Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia
- Conditions
- COVID-19 Pneumonia
- Registration Number
- NCT04444531
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 18
- 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.
- Not willing to participate in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical improvement 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
Name Time Method Time to a 2-fold decrease of ferritin from baseline 28 days Rate of patients with Clinical improvement at day 14 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 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 28 days Time to a 2-fold decrease of Lactate Dehydrogenase from baseline 28 days Time to a 2-fold decrease of D-dimer from baseline 28 days
Trial Locations
- Locations (1)
Policlinic Ibiza Hospital
🇪🇸Ibiza, Spain