Status:
UNKNOWN
TOFAcitinib in SARS-CoV2 Pneumonia
Lead Sponsor:
Università Politecnica delle Marche
Conditions:
SARS-COv2 Related Interstitial Pneumonia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-...
Detailed Description
Interstitial Pneumonia is the main complication of SARS-CoV2 infection. Immune system hyperactivation, leading to alveolar inflammation, is the main mechanism in determining lung damage. Evidence are ...
Eligibility Criteria
Inclusion
- SARS-CoV2 Infection diagnosed by rt-PCR
- Rx or CT-scan confirmed interstitial pneumonia
- Hospital admission from less than 24h
- Written Informed Consent
Exclusion
- Age \<18 ys or \>65
- Patients in mechanical ventilation at time of admission
- Severe Hearth failure (NYHA 3 or 4)
- Severe History of Chronic Ischemic Hearth Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
- History of recurrent Deep Venous Thrombosis and Pulmonary Embolism
- Active Bacterial or Fungal Infection
- Hematological cancer
- Metastatic or intractable cancer
- Pre-existent neurodegenerative disease
- Severe Hepatic Impairment
- Severe Renal Failure (Creatinine Clearance \<30ml/h)
- Active Herpes zoster infection
- Severe anemia (Hb\<9g/dl)
- Lymphocyte count below 750/mcl
- Neutrophil count below 1000/mcl
- Platelet count below 50000/mcl
- Pregnancy or Lactation
- Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04332042
Start Date
April 10 2020
End Date
July 10 2020
Last Update
April 2 2020
Active Locations (1)
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1
Ospedali Riuniti di Ancona
Ancona, The Marches, Italy, 60126