Trial Outcomes & Findings for CX-4945 in Viral Community Acquired Pneumonia (NCT NCT06202521)

NCT ID: NCT06202521

Last Updated: 2026-01-08

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Day 1 to Day 29

Results posted on

2026-01-08

Participant Flow

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.

Of the 45 enrolled participants, 44 met inclusion criteria and were randomized.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	15	15	7	7
Overall Study COMPLETED	15	14	6	6
Overall Study NOT COMPLETED	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Withdrawal by Subject	0	1	0	1
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

CX-4945 in Viral Community Acquired Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SARS-CoV-2 Domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 Domain: Placebo + SOC n=15 Participants 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.	Influenza Virus Domain: CX-4945 + SOC n=7 Participants 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.	Influenza Virus Domain: Placebo + SOC n=7 Participants 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.	Total n=44 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 11.88 • n=18 Participants	47.4 years STANDARD_DEVIATION 11.04 • n=17 Participants	48.6 years STANDARD_DEVIATION 13.35 • n=35 Participants	49.0 years STANDARD_DEVIATION 14.33 • n=42 Participants	47.5 years STANDARD_DEVIATION 11.84 • n=217 Participants
Sex: Female, Male Female	9 Participants n=18 Participants	8 Participants n=17 Participants	2 Participants n=35 Participants	4 Participants n=42 Participants	23 Participants n=217 Participants
Sex: Female, Male Male	6 Participants n=18 Participants	7 Participants n=17 Participants	5 Participants n=35 Participants	3 Participants n=42 Participants	21 Participants n=217 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Asian	15 Participants n=18 Participants	15 Participants n=17 Participants	7 Participants n=35 Participants	7 Participants n=42 Participants	44 Participants n=217 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) White	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 29

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Day 5/7

Population: The participant who has completed Day 5/7, Day 15 or Day 29 is eligible for analysis.

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.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
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	1 Participants	1 Participants	0 Participants
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	1 Participants	3 Participants	0 Participants
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	7 Participants	1 Participants	5 Participants
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	6 Participants	2 Participants	1 Participants
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	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants
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	5 Participants	3 Participants	2 Participants
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	9 Participants	3 Participants	4 Participants
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	14 Participants	4 Participants	6 Participants
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	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants
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	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 5/7

Population: The participants were observed to have fever at baseline.

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.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=1 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=1 Participants 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.	Influenza virus domain: CX-4945 + SOC n=3 Participants 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.	Influenza virus domain: Placebo + SOC n=3 Participants 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.
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 only 1 participant Analyzed	1.2 days only 1 participant Analyzed	1.8 days Interval 1.2 to insufficient number of participants with events	1.7 days Interval 1.5 to insufficient number of participants with events

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
Change From Baseline in SpO2/FiO2 Ratio Day 5/7	0.95 ratio change Standard Deviation 3.689	0.63 ratio change Standard Deviation 4.359	2.04 ratio change Standard Deviation 4.647	0.68 ratio change Standard Deviation 5.091
Change From Baseline in SpO2/FiO2 Ratio Day 15	0.95 ratio change Standard Deviation 2.670	1.36 ratio change Standard Deviation 4.736	3.17 ratio change Standard Deviation 6.506	1.59 ratio change Standard Deviation 3.888
Change From Baseline in SpO2/FiO2 Ratio Day 29	1.59 ratio change Standard Deviation 3.446	1.70 ratio change Standard Deviation 6.083	4.76 ratio change Standard Deviation 3.012	2.38 ratio change Standard Deviation 5.832

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
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	0 Participants	0 Participants	0 Participants
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	0 Participants	1 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SARS-CoV-2 domain: CX-4945 + SOC n=15 Participants 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.	SARS-CoV-2 domain: Placebo + SOC n=15 Participants 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.	Influenza virus domain: CX-4945 + SOC n=7 Participants 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.	Influenza virus domain: Placebo + SOC n=7 Participants 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.
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	1 Participants	2 Participants	1 Participants
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	2 Participants	2 Participants	1 Participants
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	2 Participants	2 Participants	1 Participants

Adverse Events

SARS-CoV-2 Domain: CX-4945 + SOC

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

SARS-CoV-2 Domain: Placebo + SOC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Influenza Virus Domain: CX-4945 + SOC

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Influenza Virus Domain: Placebo + SOC

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SARS-CoV-2 Domain: CX-4945 + SOC n=15 participants at risk 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.	SARS-CoV-2 Domain: Placebo + SOC n=15 participants at risk 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.	Influenza Virus Domain: CX-4945 + SOC n=7 participants at risk 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.	Influenza Virus Domain: Placebo + SOC n=7 participants at risk 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.
Infections and infestations Pneumonia bacterial	0.00% 0/15 • 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.	0.00% 0/15 • 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.	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/7 • 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.

Other adverse events

Additional Information

Becky Lin, Project Manager of Clinical Department

Senhwa Biosciences

Phone: +886-2-8911-9856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60