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Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04444531
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief Summary:
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement

Condition or disease
COVID-19 Pneumonia

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
Actual Study Start Date : March 20, 2020
Actual Primary Completion Date : May 19, 2020
Actual Study Completion Date : May 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone Pneumonia

Group/Cohort
Ozone autohemotherapy plus standard treatment
Standard treatment alone



Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 28 days ]
    Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.


Secondary Outcome Measures :
  1. Rate of patients with Clinical improvement at day 14 [ Time Frame: 14 days ]
    Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.

  2. Rate of patients with Clinical improvement at day 28 [ Time Frame: 28 days ]
    Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.

  3. Time to a 2-fold decrease of C-protein reactive from baseline [ Time Frame: 28 days ]
  4. Time to a 2-fold decrease of ferritin from baseline [ Time Frame: 28 days ]
  5. Time to a 2-fold decrease of Lactate Dehydrogenase from baseline [ Time Frame: 28 days ]
  6. Time to a 2-fold decrease of D-dimer from baseline [ Time Frame: 28 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
- Adults >18yo hospitalised patients confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest X-ray abnormalities + oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
Criteria

Inclusion Criteria:

  • confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
  • severe pneumonia with baseline chest X-ray abnormalities;
  • Oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
  • Informed consent signed.

Exclusion Criteria:

  • Not willing to participate in the study.

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): NCT04444531


Locations
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Spain
Policlinic Ibiza Hospital
Ibiza, Spain
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Vives, Clinical Research Lead, MD, PhD, EDAIC, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT04444531    
Other Study ID Numbers: COVID Networking group
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases