Trial Outcomes & Findings for Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19 (NCT NCT04663737)

NCT ID: NCT04663737

Last Updated: 2025-01-16

Results Overview

To assess adverse events associated with the administration of CX-4945 orally, twice daily to patients with moderate COVID-19. The occurrence of overall AEs in the two treatment groups are summarized.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: From randomization (Day 1) to Day 60
• Results posted on: 2025-01-16

Participant Flow

30 Nov 2020 - First Patient First Visit; 04 Oct 2021 - Last Patient Last Visit.

Participant milestones

Measure	Group A Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Overall Study STARTED	10	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Group A Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19

Baseline characteristics by cohort

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.	Total n=20 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 14.18 • n=5 Participants	50.7 years STANDARD_DEVIATION 14.86 • n=7 Participants	47.3 years STANDARD_DEVIATION 14.56 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Study Site 001-CARE (Center for Advanced Research & Education)	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Study Site 002-CAR (CA's Research)	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization (Day 1) to Day 60

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

To assess adverse events associated with the administration of CX-4945 orally, twice daily to patients with moderate COVID-19. The occurrence of overall AEs in the two treatment groups are summarized.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group	9 Participants	4 Participants

SECONDARY outcome

Timeframe: First 14 days of the study.

Population: 2 patients in Group A, 3 patients in Group B were censored from this analysis per protocol.

To compare the number of days to clinical recovery specifically associated with COVID-19 in the CX-4945 treatment group as compared to the control arm by Day 14 of the study.

Outcome measures

Measure	Group A n=8 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=7 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group	7 Days Interval 4.0 to 12.0	14 Days Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Quantitative changes in viral load from Day 1 to Day 28.

To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Anti-Viral Activity of CX-4945 Viral Clearance Day 8 · Negative	4 Participants	6 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 8 · Positive	3 Participants	2 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 8 · Inconclusive	2 Participants	0 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 8 · Not Evaluated	1 Participants	2 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 14 (EOT) · Negative	5 Participants	7 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 14 (EOT) · Positive	0 Participants	1 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 14 (EOT) · Inconclusive	2 Participants	1 Participants
Anti-Viral Activity of CX-4945 Viral Clearance Day 14 (EOT) · Not Evaluated	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

Population: Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A.

To evaluate the maximum plasma concentration of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A).

Outcome measures

Measure	Group A n=4 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Maximum Plasma Concentration [Cmax] of CX-4945 Day 1	19035.99 ng/mL Standard Deviation 15918.33	—
Maximum Plasma Concentration [Cmax] of CX-4945 Day 14	38749.51 ng/mL Standard Deviation 32469.52	—

SECONDARY outcome

Timeframe: Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

Population: Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A.

To evaluate the time to maximum observed plasma concentration of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A).

Outcome measures

Measure	Group A n=4 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945 Day 1	1.75 h Standard Deviation 0.96	—
Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945 Day 14	1.83 h Standard Deviation 1.23	—

SECONDARY outcome

Timeframe: Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

Population: Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A.

To evaluate the area under the concentration-time curve [AUC0-6] of CX-4945 when given at 1000 mg BID PO (Experimental Arm taking CX-4945 only i.e. Group A).

Outcome measures

Measure	Group A n=4 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Area Under the Concentration-Time Curve [AUC0-6] of CX-4945 Day 1	28168.66 h*ng/mL Standard Deviation 16768.15	—
Area Under the Concentration-Time Curve [AUC0-6] of CX-4945 Day 14	66147.81 h*ng/mL Standard Deviation 34540.93	—

SECONDARY outcome

Timeframe: From Randomization (Day 1) through Day 60

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Between the experimental arm with CX-4945 and the control arm, moderate COVID-19 patients' health status will be evaluated in terms of all-cause mortality. Mortality status and cause will be assessed by study staff and the information will be documented on a Clinical Status questionnaire. The data collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in all-cause mortality between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. All-cause Mortality Status - the Number of Deaths Occurred in Each Treatment Group From Randomization (Day 1) Through Day 60	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Randomization (Day 1) through Day 45

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Between the experimental arm with CX-4945 and the control arm, moderate COVID-19 patients' health status will be evaluated in terms of the number of respiratory failures. Respiratory failures will be assessed by study staff and the information will be documented on a Clinical Status questionnaire. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in number of respiratory failures between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Number of Respiratory Failures Occurred in Each Treatment Group From Randomization (Day 1) Through Day 45	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Randomization (Day 1) to Day 45

