CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Silmitasertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04663737
NCT04663737Phase 2Completed

A Phase II, Randomized and Controlled Investigator Initiated Trial Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Outpatient Adult Subjects With Moderate Coronavirus Disease 2019 (COVID-19)

Senhwa Biosciences, Inc.·interventional·Posted Dec 11, 2020·Updated Jan 16, 2025

In Brief

A Phase 2 clinical trial evaluating Silmitasertib and SOC for Covid19. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 11, 2020
Enrollment StartNov 30, 2020
Primary CompletionAug 16, 2021
Study CompletionOct 4, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.6 years ago

Interventions

Silmitasertibdrug

Capsules

SOCdrug

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