Community-acquired PneumoniaPhase 2NCT06202521
CX-4945 in Viral Community Acquired Pneumonia
A Phase 2 study testing CX-4945 (SARS-CoV-2 domain) and CX-4945 (Influenza virus domain) in people with Community-acquired Pneumonia and SARS-CoV-2 -Associated Pneumonia, run by Senhwa Biosciences, Inc. at 7 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, SARS-CoV-2 -Associated Pneumonia, Influenza With Pneumonia
- What is being tested?
- CX-4945 (SARS-CoV-2 domain) and CX-4945 (Influenza virus domain)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 7 sitesTaiwan
- Study dates
- 20 Mar 2024to 22 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Kaohsiung Veterans General Hospital
Kaohsiung City
Far Eastern Memorial Hospital
New Taipei City
Taichung Veterans General Hospital
Taichung
National Taiwan University Cancer Center, National Taiwan University Hospital
Taipei
National Taiwan University Hospital
Taipei
Tri-Service General Hospital
Taipei
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan
About this study
Official title: 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
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.
Read the 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.
- Being tested
- CX-4945 (SARS-CoV-2 domain), Placebo (SARS-CoV-2 domain), CX-4945 (Influenza virus domain), Placebo (Influenza virus domain)
- Keywords
- Covid-19, Influenza, Community-acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia, COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-4945 (SARS-CoV-2 domain)Drug
Also called Silmitasertib
CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
Placebo (SARS-CoV-2 domain)Drug
The dosage and frequency is the same as active drug.
CX-4945 (Influenza virus domain)Drug
Also called Silmitasertib
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CX-4945 (SARS-CoV-2 domain) |
| 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. Receives: Drug: Placebo (SARS-CoV-2 domain) |
| 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. Receives: Drug: CX-4945 (Influenza virus domain) |
| 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. Receives: Drug: Placebo (Influenza virus domain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 29
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 5/7, 15, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Mar 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Why it stopped: The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senhwa Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Huang, M.D., Study chair, Senhwa Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202521
- Sponsor's protocol ID
- CX-4945-011
- Status last verified
- Dec 2025
- First submitted
- 1 Jan 2024
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06202521
- Acronym / sponsor ID
- CX-4945-011
- Keywords
- Covid-19, Influenza, Community-acquired Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Senhwa Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC | Experimental | 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. |
| SARS-CoV-2 domain: Placebo + SOC | Placebo comparator | Drug: 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: CX-4945 (400 mg BID for 5 days) +SOC | Experimental | 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. |
| Influenza virus domain: Placebo + SOC | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-4945 (SARS-CoV-2 domain)Also: SilmitasertibCX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. | Drug | SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC |
| Placebo (SARS-CoV-2 domain)The dosage and frequency is the same as active drug. | Drug | SARS-CoV-2 domain: Placebo + SOC |
| CX-4945 (Influenza virus domain)Also: SilmitasertibCX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC. | Drug | Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC |
| Placebo (Influenza virus domain)The dosage and frequency is the same as active drug. | Drug | Influenza virus domain: Placebo + SOC |
Primary outcome
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.
Time frame: 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
6 secondary outcomes
The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.
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
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 frame: Day 1 to Day 5/7
Change From Baseline in SpO2/FiO2 Ratio
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
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
Time frame: Day 1 to Day 5/7, 15, and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Huang, M.D. study chair
Senhwa Biosciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX-4945 (SARS-CoV-2 domain) and CX-4945 (Influenza virus domain) in people with Community-acquired Pneumonia and SARS-CoV-2 -Associated Pneumonia, run by Senhwa Biosciences, Inc. at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1 to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.