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Between the experimental arm with CX-4945 and the control arm, patients will be evaluated in terms of the number of subjects hospitalized in each treatment group. The number of subjects hospitalized will be assessed and the information will be documented on a clinical status questionnaire. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in number of subjects hospitalized between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Number of Subjects Hospitalized in Each Treatment Group From Randomization (Day 1) to Day 45	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Between the experimental arm with CX-4945 and the control arm, patients will be evaluated in terms of time to oxygen saturation level normalization. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in time to oxygen saturation level normalization between those whose treatment included CX-4945 and those whose treatment did not include CX-4945. Best Case Scenario = Days to first response for responder, = Days to last observation for non-responder (censored); Worst Case Scenario = Days to first response for responder, = Days to planned last observation date (31 for EQ-5D-5L and SARS-COV-2 Viral Clearance at visit 7, 45 for others at visit 8) for non-responder (censored); Days to first response = date of first response - the first treatment date/time + 1 Days to last observation = date of last evaluation - the first treatment date/time + 1 For Arm SOC, the first treatment date is the date of visit 2.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Number of Days to Normalization of Oxygen Saturation Level Measured by Pulse Oximeter at Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 and Categorized as <96% Versus ≥96%. Worst Case Scenario	2 days Standard Error 0.7	4 days Standard Error 1.4
Clinical Benefit of CX-4945 i.e. Number of Days to Normalization of Oxygen Saturation Level Measured by Pulse Oximeter at Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 and Categorized as <96% Versus ≥96%. Best Case Scenario	2 days Standard Error 0.7	4 days Standard Error 1.4

SECONDARY outcome

Timeframe: From Randomization (Day 1) to Day 28

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Between the experimental arm with CX-4945 and the control arm, proportion of subjects with disease progression or improvement in health status occurring from Randomization (Day 1) to Day 28 will be evaluated. Disease progression is defined as change in subject health status assessment from item 7 to items 1- 6 and health improvement -as change from item 7 to item 8, evaluated by the ordinal NIAID 8- point Clinical Progression Outcomes scale - collected at every visit from randomization (Day 1) through Day 45. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in clinical status between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 8 (Day 45), LOCF · Else	2 Participants	4 Participants
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 7 (Day 28) · Improvement	6 Participants	7 Participants
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 7 (Day 28) · Progression	0 Participants	0 Participants
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 7 (Day 28) · Else	2 Participants	3 Participants
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 8 (Day 45), LOCF · Improvement	6 Participants	6 Participants
Clinical Benefit of CX-4945 i.e. Proportion of Subjects With Disease Progression or Improvement in Health Status Occurring From Randomization (Day 1) to Day 28. Baseline to Visit 8 (Day 45), LOCF · Progression	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 8, Day 14 and Day 28.

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Changes in the total score for Q1~Q5 of the EQ-D5-5L (used as an indicator of symptom improvement) from Baseline (Day 1) to Day 8, 14, 28 were evaluated. The 5-level EQ-5D version (EQ-5D-5L) was used to assess five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Four times during the study (baseline, Day 8, Day 14 and Day 28) the patients were asked to complete health status survey by answering 6 questions about their health and quality of life. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients were also asked to assess their overall health status by selecting a number between 1 and 100 to describe the condition of their health, 100 being the best imaginable.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Changes in the Total Score for Q1~Q5 of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 4 (Day 8) - Visit 2 (Day 1)	-2.2 score on a scale Standard Deviation 2.39	-1.3 score on a scale Standard Deviation 2.67
Clinical Benefit of CX-4945 i.e. Changes in the Total Score for Q1~Q5 of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 6 (Day 14, EOT) - Visit 2 (Day 1)	-3.0 score on a scale Standard Deviation 2.31	-3.3 score on a scale Standard Deviation 2.00
Clinical Benefit of CX-4945 i.e. Changes in the Total Score for Q1~Q5 of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 7 (Day 28, F1), LOCF - Visit 2 (Day 1)	-3.5 score on a scale Standard Deviation 0.93	-3.9 score on a scale Standard Deviation 2.88

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 8, Day 14 and Day 28.

Population: Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects.

Changes in the Imaginable Health Status of the EQ-D5-5L (used as an indicator of symptom improvement) from Baseline (Day 1) to Day 8, 14, 28 were evaluated. The 5-level EQ-5D version (EQ-5D-5L) was used to assess five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Four times during the study (baseline, Day 8, Day 14 and Day 28) the patients were asked to complete health status survey by answering 6 questions about their health and quality of life. Patients were also asked to assess their overall health status by selecting a number between 1 and 100 to describe the condition of their health, 100 being the best imaginable.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Clinical Benefit of CX-4945 i.e. Changes in the Imaginable Health Status of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 4 (Day 8) - Visit 2 (Day 1)	15.7 score on a scale Standard Deviation 11.80	16.5 score on a scale Standard Deviation 7.09
Clinical Benefit of CX-4945 i.e. Changes in the Imaginable Health Status of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 6 (Day 14, EOT) - Visit 2 (Day 1)	24.1 score on a scale Standard Deviation 12.40	30.3 score on a scale Standard Deviation 11.87
Clinical Benefit of CX-4945 i.e. Changes in the Imaginable Health Status of the EQ-D5-5L From Randomization (Day 1) to Day 8, Day 14 and Day 28. Visit 7 (Day 28, F1), LOCF - Visit 2 (Day 1)	28.8 score on a scale Standard Deviation 19.83	39.5 score on a scale Standard Deviation 9.85

