Ozone Auto-hemotherapy for COVID-19 Pneumonia
COVID-OZONE
A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
1 other identifier
interventional
208
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2020
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedStudy Start
First participant enrolled
May 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2020
CompletedJune 9, 2020
June 1, 2020
5 months
April 27, 2020
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Mortality at day 28
28 days
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
28 days
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
7 days
Time to clinical improvement or hospital discharge
28 days
Number of ventilator-free days at 28 days
28 days
- +6 more secondary outcomes
Study Arms (2)
Ozone auto-hemotherapy plus standard treatment
EXPERIMENTALPatients 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 INTERVENTIONStandard treatment will be the one used in each hospital participating in the trial.
Interventions
ozone auto-hemotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Hospital Universitari Dr Josep Trueta
Girona, 17007, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 30, 2020
Study Start
May 25, 2020
Primary Completion
October 25, 2020
Study Completion
December 25, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share