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The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone autohemotherapy plus standard treatment | |||
| Standard treatment alone |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement | 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with Clinical improvement at day 14 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinic Ibiza Hospital | Ibiza Town | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33310665 | Derived | Hernandez A, Vinals M, Pablos A, Vilas 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. |
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| 14 days |
| Rate of patients with Clinical improvement at day 28 | 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. | 28 days |
| Time to a 2-fold decrease of C-protein reactive from baseline | 28 days |
| Time to a 2-fold decrease of ferritin 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 |