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NCT04668209 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Arizona.

Terminated
Registry status
Phase 2
Development phase
31
Enrollment target

NCT04668209: Clinical Trial Phase 2 study, sponsored by University of Arizona.

NCT04668209 is a Phase 2 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04668209, a Phase 2 study, was terminated before completion, sponsored by University of Arizona.

TERMINATED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study 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).

Primary Outcome

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.

Interventions

  • DRUG Silmitasertib

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2021-01-21
Est. Completion 2022-10-19
Phase Phase 2
University of Arizona

349 total trials

Why NCT04668209 stopped before completion

NCT04668209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Silmitasertib is the first listed.

NCT04668209 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04668209 about?

NCT04668209 is a clinical study titled "Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)". 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 ...

What is the current status of trial NCT04668209?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2021-01-21. Estimated completion is 2022-10-19.

What interventions are being tested in trial NCT04668209?

The interventions under investigation include: Silmitasertib (DRUG).

Who is sponsoring clinical trial NCT04668209?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04668209's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04668209, the US trial registry maintained by the National Library of Medicine. NCT04668209 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.