COVID-19 Pneumonia
Conditions
Brief summary
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
Interventions
None listed
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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 | — |
| Time to a 2-fold decrease of ferritin from baseline | 28 days | — |
Countries
Spain
Outcome results
None listed