Trials / Terminated
TerminatedNCT06202521
CX-4945 in Viral Community Acquired Pneumonia
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Senhwa Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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 Screening visit will collect health information and perform protocol specified tests to determine patients' eligibility. After screening visit, eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms. The CX-4945 will be administered at 400 mg BID for 5 days. Subjects will be followed up until Day 29.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CX-4945 (SARS-CoV-2 domain) | CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. |
| DRUG | Placebo (SARS-CoV-2 domain) | The dosage and frequency is the same as active drug. |
| DRUG | CX-4945 (Influenza virus domain) | CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. |
| DRUG | Placebo (Influenza virus domain) | The dosage and frequency is the same as active drug. |
Timeline
- Start date
- 2024-03-20
- Primary completion
- 2025-04-22
- Completion
- 2025-04-22
- First posted
- 2024-01-11
- Last updated
- 2026-01-08
- Results posted
- 2026-01-08
Locations
7 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06202521. Inclusion in this directory is not an endorsement.