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| Name | Class |
|---|---|
| Clinica Nuestra Senora del Rosario | OTHER |
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This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia.
Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone.
Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial.
All analyses will be done according to the intention-to-treat principle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone auto-hemotherapy plus standard treatment | Experimental | Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. |
|
| Standard treatment alone | No Intervention | Standard treatment will be the one used in each hospital participating in the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone auto-hemotherapy | Biological | ozone auto-hemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients achieving improvement in clinical condition at day 14 after recruitment | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at day 28 | mortality | 28 days |
| Rate of patients achieving improvement in clinical condition at day 28 after recruitment | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Hernández, MD, PhD | Contact | +34 637930993 | albimar23@yahoo.es | |
| Marc Vives, MD, PhD | Contact | +34 690277088 | marcvives50@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Dr Josep Trueta | Girona | 17007 | Spain | |||
| Clinica Nuestra Señora del Rosario |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 28 days |
| Rate of patients achieving improvement in clinical condition at day 7 after recruitment | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) | 7 days |
| Time to clinical improvement or hospital discharge | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) | 28 days |
| Number of ventilator-free days at 28 days | Ventilator-free days from last extubation day until day 28 after recruitment | 28 days |
| Hospital length of stay | Days hospitalized | 28 days |
| Time to a 2-fold decrease in ferritin | Number of days until a 2-fold decrease in ferritin (ng/mL) | 14 days |
| Time to a 2-fold decrease in C-protein reactive | Number of days until a 2-fold decrease in C-Protein Reactive (mg/L) | 14 days |
| Time to a 2-fold decrease in Dimer-D | Number of days until a 2-fold decrease in Dimer-D (ng/mL) | 14 days |
| Time to a 2-fold decrease in Lactate Dehydrogenase | Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L) | 14 days |
| Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio | Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio | 14 days |
| Ibiza Town |
| Spain |
| Hospital Quirón Rey Juan Carlos I | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
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| Hospital Universitario Infanta Leonor | Madrid | Spain |
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| Hospital Universitario Príncipe de Asturias de Alcalá de Henares | Madrid | Spain |
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| Fundació Althaia de Manresa | Manresa | Spain |
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| Hospital Vithas Valencia Consuelo | Valencia | Spain |
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| Hospital Clínico Universitario de Valladolid | Valladolid | Spain |
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| Clinica Claro | Vigo | Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |