Status:
UNKNOWN
Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Corona Virus Infection
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-a...
Detailed Description
Baricitinib 4 mg/daily will be prescribed for 7 days to eligible patients showing signs of acute inflammatory response activation. The primary outcome of the study will be the response to treatment. A...
Eligibility Criteria
Inclusion
- Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Baricitinib's efficacy and the labeled warning and precautions as the proposed use is outside the approved indication, as well as the presence of known risk of being treated with Baricitinib while the subject of an active infection
- informed Consent as documented by signature
- patients with a confirmed SARS-CoV-2 pneumonia
- adult patients aged 18-74 years old
- infiltrates at chest radiography
- c-reactive protein level greater than 10 mg/dl or ferritin level \> 900 ug/L
- Lymphocyte count less than 1500/mmc
- \> 200 PaO2/FiO2 ≤ 300
Exclusion
- patients aged \< 18 years old and ≥ 75 years old
- concomitant bacterial infection
- lymphopenia less than 500/mmc
- hemoglobin \< 8 g/dl
- absolute neutrophil count \< 1 x 109 cells/L
- requiring continuous positive airway pressure (C-PAP) or mechanical ventilation
- sudden clinical deterioration requiring intensive care unit access
- known hypersensitivity or allergy to the study drug
- Creatinine clearance \< 30 mL/min; if the creatinine clearance is between 30 and 60 mL/min the dose of Baricitinib should be reduced to 2 mg/daily
- Severe hepatic impairment (no dose adjustment of Baricitinib is required in mild or moderate hepatic impairment)
- Pregnant or breast-feeding
- Active tuberculosis
- Evidence of active hepatitis B (HBV) (HbsAg positive) or with detectable hepatitis C virus (HCV)-RNA, human immunodeficiency virus (HIV)
- Ongoing, acute diagnosis of deep venous thrombosis/pulmonary embolism (DVT/PE)
- Previous diagnosis of DVT/PE
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04399798
Start Date
May 15 2020
End Date
November 15 2020
Last Update
May 22 2020
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