Community-acquired Pneumonia, Influenza With Pneumonia, SARS-CoV-2 -Associated Pneumonia
Conditions
Keywords
Covid-19, Influenza, Community-acquired Pneumonia
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.
Interventions
DRUGCX-4945 (SARS-CoV-2 domain)
CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
DRUGPlacebo (SARS-CoV-2 domain)
The dosage and frequency is the same as active drug.
DRUGCX-4945 (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.
DRUGPlacebo (Influenza virus domain)
The dosage and frequency is the same as active drug.
Sponsors
Senhwa Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Not currently hospitalized 2. Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF) 3. 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) 4. With a pneumonia severity index (PSI) of risk class II or III 5. Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level 6. 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) 7. Confirmed lower respiratory tract infection by X-ray 8. 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) 9. 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) 10. 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
1. Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug 2. Subject has a history of severe renal disease (required phosphate binders or dialysis) 3. Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks 4. High likelihood of mortality within the next 48 hours, as assessed by the investigator 5. Subject showing signs of respiratory failure and mechanical ventilation is required 6. Subject with liver cirrhosis 7. 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 8. Known active tuberculosis 9. Current documented bacterial infection 10. Subject has a documented anaphylactic reaction, regardless of cause 11. Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening 12. Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis 13. Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase 14. History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945 15. 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. 16. ALT or AST levels \> 5 times upper limit of normal (ULN) 17. eGFR \<30 mL/min/1.73m2 (calculated by the MDRD formula) 18. Absolute neutrophil count (ANC) \<1000/μL 19. Have received treatment with a SARS-CoV-2 specific monoclonal antibody 20. Have received convalescent COVID-19 plasma treatment 21. Concurrent use of baricitinib 22. Any physical findings or illness history that may compromise study results or increase patient risk, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Baseline to Day 5/7 | 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. 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 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 5/7 | 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 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 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 5/7, 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. 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 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 5/7, 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 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. |
| Change From Baseline in SpO2/FiO2 Ratio | Day 1 to Day 5/7, 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 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 45 enrolled participants, 44 met inclusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 7 |
| 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. | 7 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | SARS-CoV-2 Domain: CX-4945 + SOC | Total | Influenza Virus Domain: Placebo + SOC | Influenza Virus Domain: CX-4945 + SOC | SARS-CoV-2 Domain: Placebo + SOC |
|---|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.88 | 47.5 years STANDARD_DEVIATION 11.84 | 49.0 years STANDARD_DEVIATION 14.33 | 48.6 years STANDARD_DEVIATION 13.35 | 47.4 years STANDARD_DEVIATION 11.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 44 Participants | 7 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 23 Participants | 4 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 21 Participants | 3 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 10 / 15 | 4 / 15 | 5 / 7 | 5 / 7 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 1 / 7 | 0 / 7 |
Outcome results
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
Time frame: Day 1 to Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 domain: CX-4945 + 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 Participants |
| SARS-CoV-2 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 Participants |
| Influenza virus domain: CX-4945 + 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 Participants |
| 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 Participants |
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.
Time frame: Day 1 to Day 5/7, 15, and 29
Population: The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SARS-CoV-2 domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 15 | 0.95 ratio change | Standard Deviation 2.67 |
| SARS-CoV-2 domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 29 | 1.59 ratio change | Standard Deviation 3.446 |
| SARS-CoV-2 domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 5/7 | 0.95 ratio change | Standard Deviation 3.689 |
| SARS-CoV-2 domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 15 | 1.36 ratio change | Standard Deviation 4.736 |
| SARS-CoV-2 domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 29 | 1.70 ratio change | Standard Deviation 6.083 |
| SARS-CoV-2 domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 5/7 | 0.63 ratio change | Standard Deviation 4.359 |
| Influenza virus domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 5/7 | 2.04 ratio change | Standard Deviation 4.647 |
| Influenza virus domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 15 | 3.17 ratio change | Standard Deviation 6.506 |
| Influenza virus domain: CX-4945 + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 29 | 4.76 ratio change | Standard Deviation 3.012 |
| Influenza virus domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 15 | 1.59 ratio change | Standard Deviation 3.888 |
| Influenza virus domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 29 | 2.38 ratio change | Standard Deviation 5.832 |
| Influenza virus domain: Placebo + SOC | Change From Baseline in SpO2/FiO2 Ratio | Day 5/7 | 0.68 ratio change | Standard Deviation 5.091 |
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.
Time frame: Day 1 to Day 5/7, 15, and 29
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS-CoV-2 domain: CX-4945 + SOC | 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 5/7 | 0 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | 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 15 | 0 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | 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 29 | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 15 | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 5/7 | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 29 | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 5/7 | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 15 | 1 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 29 | 0 Participants |
| Influenza virus domain: Placebo + SOC | 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 15 | 0 Participants |
| Influenza virus domain: Placebo + SOC | 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 29 | 0 Participants |
| Influenza virus domain: Placebo + SOC | 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 5/7 | 0 Participants |
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.
Time frame: Day 1 to Day 5/7, 15, and 29
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS-CoV-2 domain: CX-4945 + SOC | 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 5/7 | 2 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | 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 29 | 5 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | 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 15 | 4 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 29 | 2 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 15 | 2 Participants |
| SARS-CoV-2 domain: Placebo + SOC | 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 5/7 | 1 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 15 | 2 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 29 | 2 Participants |
| Influenza virus domain: CX-4945 + SOC | 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 5/7 | 2 Participants |
| Influenza virus domain: Placebo + SOC | 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 29 | 1 Participants |
| Influenza virus domain: Placebo + SOC | 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 5/7 | 1 Participants |
| Influenza virus domain: Placebo + SOC | 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 15 | 1 Participants |
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
Time frame: Day 1 to Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period. | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period. | 1 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period. | 1 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period. | 0 Participants |
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.
Time frame: Baseline to Day 5/7
Population: The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | No change | 1 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Worsen | 0 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Improved | 8 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | No change | 0 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Normal | 5 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Worsen | 0 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Improved | 1 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Normal | 14 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Normal | 9 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Improved | 5 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | No change | 1 Participants |
| SARS-CoV-2 domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Worsen | 1 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Normal | 14 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Normal | 9 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Worsen | 1 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | No change | 1 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Improved | 7 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Normal | 6 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Worsen | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | No change | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Improved | 5 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Worsen | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | No change | 0 Participants |
| SARS-CoV-2 domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Improved | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Improved | 3 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Worsen | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Normal | 3 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | No change | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Normal | 4 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | No change | 0 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Improved | 1 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Worsen | 1 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Normal | 2 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | No change | 3 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Improved | 2 Participants |
| Influenza virus domain: CX-4945 + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Worsen | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Normal | 6 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Worsen | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | No change | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Worsen | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Improved | 2 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | No change | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Improved | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 29 | Worsen | 0 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Improved | 5 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 15 | Normal | 4 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | Normal | 1 Participants |
| Influenza virus domain: Placebo + SOC | The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy | Day 5/7 | No change | 0 Participants |
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.
Time frame: Day 1 to Day 5/7
Population: The participants were observed to have fever at baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SARS-CoV-2 domain: CX-4945 + 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 days |
| SARS-CoV-2 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) | 1.2 days |
| Influenza virus domain: CX-4945 + 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 days |
| 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) | 1.7 days |