CX-4945 in Viral Community Acquired Pneumonia

Phase 2

Terminated

• Conditions: Community-acquired Pneumonia; SARS-CoV-2 -Associated Pneumonia; Influenza With Pneumonia
• Interventions: Drug: CX-4945 (SARS-CoV-2 domain); Drug: Placebo (SARS-CoV-2 domain); Drug: Placebo (Influenza virus domain); Drug: CX-4945 (Influenza virus domain)

• Registration Number: NCT06202521
• Lead Sponsor: Senhwa Biosciences, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Study Start: 2024-02-27
• Primary Completion: 2025-04-22
• Study Completion: 2025-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC	CX-4945 (SARS-CoV-2 domain)	Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.
SARS-CoV-2 domain: Placebo + SOC	Placebo (SARS-CoV-2 domain)	Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.
Influenza virus domain: Placebo + SOC	Placebo (Influenza virus domain)	Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.
Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC	CX-4945 (Influenza virus domain)	Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

Primary Outcome Measures

Name	Time	Method
The percentage of subjects requiring hospitalization, including emergency room visits, or resulting in death due to progression of CAP related to SARS-CoV-2 or influenza.	Day 1 to Day 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared to placebo plus SOC, in preventing the progression of CAP associated with SARS-CoV-2 and influenza virus infection

Secondary Outcome Measures

Name	Time	Method
The percentage of subjects with all cause hospitalization, emergency room visits, or death during study period.	Day 1 to Day 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
The percentage of subjects with improved pulmonary X-ray findings for pneumonia, relative to baseline or showing a return to normalcy	Baseline to Day 7, 15, and 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
The symptom resolution for fever is defined as body temperature lower than the following definition for 24 hours (ear temperature < 38 °C, base of the tongue temperature < 37.5 °C, or axillary temperature < 37 °C)	Day 1 to Day 7	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
Change from baseline in SpO2/FiO2 ratio	Day 1 to Day 7, 15, and 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
The percentage of subjects exhibiting disease progression in health status Disease progression is defined as an increase of score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale	Day 1 to Day 7, 15, and 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
The percentage of subjects exhibiting health improvement in health status Health improvement is defined as a reduction of score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale	Day 1 to Day 7, 15, and 29	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition (Scale range: 1-8, with higher scores indicating a worse condition)
The percentage of subjects with a negative RT-PCR result for the SARS-CoV-2 (only for SARS-CoV-2 domain) or the influenza virus (only for influenza virus domain) on Day 7.	Day 1 and Day 7	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, on reducing viral presence
Change from baseline in viral load in nasal secretions by RT-PCR (only for SARS-CoV-2 domain)	Day 1 and Day 7	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, on reducing viral presence
Change from baseline in Ct values (only for SARS-CoV-2 domain)	Day 1 and Day 7	To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, on reducing viral presence
TEAEs and SAEs	Day 1 to Day 29	To evaluate the safety and tolerability of Silmitasertib (CX-4945)
Laboratory test	Day 1 to Day 29	To evaluate the safety and tolerability of Silmitasertib (CX-4945)
Vital signs	Day 1 to Day 29	To evaluate the safety and tolerability of Silmitasertib (CX-4945)
Electrocardiogram (ECG) results	Baseline to Day 29	To evaluate the safety and tolerability of Silmitasertib (CX-4945)

Trial Locations

Locations (7)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Cancer Center, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Taoyuan General Hospital, Ministry of Health and Welfare; 🇨🇳 Taoyuan, Taiwan