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

• ClinicalTrials.gov Identifier: NCT04444531
• Recruitment Status: Completed
• First Posted: June 23, 2020
• Last Update Posted: November 25, 2020
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• 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 ]

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.

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

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