Trial · NCT04663737
Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19
NCT04663737, Phase 2, Completed, Senhwa Biosciences, Inc.; results first posted 2024-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19. Trials, record NCT04663737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04663737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19
- NCT number
- NCT04663737
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Senhwa Biosciences, Inc.
- Conditions
- Covid19
- Interventions
- Silmitasertib, SOC
- First posted
- 2020-12-11
- Last updated
- 2025-01-16
- Results first posted
- 2024-12-16
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | From randomization (Day 1) to Day 60 | 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. |
| Secondary | Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | First 14 days of the study. | 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. |
| Secondary | Anti-Viral Activity of CX-4945 | 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. |
| Secondary | Maximum Plasma Concentration [Cmax] of CX-4945 | 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. | 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). |
| Secondary | Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945 | 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. | 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). |
| Secondary | Area Under the Concentration-Time Curve [AUC0-6] of CX-4945 | 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. | 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). |
| Secondary | 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 | From Randomization (Day 1) through Day 60 | 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. |
| Secondary | Clinical Benefit of CX-4945 i.e. Number of Respiratory Failures Occurred in Each Treatment Group From Randomization (Day 1) Through Day 45 | From Randomization (Day 1) through Day 45 | 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. |
| Secondary | Clinical Benefit of CX-4945 i.e. Number of Subjects Hospitalized in Each Treatment Group From Randomization (Day 1) to Day 45 | From Randomization (Day 1) to Day 45 | 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. |
| Secondary | 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%. | Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | From randomization (Day 1) to Day 60 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | First 14 days of the study. | 2 patients in Group A, 3 patients in Group B were censored from this analysis per protocol. | Days | MEDIAN |
| SECONDARY | Anti-Viral Activity of CX-4945 | Quantitative changes in viral load from Day 1 to Day 28. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maximum Plasma Concentration [Cmax] of CX-4945 | 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. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945 | 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. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | h | MEAN |
| SECONDARY | Area Under the Concentration-Time Curve [AUC0-6] of CX-4945 | 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. | Plasma sample of CX-4945 are collected from the first four subjects randomized to treatment arm A. | h*ng/mL | MEAN |
| SECONDARY | 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 | From Randomization (Day 1) through Day 60 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Number of Respiratory Failures Occurred in Each Treatment Group From Randomization (Day 1) Through Day 45 | From Randomization (Day 1) through Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit of CX-4945 i.e. Number of Subjects Hospitalized in Each Treatment Group From Randomization (Day 1) to Day 45 | From Randomization (Day 1) to Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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%. | Randomization (Day 1), Day 4, Day 8, Day 11, Day 14, Day 28 and Day 45 | Population: Intent-to-Treat (ITT) Population; The Intent-to-Treat (ITT) population is defined as all randomized subjects. | days | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | Group A | 9 | Participants | ||
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | Group B | 4 | Participants | ||
| Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | Group A | 7 | 95% Confidence Interval 4 to 12 | Days | |
| Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group | Group B | 14 | 95% Confidence Interval 7 to 14 | Days | |
| Anti-Viral Activity of CX-4945 | Group A | Viral Clearance Day 8 / Negative | 4 | Participants | |
| Anti-Viral Activity of CX-4945 | Group B | Viral Clearance Day 8 / Negative | 6 | Participants | |
| Anti-Viral Activity of CX-4945 | Group A | Viral Clearance Day 8 / Positive | 3 | Participants | |
| Anti-Viral Activity of CX-4945 | Group B | Viral Clearance Day 8 / Positive | 2 | Participants | |
| Anti-Viral Activity of CX-4945 | Group A | Viral Clearance Day 8 / Inconclusive | 2 | Participants | |
| Anti-Viral Activity of CX-4945 | Group B | Viral Clearance Day 8 / Inconclusive | 0 | Participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 10 | |
| Overall Study | STARTED | Group B | 10 | |
| Overall Study | COMPLETED | Group A | 8 | |
| Overall Study | COMPLETED | Group B | 10 | |
| Overall Study | NOT COMPLETED | Group A | 2 | |
| Overall Study | NOT COMPLETED | Group B | 0 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Group A | 0 | 10 | 0 |
| other | Palpitations | Cardiac disorders | Group B | 1 | 10 | 1 |
| other | Photopsia | Eye disorders | Group A | 0 | 10 | 0 |
| other | Photopsia | Eye disorders | Group B | 1 | 10 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Group A | 1 | 10 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Group B | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Group A | 1 | 10 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Group B | 0 | 10 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Group A | 1 | 10 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Group B | 0 | 10 | 0 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 0 | 10 |
| Total, all-cause mortality | Group B | 0 | 10 |
| Total, other adverse events | Group A | 8 | 10 |
| Total, other adverse events | Group B | 4 | 10 |
| Total, serious adverse events | Group A | 1 | 10 |
| Total, serious adverse events | Group B | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A vs Group B: Clinical Benefit of CX-4945 i.e. Number of Subjects Hospitalized in Each Treatment Group From Randomization (Day 1) to Day 45 | Trial comparisons |
| Group A vs Group B: 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 | Trial comparisons |
| Group A vs Group B: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group | Trial comparisons |
| Group A vs Group B: Clinical Benefit of CX-4945 i.e. Number of Respiratory Failures Occurred in Each Treatment Group From Randomization (Day 1) Through Day 45 | Trial comparisons |
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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