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
Biological: Ozone auto-hemotherapy
ozone auto-hemotherapy
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.
Hospital Universitari Dr Josep Trueta
Girona, Spain
Clinica Nuestra Señora del Rosario
Ibiza, Spain
Hospital Quirón Rey Juan Carlos I
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Príncipe de Asturias de Alcalá de Henares
Madrid, Spain
Fundació Althaia de Manresa
Manresa, Spain
Hospital Vithas Valencia Consuelo
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Clinica Claro
Vigo, Spain
Alberto Hernández, MD, PhD
+34 637930993
albimar23@yahoo.es
Marc Vives, MD, PhD
+34 690277088
marcvives50@gmail.com