Baricitinib Compared to Standard Therapy in Patients With COVID-19
Status:
Not yet recruiting
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
There is urgent need of an effective therapy for Covid-19. To date, the best treatment of
SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for
2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized
antiviral activity.
This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety
of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive
or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing
standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH)
eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all
included patients.
The primary endpoint measure is the efficacy of baricitinib in reducing the number of
patients requiring invasive ventilation after 7 and 14 days of treatment.
Secondary endpoints will be mortality rates and toxicity of baricitinib.