SECONDARY outcome

Timeframe: Changes in plasma IL-6 level from Randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma IL-6 (interleukin-6 in ng/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma IL-6 levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma IL-6 Adjusted Visit 3 (Day 4) - Baseline	1.43 ng/L Standard Deviation 1.511	-2.73 ng/L Standard Deviation 6.784
CX-4945 Inflammatory Marker Outcomes i.e. Plasma IL-6 Adjusted Visit 4 (Day 8) - Baseline	25.08 ng/L Standard Deviation 39.828	2.83 ng/L Standard Deviation 5.550
CX-4945 Inflammatory Marker Outcomes i.e. Plasma IL-6 Adjusted Visit 5 (Day 11) - Baseline	-14.35 ng/L Standard Deviation 27.882	0.40 ng/L Standard Deviation 4.363
CX-4945 Inflammatory Marker Outcomes i.e. Plasma IL-6 Adjusted Visit 6 (Day 14) - Baseline	-23.47 ng/L Standard Deviation 34.018	-10.06 ng/L Standard Deviation NA In the CSR, 'M' is noted in the SD column likely indicates extensive missing data, with 1 analyzed and 9 missing.

SECONDARY outcome

Timeframe: Changes in CRP from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma CRP (C-reactive protein in mg/DL) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma CRP levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CRP Adjusted Visit 3 (Day 4) - Baseline	0.17 mg/dL Standard Deviation 0.261	-0.40 mg/dL Standard Deviation 1.752
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CRP Adjusted Visit 4 (Day 8) - Baseline	-0.14 mg/dL Standard Deviation 0.622	-0.61 mg/dL Standard Deviation 1.508
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CRP Adjusted Visit 5 (Day 11) - Baseline	-0.77 mg/dL Standard Deviation 1.513	-0.59 mg/dL Standard Deviation 1.379
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CRP Adjusted Visit 6 (Day 14) - Baseline	-0.72 mg/dL Standard Deviation 1.597	-0.51 mg/dL Standard Deviation 1.520

SECONDARY outcome

Timeframe: Changes in LDH from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma LDH (lactic acid dehydrogenase in U/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma LDH levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma LDH Adjusted Visit 3 (Day 4) - Baseline	7.11 U/L Standard Deviation 23.661	48.71 U/L Standard Deviation 97.324
CX-4945 Inflammatory Marker Outcomes i.e. Plasma LDH Adjusted Visit 4 (Day 8) - Baseline	28.78 U/L Standard Deviation 122.942	47.57 U/L Standard Deviation 100.565
CX-4945 Inflammatory Marker Outcomes i.e. Plasma LDH Adjusted Visit 5 (Day 11) - Baseline	-29.17 U/L Standard Deviation 79.200	12.86 U/L Standard Deviation 34.868
CX-4945 Inflammatory Marker Outcomes i.e. Plasma LDH Adjusted Visit 6 (Day 14) - Baseline	-6.67 U/L Standard Deviation 98.659	50.00 U/L Standard Deviation 87.088

SECONDARY outcome

Timeframe: Changes in CPK from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma CPK (creatine phosphokinase in U/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma CPK levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CPK Adjusted Visit 3 (Day 4) - Baseline	6.11 U/L Standard Deviation 64.297	-14.50 U/L Standard Deviation 36.154
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CPK Adjusted Visit 4 (Day 8) - Baseline	11.89 U/L Standard Deviation 116.393	-12.13 U/L Standard Deviation 24.908
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CPK Adjusted Visit 5 (Day 11) - Baseline	-30.14 U/L Standard Deviation 72.073	-17.25 U/L Standard Deviation 25.811
CX-4945 Inflammatory Marker Outcomes i.e. Plasma CPK Adjusted Visit 6 (Day 14) - Baseline	-23.56 U/L Standard Deviation 64.211	-16.86 U/L Standard Deviation 31.882

