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

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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

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date June 9, 2020
Estimated Study Start Date  ICMJE May 25, 2020
Estimated Primary Completion Date October 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Mortality at day 28 [ Time Frame: 28 days ]
    mortality
  • 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)
  • 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)
  • 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)
  • Number of ventilator-free days at 28 days [ Time Frame: 28 days ]
    Ventilator-free days from last extubation day until day 28 after recruitment
  • Hospital length of stay [ Time Frame: 28 days ]
    Days hospitalized
  • Time to a 2-fold decrease in ferritin [ Time Frame: 14 days ]
    Number of days until a 2-fold decrease in ferritin (ng/mL)
  • 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)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ozone Auto-hemotherapy for COVID-19 Pneumonia
Official Title  ICMJE A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE Biological: Ozone auto-hemotherapy
ozone auto-hemotherapy
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Ozone auto-hemotherapy
  • No Intervention: Standard treatment alone
    Standard treatment will be the one used in each hospital participating in the trial.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 25, 2020
Estimated Primary Completion Date October 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alberto Hernández, MD, PhD +34 637930993 albimar23@yahoo.es
Contact: Marc Vives, MD, PhD +34 690277088 marcvives50@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04370223
Other Study ID Numbers  ICMJE COVID-19 Networking group
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study Sponsor  ICMJE Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators  ICMJE Clinica Nuestra Senora del Rosario
Investigators  ICMJE Not Provided
PRS Account Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP