A Phase 2 interventional study of CX-4945 (SARS-CoV-2 domain) and Placebo (SARS-CoV-2 domain) in Community-acquired Pneumonia, SARS-CoV-2 -Associated Pneumonia and Influenza With Pneumonia, sponsored by Senhwa Biosciences, Inc.. Terminated at 7 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Senhwa Biosciences, Inc. · Phase 2, Interventional, and Treatment
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.
82 studies on the registry are indexed under Community-Acquired Pneumonia; 51 are open to participants now.
This study's enrollment of 45 is below the median of 326 across 53 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Senhwa Biosciences, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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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:
Exclusion Criteria
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.
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.
Drug: 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.
Drug: Placebo (SARS-CoV-2 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.
Drug: 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.
Drug: Placebo (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.
Also known as: Silmitasertib
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.
Also known as: Silmitasertib
The dosage and frequency is the same as active drug.
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
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
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.
| Milestone | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC |
|---|---|---|---|---|
| Started | 15 | 15 | 7 | 7 |
| Completed | 15 | 14 | 6 | 6 |
| Not completed | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
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
| Participants | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| 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. | 0 | 0 | 0 | 0 |
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
| Participants | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period. | 0 | 1 | 1 | 0 |
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.
| Participants | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| Day 5/7 — Worsen | 1 | 1 | 1 | 0 |
| Day 5/7 — No change | 1 | 1 | 3 | 0 |
| Day 5/7 — Improved | 8 | 7 | 1 | 5 |
| Day 5/7 — Normal | 5 | 6 | 2 | 1 |
| Day 15 — Worsen | 0 | 0 | 0 | 0 |
| Day 15 — No change | 1 | 0 | 0 | 0 |
| Day 15 — Improved | 5 | 5 | 3 | 2 |
| Day 15 — Normal | 9 | 9 | 3 | 4 |
| Day 29 — Worsen | 0 | 0 | 0 | 0 |
| Day 29 — No change | 0 | 0 | 0 | 0 |
| Day 29 — Improved | 1 | 0 | 2 | 0 |
| Day 29 — Normal | 14 | 14 | 4 | 6 |
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.
| days | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| 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) | 1.8 (NA to NA) | 1.2 (NA to NA) | 1.8 (1.20 to NA) | 1.7 (1.50 to NA) |
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.
| ratio change | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| Day 5/7 | 0.95 ± 3.689 | 0.63 ± 4.359 | 2.04 ± 4.647 | 0.68 ± 5.091 |
| Day 15 | 0.95 ± 2.670 | 1.36 ± 4.736 | 3.17 ± 6.506 | 1.59 ± 3.888 |
| Day 29 | 1.59 ± 3.446 | 1.70 ± 6.083 | 4.76 ± 3.012 | 2.38 ± 5.832 |
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.
| Participants | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| Day 5/7 | 0 | 0 | 0 | 0 |
| Day 15 | 0 | 0 | 1 | 0 |
| Day 29 | 0 | 0 | 0 | 0 |
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.
| Participants | SARS-CoV-2 domain: CX-4945 + SOC | SARS-CoV-2 domain: Placebo + SOC | Influenza virus domain: CX-4945 + SOC | Influenza virus domain: Placebo + SOC |
|---|---|---|---|---|
| Day 5/7 | 2 | 1 | 2 | 1 |
| Day 15 | 4 | 2 | 2 | 1 |
| Day 29 | 5 | 2 | 2 | 1 |
Collected over From randomization until end of follow-up, up to 32 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SARS-CoV-2 Domain: CX-4945 + SOC | 0/15 (0%) | 0/15 (0%) | 10/15 (66.7%) |
| SARS-CoV-2 Domain: Placebo + SOC | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| Influenza Virus Domain: CX-4945 + SOC | 0/7 (0%) | 1/7 (14.3%) | 5/7 (71.4%) |
| Influenza Virus Domain: Placebo + SOC | 0/7 (0%) | 0/7 (0%) | 5/7 (71.4%) |
| Event | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC |
|---|---|---|---|---|
| Pneumonia bacterialInfections and infestations | 0/15 | 0/15 | 1/7 | 0/7 |
| Event | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/15 | 1/15 | 4/7 | 3/7 |
| NauseaGastrointestinal disorders | 4/15 | 1/15 | 1/7 | 0/7 |
| ConstipationGastrointestinal disorders | 0/15 | 0/15 | 1/7 | 1/7 |
| Mouth ulcerationGastrointestinal disorders | 0/15 | 0/15 | 0/7 | 1/7 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 1/15 | 0/15 | 1/7 | 0/7 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 1/7 | 0/7 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 1/7 | 0/7 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 1/7 | 0/7 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 1/7 | 0/7 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 1/7 | 0/7 |
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.
| Age, Continuous(years) | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC | Total |
|---|---|---|---|---|---|
| Mean | 46.3 ± 11.88 | 47.4 ± 11.04 | 48.6 ± 13.35 | 49.0 ± 14.33 | 47.5 ± 11.84 |
| Sex: Female, Male(Participants) | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC | Total |
|---|---|---|---|---|---|
| Female | 9 | 8 | 2 | 4 | 23 |
| Male | 6 | 7 | 5 | 3 | 21 |
| Race (NIH/OMB)(Participants) | SARS-CoV-2 Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | Influenza Virus Domain: Placebo + SOC | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 15 | 15 | 7 | 7 | 44 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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Senhwa Biosciences, Inc.