Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial
Status:
Not yet recruiting
Trial end date:
2020-11-15
Target enrollment:
Participant gender:
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.