Ozone Auto-hemotherapy for COVID-19 Pneumonia (COVID-OZONE)
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ClinicalTrials.gov Identifier: NCT04370223 |
Recruitment Status : Unknown
Verified June 2020 by Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.
Recruitment status was: Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : June 9, 2020
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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
Condition or disease | Intervention/treatment | Phase |
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COVID-19 Pneumonia | Biological: Ozone auto-hemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 208 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia |
Estimated Study Start Date : | May 25, 2020 |
Estimated Primary Completion Date : | October 25, 2020 |
Estimated Study Completion Date : | December 25, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Ozone auto-hemotherapy plus standard treatment
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.
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Biological: Ozone auto-hemotherapy
ozone auto-hemotherapy |
No Intervention: Standard treatment alone
Standard treatment will be the one used in each hospital participating in the trial.
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- 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)
- Mortality at day 28 [ Time Frame: 28 days ]mortality
- Rate of patients achieving improvement in clinical condition at day 28 after recruitment [ Time Frame: 28 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)
- Rate of patients achieving improvement in clinical condition at day 7 after recruitment [ Time Frame: 7 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)
- Time to clinical improvement or hospital discharge [ Time Frame: 28 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)
- Number of ventilator-free days at 28 days [ Time Frame: 28 days ]Ventilator-free days from last extubation day until day 28 after recruitment
- Hospital length of stay [ Time Frame: 28 days ]Days hospitalized
- Time to a 2-fold decrease in ferritin [ Time Frame: 14 days ]Number of days until a 2-fold decrease in ferritin (ng/mL)
- Time to a 2-fold decrease in C-protein reactive [ Time Frame: 14 days ]Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
- Time to a 2-fold decrease in Dimer-D [ Time Frame: 14 days ]Number of days until a 2-fold decrease in Dimer-D (ng/mL)
- Time to a 2-fold decrease in Lactate Dehydrogenase [ Time Frame: 14 days ]Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
- Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio [ Time Frame: 14 days ]Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370223
Contact: Alberto Hernández, MD, PhD | +34 637930993 | albimar23@yahoo.es | |
Contact: Marc Vives, MD, PhD | +34 690277088 | marcvives50@gmail.com |
Spain | |
Hospital Universitari Dr Josep Trueta | |
Girona, Spain, 17007 | |
Clinica Nuestra Señora del Rosario | |
Ibiza, Spain | |
Hospital Quirón Rey Juan Carlos I | |
Madrid, Spain | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain | |
Contact: Noelia Zurera Plaza, MD | |
Hospital Universitario Infanta Leonor | |
Madrid, Spain | |
Contact: Javier Ripolles, MD, PhD | |
Hospital Universitario Príncipe de Asturias de Alcalá de Henares | |
Madrid, Spain | |
Contact: Miguel Angel Garcia, MD | |
Fundació Althaia de Manresa | |
Manresa, Spain | |
Contact: Antònia Flor, MD | |
Hospital Vithas Valencia Consuelo | |
Valencia, Spain | |
Contact: Jose Baeza, MD | |
Hospital Clínico Universitario de Valladolid | |
Valladolid, Spain | |
Contact: Eduardo Tamayo, MD, PhD | |
Clinica Claro | |
Vigo, Spain |
Responsible Party: | Marc Vives, MD, PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
ClinicalTrials.gov Identifier: | NCT04370223 |
Other Study ID Numbers: |
COVID-19 Networking group |
First Posted: | April 30, 2020 Key Record Dates |
Last Update Posted: | June 9, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ozone therapy Covid-19 SARS-COV-2 |
COVID-19 Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |