Trial | NCT04370223  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    208
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
Study Started
May 25
2020
Anticipated
Primary Completion
Oct 25
2020
Anticipated
Study Completion
Dec 25
2020
Anticipated
Last Update
Jun 09
2020

Biological Ozone auto-hemotherapy

ozone auto-hemotherapy

Ozone auto-hemotherapy plus standard treatment Experimental

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 alone No Intervention

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

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.
No Results Posted