- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370223
Ozone Auto-hemotherapy for COVID-19 Pneumonia (COVID-OZONE)
A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Alberto Hernández, MD, PhD
- Phone Number: +34 637930993
- Email: albimar23@yahoo.es
Study Contact Backup
- Name: Marc Vives, MD, PhD
- Phone Number: +34 690277088
- Email: marcvives50@gmail.com
Study Locations
-
-
-
Girona, Spain, 17007
- Hospital Universitari Dr Josep Trueta
-
Ibiza, Spain
- Clinica Nuestra Señora del Rosario
-
Madrid, Spain
- Hospital Universitario 12 de Octubre
-
Contact:
- Noelia Zurera Plaza, MD
-
Madrid, Spain
- Hospital Universitario Infanta Leonor
-
Contact:
- Javier Ripolles, MD, PhD
-
Madrid, Spain
- Hospital Quirón Rey Juan Carlos I
-
Madrid, Spain
- Hospital Universitario Príncipe de Asturias de Alcalá de Henares
-
Contact:
- Miguel Angel Garcia, MD
-
Manresa, Spain
- Fundació Althaia de Manresa
-
Contact:
- Antònia Flor, MD
-
Valencia, Spain
- Hospital Vithas Valencia Consuelo
-
Contact:
- Jose Baeza, MD
-
Valladolid, Spain
- Hospital Clínico Universitario de Valladolid
-
Contact:
- Eduardo Tamayo, MD, PhD
-
Vigo, Spain
- Clinica Claro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
ozone auto-hemotherapy
|
No Intervention: Standard treatment alone
Standard treatment will be the one used in each hospital participating in the trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
Time Frame: 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)
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality at day 28
Time Frame: 28 days
|
mortality
|
28 days
|
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
Time Frame: 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)
|
28 days
|
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
Time Frame: 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)
|
7 days
|
Time to clinical improvement or hospital discharge
Time Frame: 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)
|
28 days
|
Number of ventilator-free days at 28 days
Time Frame: 28 days
|
Ventilator-free days from last extubation day until day 28 after recruitment
|
28 days
|
Hospital length of stay
Time Frame: 28 days
|
Days hospitalized
|
28 days
|
Time to a 2-fold decrease in ferritin
Time Frame: 14 days
|
Number of days until a 2-fold decrease in ferritin (ng/mL)
|
14 days
|
Time to a 2-fold decrease in C-protein reactive
Time Frame: 14 days
|
Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
|
14 days
|
Time to a 2-fold decrease in Dimer-D
Time Frame: 14 days
|
Number of days until a 2-fold decrease in Dimer-D (ng/mL)
|
14 days
|
Time to a 2-fold decrease in Lactate Dehydrogenase
Time Frame: 14 days
|
Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
|
14 days
|
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Time Frame: 14 days
|
Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio
|
14 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19 Networking group
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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