Ozone Auto-hemotherapy for COVID-19 Pneumonia

NCT ID: NCT04370223

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2020-12-25

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

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ozone auto-hemotherapy

Intervention Type: BIOLOGICAL

ozone auto-hemotherapy

Standard treatment alone

Standard treatment will be the one used in each hospital participating in the trial.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ozone auto-hemotherapy

ozone auto-hemotherapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Nuestra Senora del Rosario

OTHER

Sponsor Role: collaborator

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role: lead

Responsible Party

Marc Vives

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitari Dr Josep Trueta

Girona, , Spain

Clinica Nuestra Señora del Rosario

Ibiza Town, , 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

Countries

Spain

Central Contacts

Alberto Hernández, MD, PhD

Role: CONTACT

albimar23@yahoo.es

+34 637930993

Marc Vives, MD, PhD

Role: CONTACT

marcvives50@gmail.com

+34 690277088

Facility Contacts

Noelia Zurera Plaza, MD

Role: primary

Javier Ripolles, MD, PhD

Role: primary

Miguel Angel Garcia, MD

Role: primary

Antònia Flor, MD

Role: primary

Jose Baeza, MD

Role: primary

Eduardo Tamayo, MD, PhD

Role: primary

Other Identifiers

COVID-19 Networking group

Identifier Type: -

Identifier Source: org_study_id