SECONDARY outcome

Timeframe: Changes in ferritin from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma ferritin (μg/L) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma ferritin levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma Ferritin Adjusted Visit 4 (Day 8) - Baseline	-57.52 μg/L Standard Deviation 175.573	-37.99 μg/L Standard Deviation 73.496
CX-4945 Inflammatory Marker Outcomes i.e. Plasma Ferritin Adjusted Visit 3 (Day 4) - Baseline	-18.35 μg/L Standard Deviation 44.322	2.02 μg/L Standard Deviation 5.454
CX-4945 Inflammatory Marker Outcomes i.e. Plasma Ferritin Adjusted Visit 5 (Day 11) - Baseline	-90.07 μg/L Standard Deviation 251.589	-63.03 μg/L Standard Deviation 76.342
CX-4945 Inflammatory Marker Outcomes i.e. Plasma Ferritin Adjusted Visit 6 (Day 14) - Baseline	-152.12 μg/L Standard Deviation 421.528	-79.10 μg/L Standard Deviation 96.784

SECONDARY outcome

Timeframe: Changes in D-dimer from randomization (Day 1) to Day 4, Day 8, Day 11, and Day 14.

Population: Population: Safety Population; The Safety population is defined as any subject receiving at least one dose of CX-4945 or standard of care treatment after randomization.

Labs to evaluate changes in plasma D-dimer (μg/mL) levels between the patients within the experimental arm with CX-4945 and the control arm, of patients with moderate COVID-19. The information collected will be analyzed at the conclusion of the study to determine if there is a statistically significant difference in plasma D-dimer levels between those whose treatment included CX-4945 and those whose treatment did not include CX-4945.

Outcome measures

Measure	Group A n=10 Participants Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib. Silmitasertib: Capsules 1000mg/BID	Group B n=10 Participants Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
CX-4945 Inflammatory Marker Outcomes i.e. Plasma D-Dimer Adjusted Visit 3 (Day 4) - Baseline	0.00 μg/mL Standard Deviation 0.118	-0.21 μg/mL Standard Deviation 0.544
CX-4945 Inflammatory Marker Outcomes i.e. Plasma D-Dimer Adjusted Visit 4 (Day 8) - Baseline	-0.10 μg/mL Standard Deviation 0.164	0.13 μg/mL Standard Deviation 0.152
CX-4945 Inflammatory Marker Outcomes i.e. Plasma D-Dimer Adjusted Visit 5 (Day 11) - Baseline	-0.08 μg/mL Standard Deviation 0.138	-0.01 μg/mL Standard Deviation 0.007
CX-4945 Inflammatory Marker Outcomes i.e. Plasma D-Dimer Adjusted Visit 6 (Day 14) - Baseline	-0.04 μg/mL Standard Deviation NA In the CSR, 'M' is noted in the SD column likely indicates extensive missing data, with 1 analyzed and 9 missing.	-0.09 μg/mL Standard Deviation 0.170

Adverse Events

Group A

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Group B

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A n=10 participants at risk Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib Silmitasertib: Capsules	Group B n=10 participants at risk Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Infections and infestations COVID-19	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Infections and infestations COVID-19 pneumonia	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.

Other adverse events

Measure	Group A n=10 participants at risk Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib Silmitasertib: Capsules	Group B n=10 participants at risk Group B (control) that will receive the same care as the Group A but without Silmitasertib SOC: Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
Cardiac disorders Palpitations	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Eye disorders Photopsia	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Abdominal pain upper	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Diarrhoea	40.0% 4/10 • Number of events 4 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Dyschezia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 2 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
General disorders Chest pain	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	20.0% 2/10 • Number of events 2 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Hepatobiliary disorders Hyperbilirubinaemia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Infections and infestations Bronchitis	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Infections and infestations Hepatitis viral	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Infections and infestations Urinary tract infection	20.0% 2/10 • Number of events 2 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Infections and infestations Viral infection	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Blood creatine phosphokinase increased	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Glucose urine present	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Haemoglobin increased	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Hepatic enzyme increased	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Platelet count increased	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Investigations Urine analysis abnormal	20.0% 2/10 • Number of events 2 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Metabolism and nutrition disorders Hyperalbuminaemia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Metabolism and nutrition disorders Hypercalcaemia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Metabolism and nutrition disorders Hypokalaemia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Metabolism and nutrition disorders Metabolic acidosis	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Nervous system disorders Tremor	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Number of events 1 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.	0.00% 0/10 • From randomization (Day 1) to Day 60 Adverse events occurring from randomization (Day 1) to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity \[(as graded by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download)\], timing, seriousness, and relationship to study therapy.

Additional Information

Kacy Huang, Director of Clinical Department

Senhwa Biosciences, Inc.

Phone: +886-2-8911-9856

Email: kacyhuang@senhwabio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place