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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

Tracking Information
First Submitted Date June 22, 2020
First Posted Date June 23, 2020
Last Update Posted Date November 25, 2020
Actual Study Start Date March 20, 2020
Actual Primary Completion Date May 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2020)
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.
Original Primary Outcome Measures
 (submitted: June 22, 2020)
Time to clinical improvement [ Time Frame: 28 days ]
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2020)
  • 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.
  • 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.
  • Time to a 2-fold decrease of C-protein reactive from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of ferritin from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of Lactate Dehydrogenase from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of D-dimer from baseline [ Time Frame: 28 days ]
Original Secondary Outcome Measures
 (submitted: June 22, 2020)
  • Clinical improvement at day 14 [ Time Frame: 14 days ]
  • Clinical improvement at day 28 [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of C-protein reactive from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of ferritin from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of Lactate Dehydrogenase from baseline [ Time Frame: 28 days ]
  • Time to a 2-fold decrease of D-dimer from baseline [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia
Official Title Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
Brief Summary The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition COVID-19 Pneumonia
Intervention Not Provided
Study Groups/Cohorts
  • Ozone autohemotherapy plus standard treatment
  • Standard treatment alone
Publications * Hernández A, Viñals M, Pablos A, Vilás F, Papadakos PJ, Wijeysundera DN, Bergese SD, Vives M. Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study. Int Immunopharmacol. 2021 Jan;90:107261. doi: 10.1016/j.intimp.2020.107261. Epub 2020 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 22, 2020)
18
Original Actual Enrollment Same as current
Actual Study Completion Date May 26, 2020
Actual Primary Completion Date May 19, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04444531
Other Study ID Numbers COVID Networking group
Has Data Monitoring Committee No
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
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Responsible Party Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study Sponsor Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators Not Provided
Investigators Not Provided
PRS Account Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Verification Date November 2020