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Ozone Auto-hemotherapy for COVID-19 Pneumonia (COVID-OZONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370223
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Clinica Nuestra Senora del Rosario
Information provided by (Responsible Party):
Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Biological: Ozone auto-hemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : October 25, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone Pneumonia

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.
Biological: Ozone auto-hemotherapy
ozone auto-hemotherapy

No Intervention: Standard treatment alone
Standard treatment will be the one used in each hospital participating in the trial.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Mortality at day 28 [ Time Frame: 28 days ]
    mortality

  2. 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)

  3. 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)

  4. 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)

  5. Number of ventilator-free days at 28 days [ Time Frame: 28 days ]
    Ventilator-free days from last extubation day until day 28 after recruitment

  6. Hospital length of stay [ Time Frame: 28 days ]
    Days hospitalized

  7. Time to a 2-fold decrease in ferritin [ Time Frame: 14 days ]
    Number of days until a 2-fold decrease in ferritin (ng/mL)

  8. 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)

  9. 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)

  10. 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)

  11. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370223


Contacts
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Contact: Alberto Hernández, MD, PhD +34 637930993 albimar23@yahoo.es
Contact: Marc Vives, MD, PhD +34 690277088 marcvives50@gmail.com

Locations
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Spain
Hospital Universitari Dr Josep Trueta
Girona, Spain, 17007
Clinica Nuestra Señora del Rosario
Ibiza, Spain
Hospital Quirón Rey Juan Carlos I
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Contact: Noelia Zurera Plaza, MD         
Hospital Universitario Infanta Leonor
Madrid, Spain
Contact: Javier Ripolles, MD, PhD         
Hospital Universitario Príncipe de Asturias de Alcalá de Henares
Madrid, Spain
Contact: Miguel Angel Garcia, MD         
Fundació Althaia de Manresa
Manresa, Spain
Contact: Antònia Flor, MD         
Hospital Vithas Valencia Consuelo
Valencia, Spain
Contact: Jose Baeza, MD         
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Contact: Eduardo Tamayo, MD, PhD         
Clinica Claro
Vigo, Spain
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Clinica Nuestra Senora del Rosario
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Responsible Party: Marc Vives, MD, PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT04370223    
Other Study ID Numbers: COVID-19 Networking group
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
Ozone therapy
Covid-19
SARS-COV-2
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections