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| Name | Class |
|---|---|
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | UNKNOWN |
| Ospedale Civile Santo Spirito, Pescara | UNKNOWN |
| Università Magna Grecia, Catanzaro | UNKNOWN |
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Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tofacitinib+HYQ | Experimental | Tofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days |
|
| Hydroxychloroquine | Active Comparator | Hydroxychloroquine 200mg cp three times a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Jak-1/3 inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of severe Respiratory Failure requiring mechanical ventilation | Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of need of ICU admission | Rate of patients needing admission to the intensive care unit | 28 days |
| Prevention of COVID-19 related Deaths | Rate of patients who die due to COVID-19 related conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armando Gabrielli, MD | Contact | 0712206104 | a.gabrielli@staff.univpm.it |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| A.O. Ospedale Papa Giovanni XXIII |
| OTHER |
| Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma | UNKNOWN |
| ASST Cremona, Cremona | UNKNOWN |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| Ospedale di Circolo e Fondazione Macchi, Varese | UNKNOWN |
Multicenter open label randomized controlled trial
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| Hydroxychloroquine | Drug | Standard Therapy |
|
| 28 days |
| Identification of predictors of outcome | Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D ) | 14 days |
| Incidence of Treatment-Emergent Adverse Events | Rate of severe drug-related adverse events | 28 days |
| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |