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

NCT04668209 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-11-07

Study results available
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Summary

This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).

Conditions

  • Coronavirus

Interventions

DRUG

Silmitasertib

Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day.

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    collaborator INDUSTRY

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2022-06-30
Completion
2022-10-19
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 NCT04668209 on ClinicalTrials.gov