Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial

• Status: Not yet recruiting
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: All

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-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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