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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
The dosage and frequency is the same as active drug.
CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
Kaohsiung Veterans General Hospital
Kaohsiung City, 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
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.
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
Time frame: Day 1 to Day 29
The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.
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
Time frame: Day 1 to Day 29
The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy
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. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.
Time frame: Baseline to Day 5/7
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)
Time to Symptom Resolution for Fever \[days\]. The symptom resolution for fever is defined as body temperature lower than the following definition (ear temperature \< 38 °C, base of the tongue temperature \< 37.5 °C, or axillary temperature \< 37 °C) Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.
Time frame: Day 1 to Day 5/7
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The dosage and frequency is the same as active drug.
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan District, Taiwan
Change From Baseline in SpO2/FiO2 Ratio
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 Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.
Time frame: Day 1 to Day 5/7, 15, and 29
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
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. NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.
Time frame: Day 1 to Day 5/7, 15, and 29
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
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 NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.
Time frame: Day 1 to Day 5/7, 15, and 29