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| Name | Class |
|---|---|
| Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy | OTHER_GOV |
| Azienda Ospedaliera Universitaria Senese | OTHER |
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
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It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.
Primary objective
- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with ruxolutinib | SARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Oral Tablet | Drug | Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 | Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of respiratory performance - Arterial Blood Gas Analisys - pH | ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations. | 15 days |
| Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label ruxolitinib treatment in the period between 03/24/2020 and 07/04/2020, with a dosage of at least 20 mg x 2 / day in the first 48 hours
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Dr Capochiani, hematologist | Contact | 00393473527340 | enrico.capochiani@uslnordovest.toscana.it | |
| Barbara Dr Meini, Pharmacist | Contact | 00390586223031 | barbara.meini@uslnordovest.toscana.it |
| Name | Affiliation | Role |
|---|---|---|
| Enrico Dr Capochiani, hematologist | Azienda USL Toscana Nord Ovest | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32850921 | Derived | Capochiani E, Frediani B, Iervasi G, Paolicchi A, Sani S, Roncucci P, Cuccaro A, Franchi F, Simonetti F, Carrara D, Bertaggia I, Nasso D, Riccioni R, Scolletta S, Valente S, Conticini E, Gozzetti A, Bocchia M. Ruxolitinib Rapidly Reduces Acute Respiratory Distress Syndrome in COVID-19 Disease. Analysis of Data Collection From RESPIRE Protocol. Front Med (Lausanne). 2020 Aug 4;7:466. doi: 10.3389/fmed.2020.00466. eCollection 2020. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations. |
| 15 days |
| Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2 | ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations. | 15 days |
| Improvement of respiratory performance - ratio values | PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations. | 15 days |
| Evaluation of known adverse events related to the use of the drug - D-Dimer | every 24 hours D-Dimer value in mgr/ml | 15 days |
| Evaluation of known adverse events related to the use of the drug - fibrinogen | every 24 hours fibrinogen value in mg/dl | 15 days |
| Evaluation of known adverse events related to the use of the drug - transaminases | every 24 hours transaminases value in U/L | 15 days |
| Evaluation of known adverse events related to the use of the drug - aPTT | every 24 hours aPTT value in seconds | 15 days |
| Evaluation of known adverse events related to the use of the drug - INR | every 24 hours INR value in % | 15 days |
| Evaluation of known adverse events related to the use of the drug - glycemia | every 24 hours glycemia value in mg/dl | 15 days |
| Evaluation of known adverse events related to the use of the drug - creatinine | every 24 hours creatinine serum value in mg/dl | 15 days |
| Evaluation of known adverse events related to the use of the drug - Leucocytes count | Total leucocyte as CBC x10e)/L | 15 days |
| Evaluation of known adverse events related to the use of the drug - Leucocytes formula | formula % on total leucocyte | 15 days |
| Evaluation of the epidemiological parameters: Chest CT | Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization. | 15 days |
| Evaluation of the epidemiological parameters: Eco Chest | Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization. | 15 days |
| Evaluation of the epidemiological parameters: CHEST X-ray | Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization. | 15 days |
| Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment | Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h | 15 days |
| Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy | Number of AE grade 1 to 4 | 15 days |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |