Ozone Auto-hemotherapy for COVID-19 Pneumonia

Phase 3

• Conditions: COVID-19 Pneumonia
• Interventions: Biological: Ozone auto-hemotherapy

• Registration Number: NCT04370223
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief 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.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Study Start: 2020-05-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-10-25
• Study Completion: 2020-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone auto-hemotherapy plus standard treatment	Ozone auto-hemotherapy	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.

Primary Outcome Measures

Name	Time	Method
Rate of patients achieving improvement in clinical condition at day 14 after recruitment	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)

Secondary Outcome Measures

Name	Time	Method
Time to clinical improvement or hospital discharge	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)
Time to a 2-fold decrease in Lactate Dehydrogenase	14 days	Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
Time to a 2-fold decrease in ferritin	14 days	Number of days until a 2-fold decrease in ferritin (ng/mL)
Time to a 2-fold decrease in C-protein reactive	14 days	Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
Number of ventilator-free days at 28 days	28 days	Ventilator-free days from last extubation day until day 28 after recruitment
Hospital length of stay	28 days	Days hospitalized
Rate of patients achieving improvement in clinical condition at day 28 after recruitment	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	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 a 2-fold decrease in Dimer-D	14 days	Number of days until a 2-fold decrease in Dimer-D (ng/mL)
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio	14 days	Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio
Mortality at day 28	28 days	mortality

Trial Locations

Locations (10)

Hospital Quirón Rey Juan Carlos I; 🇪🇸 Madrid, Spain

Hospital Universitario Príncipe de Asturias de Alcalá de Henares; 🇪🇸 Madrid, Spain

Clinica Claro; 🇪🇸 Vigo, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Clinica Nuestra Señora del Rosario; 🇪🇸 Ibiza, Spain

Hospital Universitari Dr Josep Trueta; 🇪🇸 Girona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Fundació Althaia de Manresa; 🇪🇸 Manresa, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Vithas Valencia Consuelo; 🇪🇸 Valencia, Spain