COVID-19 PneumoniaPhase 3COVID-OZONENCT04370223
Ozone Auto-hemotherapy for COVID-19 Pneumonia
A Phase 3 study testing Ozone auto-hemotherapy in people with COVID-19 Pneumonia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 10 sites in Spain.
Trial summary
This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia. Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Ozone auto-hemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 10 sitesSpain
- Study dates
- 25 May 2020to 25 Dec 2020
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COVID-19 confirmed by positive polymerase chain reaction (PCR) for Severe Acute Respiratory Syndrome (SARS-COV-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (SpO2) <94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (pO2/FiO2) ratio <300 mmHg or SpO2/FiO2 ≤ 315.
- Acceptance to participate in the study and signing of the informed consent.
Who cannot join
- Patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital.
- Patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy.
- Patients aware of having a deficiency of Glucose-6-phosphate dehydrogenase.
- Patients with clinically decompensated chronic comorbidities, independently of COVID-19.
- Patients suffering from any psychiatric disorder specified in axis I of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), other than major depression.
- Patients who are not able to clearly understand the objectives and methodology of the study.
- Pregnant or lactating patients.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitari Dr Josep Trueta
Girona, 17007
Clinica Nuestra Señora del Rosario
Ibiza Town
Hospital Quirón Rey Juan Carlos I
Madrid
Hospital Universitario 12 de Octubre
Madrid
Noelia Zurera Plaza, MD
Hospital Universitario Infanta Leonor
Madrid
Javier Ripolles, MD, PhD
Hospital Universitario Príncipe de Asturias de Alcalá de Henares
Madrid
Miguel Angel Garcia, MD
Fundació Althaia de Manresa
Manresa
Antònia Flor, MD
Hospital Vithas Valencia Consuelo
Valencia
Jose Baeza, MD
Hospital Clínico Universitario de Valladolid
Valladolid
Eduardo Tamayo, MD, PhD
Clinica Claro
Vigo
About this study
Official title: A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia.
Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone.
Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial.
All analyses will be done according to the intention-to-treat principle
- Conditions
- COVID-19 Pneumonia
- Being tested
- Ozone auto-hemotherapy
- Keywords
- Ozone therapy, Covid-19, SARS-COV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone auto-hemotherapyBiological
ozone auto-hemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Ozone auto-hemotherapy plus standard treatment | Experimental | Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Receives: Biological: Ozone auto-hemotherapy |
| Standard treatment alone | No intervention | Standard treatment will be the one used in each hospital participating in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Measured: 14 days
Secondary outcomes (11)
Mortality at day 28
mortality
Measured: 28 days
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Measured: 28 days
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Measured: 7 days
Time to clinical improvement or hospital discharge
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Measured: 28 days
Number of ventilator-free days at 28 days
Ventilator-free days from last extubation day until day 28 after recruitment
Measured: 28 days
Hospital length of stay
Days hospitalized
Measured: 28 days
Time to a 2-fold decrease in ferritin
Number of days until a 2-fold decrease in ferritin (ng/mL)
Measured: 14 days
Time to a 2-fold decrease in C-protein reactive
Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
Measured: 14 days
Time to a 2-fold decrease in Dimer-D
Number of days until a 2-fold decrease in Dimer-D (ng/mL)
Measured: 14 days
Time to a 2-fold decrease in Lactate Dehydrogenase
Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
Measured: 14 days
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start25 May 2020 (estimated)
- Primary completion25 Oct 2020 (estimated)
- Study completion25 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Nuestra Senora del Rosario
- Responsible party
- Principal investigator, Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370223
- Sponsor's protocol ID
- COVID-19 Networking group
- Acronym
- COVID-OZONE
- Status last verified
- Jun 2020
- First submitted
- 27 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04370223
- Acronym / sponsor ID
- COVID-OZONE / COVID-19 Networking group
- Conditions
- COVID-19 Pneumonia
- Keywords
- Ozone therapy, Covid-19, SARS-COV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- Clinica Nuestra Senora del Rosario
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 25 Oct 2020 (estimated)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 30 Apr 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.
This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia.
Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone.
Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial.
All analyses will be done according to the intention-to-treat principle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone auto-hemotherapy plus standard treatment | Experimental | Biological: Ozone auto-hemotherapyPatients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. |
| Standard treatment alone | No intervention | –Standard treatment will be the one used in each hospital participating in the trial. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of COVID-19 confirmed by positive polymerase chain reaction (PCR) for Severe Acute Respiratory Syndrome (SARS-COV-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (SpO2) <94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (pO2/FiO2) ratio <300 mmHg or SpO2/FiO2 ≤ 315.
- Acceptance to participate in the study and signing of the informed consent.
Key exclusion criteria (7 listed)
- Patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital.
- Patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy.
- Patients aware of having a deficiency of Glucose-6-phosphate dehydrogenase.
- Patients with clinically decompensated chronic comorbidities, independently of COVID-19.
- Patients suffering from any psychiatric disorder specified in axis I of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), other than major depression.
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 |
|---|---|---|
| Ozone auto-hemotherapyozone auto-hemotherapy | Biological | Ozone auto-hemotherapy plus standard treatment |
Primary outcome
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
Time frame: 14 days
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
11 secondary outcomes
Mortality at day 28
Time frame: 28 days
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
Time frame: 28 days
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
Time frame: 7 days
Time to clinical improvement or hospital discharge
Time frame: 28 days
Number of ventilator-free days at 28 days
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
Time to a 2-fold decrease in ferritin
Time frame: 14 days
Time to a 2-fold decrease in C-protein reactive
Time frame: 14 days
Time to a 2-fold decrease in Dimer-D
Time frame: 14 days
Time to a 2-fold decrease in Lactate Dehydrogenase
Time frame: 14 days
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozone auto-hemotherapy in people with COVID-19 Pneumonia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 10 sites in Spain.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Hernández, MD, PhD (+34 637930993, albimar23@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients achieving improvement in clinical condition at day 14 after recruitment (time frame: 14 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 9 Jun 2020.