Ozone Auto-hemotherapy for COVID-19 Pneumonia

COVID-19 Pneumonia Clinical Trial

— COVID-OZONE  

Official title:

A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04370223
• Other study ID #: COVID-19 Networking group
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 25, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: June 2020
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Alberto Hernández, MD, PhD
• Phone: +34 637930993
• Email: albimar23[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: December 25, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Biological:
• Ozone auto-hemotherapy
ozone auto-hemotherapy

Locations

Country	Name	City	State
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Clinica Nuestra Senora del Rosario

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	14 days
Secondary	Mortality at day 28	mortality	28 days
Secondary	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)	28 days
Secondary	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)	7 days
Secondary	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)	28 days
Secondary	Number of ventilator-free days at 28 days	Ventilator-free days from last extubation day until day 28 after recruitment	28 days
Secondary	Hospital length of stay	Days hospitalized	28 days
Secondary	Time to a 2-fold decrease in ferritin	Number of days until a 2-fold decrease in ferritin (ng/mL)	14 days
Secondary	Time to a 2-fold decrease in C-protein reactive	Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)	14 days
Secondary	Time to a 2-fold decrease in Dimer-D	Number of days until a 2-fold decrease in Dimer-D (ng/mL)	14 days
Secondary	Time to a 2-fold decrease in Lactate Dehydrogenase	Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)	14 days
Secondary	Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio	Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio	14 days