
- Conditions
- Covid19
- Keywords
- Hyperbaric Oxygen, Covid-19, Hypoxemia, Sars-CoV2, Hyperbaric Chamber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asociación Argentina de Medicina Hiperbárica e InvestigaciónUniversity, hospital or other
- Collaborators
- Hospital de Infecciosas Francisco Javier Muniz, Hospital General de Agudos D. F. Santojanni, Hospital Central de San Isidro Dr. Melchor Angel Posse
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental HBOT | Experimental | Combination Product: Hyperbaric OxygenTreatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen. |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years, all sexes.
- No previous hospitalizations in the last 6 months.
- Positive diagnostic test for COVID-19 according to the guidelines of the Argetine Ministry of Health at the time of enrollment.
- Patient in Intensive Care Unit with oxygen need: Need for continuous supply of oxygen to maintain saturation by oximetry pulse (SpO2) greater than or equal to 93% or arterial gas with PaO2 value greater than 60 mmHg
Key exclusion criteria (8 listed)
- 18 years of age.
- Person unable to give consent.
- Person who refuses to participate.
- Pregnancy and lactation
- Participating in other study
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 OxygenAlso: HBOTHyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430) | Combination product | Experimental HBOT |
Primary outcome
Time to normalize the oxygen requirement (oxygen dependence)
Time frame: 15-30 days.
Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air.
5 secondary outcomes
Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)
Time frame: 30 days
Development of Acute Respiratory Distress Syndrome (ARDS)
Time frame: 30 days
30-day mortality
Time frame: 30 days
Hypotension with vasopressor requirement
Time frame: 30 days
Mortality
Time frame: 45 days / 60 days / 90 days and 180 days
Results and safety
The study was stopped early (reason given: Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Mariana Cannellotto, MD study chair
Asociación Argentina de Medicina Hiperbárica e Investigación
Mariano Duarte, PhD principal investigator
Asociación Argentina de Medicina Hiperbárica e Investigación
Liliana Jorda-Vargas principal investigator
Asociación Argentina de Medicina Hiperbárica e Investigación
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen in people with Covid19, run by Asociación Argentina de Medicina Hiperbárica e Investigación at 3 sites in Argentina.
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 4 inclusion and 8 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.). Results are not available in the source record.
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?
Time to normalize the oxygen requirement (oxygen dependence) (time frame: 15-30 days.). 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 15 Jan 2021.