Corona Virus Infection Clinical Trial
Official title:
A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia
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.
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 patient is considered responder in the absence of either moderate to severe oxygenation impairment or death, whichever occurs first, within 8 days from enrolment. The main secondary outcomes will include the responder rate and mortality at 15 days, the quantification of patients experiencing moderate to severe oxygenation impairment, rate of patients admitted to the intensive care unit, length of hospitalization, mortality at 28 days, rate of re-admission, and adverse events. The duration of the study will be 28 days. In the proof of concept phase, 13 patients will be enrolled; if the responders will be at least 4 patients without safety issues, Baricitinib will be considered for further studies. ;
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