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The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.
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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
Domain II: Influenza virus domain
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC | Experimental | 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 Comparator | 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: CX-4945 (400 mg BID for 5 days) +SOC | Experimental | 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: Placebo + SOC | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-4945 (SARS-CoV-2 domain) | Drug | CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria
Not currently hospitalized
Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF)
Patients diagnosed with viral pneumonia, as determined by the investigator, who exhibit any of the subsequent criteria: presence of respiratory symptoms or fever (ear temperature ≥ 38 °C, base of the tongue temperature ≥ 37.5 °C, or axillary temperature ≥ 37 °C)
With a pneumonia severity index (PSI) of risk class II or III
Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level
Positive test for SARS-CoV-2 or influenza virus infection, confirmed by rapid diagnostic test (excluding cases where both SARS-CoV-2 and influenza virus are positive)
Confirmed lower respiratory tract infection by X-ray
At screening, subjects capable of childbearing must provide a negative serum or urine pregnancy test. These subjects must also commit to adhering to the study-specified contraceptive methods throughout the study duration
Notes: Acceptable contraceptive methods include:
The participant (or legal representative) agrees and is able to adhere to study protocol-stated requirements, instructions, and restrictions in the investigator's judgement. Furthermore, the participant is capable of understanding and has signed the IRB-approved Informed Consent Form (ICF)
With at least two of the risk factors listed below: Age ≥ 50 years-old; cancer and a life expectancy of ≥ 6 months; HIV infection; immunocompromised patient; congestive heart failure (CHF), or coronary artery disease (CAD), or cardiomyopathies; chronic kidney disease (CKD); chronic liver disease; chronic lung disease; diabetes mellitus (DM); body mass index (BMI) > 25 kg/m2; asthma; cerebrovascular disease; cystic fibrosis; dementia; or current and former smoker
Exclusion Criteria
Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug
Subject has a history of severe renal disease (required phosphate binders or dialysis)
Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks
High likelihood of mortality within the next 48 hours, as assessed by the investigator
Subject showing signs of respiratory failure and mechanical ventilation is required
Subject with liver cirrhosis
Subject with hepatitis B and/or hepatitis C disease, unless the subject has an aspartate aminotransferase (AST) level ranging from 8 to 31 U/L and an alanine aminotransferase (ALT) level from 0 to 41 U/L
Known active tuberculosis
Current documented bacterial infection
Subject has a documented anaphylactic reaction, regardless of cause
Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening
Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase
History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945
Women who are pregnant or breastfeeding, or planning pregnancy during the study
Note: Men and women of reproductive potential must commit to effective contraception methods or abstinence during the study. Any resulting pregnancies or suspected pregnancies must be reported to the treating physician immediately.
ALT or AST levels > 5 times upper limit of normal (ULN)
eGFR <30 mL/min/1.73m2 (calculated by the MDRD formula)
Absolute neutrophil count (ANC) <1000/μL
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have received convalescent COVID-19 plasma treatment
Concurrent use of baricitinib
Any physical findings or illness history that may compromise study results or increase patient risk, as determined by the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Jason Huang, M.D. | Senhwa Biosciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan | ||||
| Far Eastern Memorial Hospital |
Of the 45 enrolled participants, 44 met inclusion criteria and were randomized.
Participants were recruited from individuals diagnosed with Community-Acquired Pneumonia (CAP) associated with SARS-CoV-2 and influenza viral infections at seven sites across Taiwan between February 2024 and March 2025. The first participant was enrolled on March 20, 2024, and the last on February 27, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | SARS-CoV-2 Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2024 | Oct 30, 2025 |
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|
| Placebo (SARS-CoV-2 domain) | Drug | The dosage and frequency is the same as active drug. |
|
| CX-4945 (Influenza virus domain) | Drug | CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. |
|
|
| Placebo (Influenza virus domain) | Drug | The dosage and frequency is the same as active drug. |
|
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. |
| 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. | Day 1 to Day 5/7 |
| 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. | 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. | 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. | Day 1 to Day 5/7, 15, and 29 |
| 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 |
| FG001 |
| SARS-CoV-2 Domain: Placebo + SOC |
Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| FG002 | Influenza Virus Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| FG003 | Influenza Virus Domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ITT population is defined as all randomized subjects who received at least one dose of Silmitasertib (CX-4945) or placebo. This population was used as the primary analysis population for efficacy endpoints and the analysis population for baseline data, safety and exploratory endpoints.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SARS-CoV-2 Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| BG001 | SARS-CoV-2 Domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| BG002 | Influenza Virus Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| BG003 | Influenza Virus Domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 1 to Day 29 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | Day 1 to Day 29 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis. | Posted | Count of Participants | Participants | Baseline to Day 5/7 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The participants were observed to have fever at baseline. | Posted | Median | 95% Confidence Interval | days | Day 1 to Day 5/7 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis. | Posted | Mean | Standard Deviation | ratio change | Day 1 to Day 5/7, 15, and 29 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis. Calculate the percentage of subjects whose health condition has progressed. | Posted | Count of Participants | Participants | Day 1 to Day 5/7, 15, and 29 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis. Calculate the percentage of subjects whose health condition has improved. | Posted | Count of Participants | Participants | Day 1 to Day 5/7, 15, and 29 |
|
From randomization until end of follow-up, up to 32 days
Adverse Events experienced by patients from randomization to Day 29 (± 3 days) (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SARS-CoV-2 Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG001 | SARS-CoV-2 Domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG002 | Influenza Virus Domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. | 0 | 7 | 1 | 7 | 5 | 7 |
| EG003 | Influenza Virus Domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. | 0 | 7 | 0 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment | The subject experienced an SAE of Grade 3 unspecified bacterial pneumonia (unlikely related to the IP) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Suspected drug-induced liver injury | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
|
This trial was terminated early on March 31, 2025 due to insufficient differentiation of the primary endpoint in addressing the unmet medical need, as well as recruitment difficulties caused by the end of the flu season.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Becky Lin, Project Manager of Clinical Department | Senhwa Biosciences | +886-2-8911-9856 | beckylin@senhwabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2025 | Oct 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D009976 | Orthomyxoviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C555142 | silmitasertib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
|
|
| OG002 |
| Influenza virus domain: CX-4945 + SOC |
Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
|
|
| OG002 | Influenza virus domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
|
|
Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
|
|
| OG002 | Influenza virus domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
|
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| OG002 | Influenza virus domain: CX-4945 + SOC | Participants received Silmitasertib (CX-4945) 400 mg capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
| OG003 | Influenza virus domain: Placebo + SOC | Participants received Placebo capsules orally twice a day for 5 days. Participants received Standard of Care (SOC) as assigned by the investigator. 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. |
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| No change |
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| Improved |
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| Normal |
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| Worsen |
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| Improved |
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| Normal |
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| Improved |
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| Normal |
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