Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Time to clinical improvement
Study Overview
Brief Summary
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Time to a 2-fold decrease of ferritin from baseline(28 days)
- Rate of patients with Clinical improvement at day 14(14 days)
- Time to a 2-fold decrease of D-dimer from baseline(28 days)
- Rate of patients with Clinical improvement at day 28(28 days)
- 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)
Investigators
Marc Vives
Clinical Research Lead, MD, PhD, EDAIC
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta