Community-acquired Pneumonia Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of Silmitasertib (CX-4945) in Combination With Standard of Care (SOC) for Treating Patients With Community-Acquired Pneumonia (CAP) Associated With SARS-CoV-2 and Influenza Viral Infections
This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.
Domain I: SARS-CoV-2 domain - Arm 1: CX-4945 (400 mg BID for 5 days) +SOC - Arm 2: Placebo + SOC Domain II: Influenza virus domain - Arm 3: CX-4945 (400 mg BID for 5 days) +SOC - Arm 4: Placebo + SOC After screening visit, eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms. CX-4945 will be administered at 400 mg BID for up to 5 days. After treatment phase, subjects will be followed up for 28 days. ;
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