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

NCT04663737 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-16

Study results available
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Summary

This single-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 20 subjects aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with moderate COVID-19. Two-arm trial comparing the SOC/supportive care alone to the SOC/supportive care with addition of Silmitasertib (allocation ratio 1:1).

Conditions

  • Covid19

Interventions

DRUG

Silmitasertib

Capsules

DRUG

SOC

Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris P. Recknor, MD · Center for Advanced Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-08-16
Completion
2021-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663737 on ClinicalTrials.gov