Trial · NCT04668209

Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)

NCT04668209, Phase 2, Terminated, University of Arizona; results first posted 2023-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19). Trials, record NCT04668209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04668209

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
NCT number: NCT04668209
Status: Terminated
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: University of Arizona
Conditions: Coronavirus
Interventions: Silmitasertib
First posted: 2020-12-16
Last updated: 2023-11-07
Results first posted: 2023-08-14
Limitations and caveats: After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.

Source ClinicalTrials.gov

Registered outcomes23

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]	Through Day 60	Adverse Events experienced by the patients from randomization to Day 60 (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.
Secondary	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through Day 28	Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours.
Secondary	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through hospital discharge, an average of 28 days	Number of days from randomization to normalization of fever (defined as \<36.6°C from axillary site, or \< 37.2°C from oral site or \< 37.8°C from rectal or tympanic site), normalization of respiratory rate (\< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours.
Secondary	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through Day 28	Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
Secondary	To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.	Assessed on Day 14 and Day 28	Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28.
Secondary	To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.	Through Day 28	Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities)
Secondary	To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.	Assessed at Day 1, Day 8, Day 14 and Day 28	Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28.
Secondary	To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.	Through Day 14	Changes in chest imaging from Screening to Day 5 or 14
Secondary	Number of Days Hospitalized	Through Day 28	Days of hospitalization from randomization through Day 28
Secondary	To Evaluate Changes in IL-6 Level	Assessed on Days 1, 4, 8, 11, and 14	IL-6 level

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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]	Through Day 60	Intent to treat population (all participants assigned to Silmitasertib/Combo, or Standard of Care). The median treatment duration of Silmitasertib was 14 days. The treatment Durations (days) = the last administration date - the first administration.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through Day 28		Days	MEAN
SECONDARY	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through hospital discharge, an average of 28 days		Days	MEAN
SECONDARY	To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Through Day 28		Days	MEAN
SECONDARY	To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.	Assessed on Day 14 and Day 28		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.	Through Day 28	Missing data explains the discrepancy in the total analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.	Assessed at Day 1, Day 8, Day 14 and Day 28	Missing data explains the discrepancy in the total analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.	Through Day 14	No data collected for this outcome analysis.
SECONDARY	Number of Days Hospitalized	Through Day 28		Days	MEAN
SECONDARY	To Evaluate Changes in IL-6 Level	Assessed on Days 1, 4, 8, 11, and 14	Missing data explains the discrepancy in the total analyzed.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group362

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]	Silmitasertib (CX-4945) in Combination With Standard of Care	Experienced Incidence of Treatment Emergent Adverse Events	10		Participants
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	Standard of Care	Experienced Incidence of Treatment Emergent Adverse Events	7		Participants
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	Silmitasertib (CX-4945) in Combination With Standard of Care	Did not experience Incidence of Treatment Emergent Adverse Events	5		Participants
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	Standard of Care	Did not experience Incidence of Treatment Emergent Adverse Events	7		Participants
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Silmitasertib		3	Standard Deviation 1.5	Days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Standard of Care		3.4	Standard Deviation 1.3	Days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Silmitasertib (CX-4945) in Combination With Standard of Care		6	Standard Deviation 4.1	Days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Standard of Care		5.1	Standard Deviation 2.9	Days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Silmitasertib (CX-4945) in Combination With Standard of Care		7.3	Standard Deviation 4.6	Days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.	Standard of Care		6	Standard Deviation 3.3	Days

1 to 10 of 362Source ClinicalTrials.gov

See all 362 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Silmitasertib (CX-4945) in Combination With Standard of Care	15
Overall Study	STARTED	Standard of Care	14
Overall Study	COMPLETED	Silmitasertib (CX-4945) in Combination With Standard of Care	8
Overall Study	COMPLETED	Standard of Care	6
Overall Study	NOT COMPLETED	Silmitasertib (CX-4945) in Combination With Standard of Care	7
Overall Study	NOT COMPLETED	Standard of Care	8

Source ClinicalTrials.gov

Adverse events70

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
other	Thrombocytopenia	Blood and lymphatic system disorders	Silmitasertib (CX-4945) in Combination With Standard of Care	0	15
other	Thrombocytopenia	Blood and lymphatic system disorders	Standard of Care	1	14
other	Premature atrial contractions	Cardiac disorders	Silmitasertib (CX-4945) in Combination With Standard of Care	0	15
other	Premature atrial contractions	Cardiac disorders	Standard of Care	1	14
other	Bloody diarrhea	Gastrointestinal disorders	Silmitasertib (CX-4945) in Combination With Standard of Care	1	15
other	Bloody diarrhea	Gastrointestinal disorders	Standard of Care	0	14
other	Constipation	Gastrointestinal disorders	Silmitasertib (CX-4945) in Combination With Standard of Care	1	15
other	Constipation	Gastrointestinal disorders	Standard of Care	0	14
other	Diarrhea	Gastrointestinal disorders	Silmitasertib (CX-4945) in Combination With Standard of Care	4	15
other	Diarrhea	Gastrointestinal disorders	Standard of Care	2	14

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Silmitasertib (CX-4945) in Combination With Standard of Care	2	15
Total, all-cause mortality	Standard of Care	2	14
Total, other adverse events	Silmitasertib (CX-4945) in Combination With Standard of Care	10	15
Total, other adverse events	Standard of Care	7	14
Total, serious adverse events	Silmitasertib (CX-4945) in Combination With Standard of Care	3	15
Total, serious adverse events	Standard of Care	2	14

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Silmitasertib (CX-4945) in Combination With Standard of Care vs Standard of Care: deaths from any cause	Trial comparisons
Silmitasertib (CX-4945) in Combination With Standard of Care vs Standard of Care: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04668209

GET https://conductscience.org/api/trials/v1/NCT04668209/registered?page=2

API reference For AI assistants