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

Primary Purpose

COVID-19 Pneumonia

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Ozone auto-hemotherapy
Sponsored by
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Ozone therapy, Covid-19, SARS-COV-2

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari Dr Josep Trueta
  • Clinica Nuestra Señora del Rosario
  • Hospital Quirón Rey Juan Carlos I
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario Príncipe de Asturias de Alcalá de Henares
  • Fundació Althaia de Manresa
  • Hospital Vithas Valencia Consuelo
  • Hospital Clínico Universitario de Valladolid
  • Clinica Claro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ozone auto-hemotherapy plus standard treatment

Standard treatment alone

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mortality at day 28
mortality
Rate of patients achieving improvement in clinical condition at day 28 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)
Rate of patients achieving improvement in clinical condition at day 7 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)
Time to clinical improvement or hospital discharge
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
Ventilator-free days from last extubation day until day 28 after recruitment
Hospital length of stay
Days hospitalized
Time to a 2-fold decrease in ferritin
Number of days until a 2-fold decrease in ferritin (ng/mL)
Time to a 2-fold decrease in C-protein reactive
Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
Time to a 2-fold decrease in Dimer-D
Number of days until a 2-fold decrease in Dimer-D (ng/mL)
Time to a 2-fold decrease in Lactate Dehydrogenase
Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio

Full Information

First Posted
April 27, 2020
Last Updated
June 4, 2020
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators
Clinica Nuestra Senora del Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT04370223
Brief Title
Ozone Auto-hemotherapy for COVID-19 Pneumonia
Acronym
COVID-OZONE
Official Title
A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Anticipated)
Primary Completion Date
October 25, 2020 (Anticipated)
Study Completion Date
December 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators
Clinica Nuestra Senora del Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Ozone therapy, Covid-19, SARS-COV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozone auto-hemotherapy plus standard treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment alone
Arm Type
No Intervention
Arm Description
Standard treatment will be the one used in each hospital participating in the trial.
Intervention Type
Biological
Intervention Name(s)
Ozone auto-hemotherapy
Intervention Description
ozone auto-hemotherapy
Primary Outcome Measure Information:
Title
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
Description
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 Frame
14 days
Secondary Outcome Measure Information:
Title
Mortality at day 28
Description
mortality
Time Frame
28 days
Title
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
Description
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 Frame
28 days
Title
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
Description
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 Frame
7 days
Title
Time to clinical improvement or hospital discharge
Description
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 Frame
28 days
Title
Number of ventilator-free days at 28 days
Description
Ventilator-free days from last extubation day until day 28 after recruitment
Time Frame
28 days
Title
Hospital length of stay
Description
Days hospitalized
Time Frame
28 days
Title
Time to a 2-fold decrease in ferritin
Description
Number of days until a 2-fold decrease in ferritin (ng/mL)
Time Frame
14 days
Title
Time to a 2-fold decrease in C-protein reactive
Description
Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
Time Frame
14 days
Title
Time to a 2-fold decrease in Dimer-D
Description
Number of days until a 2-fold decrease in Dimer-D (ng/mL)
Time Frame
14 days
Title
Time to a 2-fold decrease in Lactate Dehydrogenase
Description
Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
Time Frame
14 days
Title
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Description
Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Hernández, MD, PhD
Phone
+34 637930993
Email
albimar23@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Vives, MD, PhD
Phone
+34 690277088
Email
marcvives50@gmail.com
Facility Information:
Facility Name
Hospital Universitari Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Clinica Nuestra Señora del Rosario
City
Ibiza
Country
Spain
Facility Name
Hospital Quirón Rey Juan Carlos I
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelia Zurera Plaza, MD
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Ripolles, MD, PhD
Facility Name
Hospital Universitario Príncipe de Asturias de Alcalá de Henares
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Angel Garcia, MD
Facility Name
Fundació Althaia de Manresa
City
Manresa
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antònia Flor, MD
Facility Name
Hospital Vithas Valencia Consuelo
City
Valencia
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Baeza, MD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Tamayo, MD, PhD
Facility Name
Clinica Claro
City
Vigo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ozone Auto-hemotherapy for COVID-19 Pneumonia

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