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

Completed · Phase 2

Conditions studied: Covid19

In brief

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).

Key facts

Study ID: NCT04663737
Run by: Senhwa Biosciences, Inc.
People needed: 20
Starts: 2020-11-30
Expected to finish: 2021-10-04
Last updated by the study team: 2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or non-pregnant female adult ≥ 18 years of age
Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing
Outpatient subjects with moderate illness caused by SARS-CoV-2 infection as defined below,
Symptoms of moderate systemic illness/infection with COVID-19:
At least two of the key COVID-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion
AND
Clinical signs indicative of moderate systemic illness/infection with COVID-19 At least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute
AND
No clinical signs indicative of Severe or Critical Illness Severity required hospitalization (see exclusion criterion #1)
Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Adequate hematopoietic capacity, as defined by the following:
Hemoglobin ≥ 9.0 g/dL and not transfusion dependent
Platelets ≥ 100,000/mm3
Absolute neutrophil count ≥ 1500 cells/mm3
Adequate hepatic function, as defined by the following:
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x ULN
Albumin ≥ 3.0 g/dL
Adequate renal function, as defined by the following:
a. Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased creatinine levels (Cockcroft-Gault formula).
Ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see Section 6.3) throughout study duration.

You may not qualify if…

Any signs indicative of Severe or Critical Illness Severity required hospitalization as defined below:
Severe COVID-19: Shortness of breath in rest, or respiratory distress, respiratory rate (RR) >/= 30 per minute, heart rate (HR) >/=125 bpm, SpO2</=93% on room air at sea level or PaO2/FiO2<300
Critical COVID-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, ESMO; shock or multi-organ dysfunction/failure
Pregnant or nursing women. (NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.)
Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment
Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
Concomitant treatment with another investigational drug from Day 1 through Day 28.
Current use or anticipated need for drugs that are known strong inhibitors or inducers of major CYP enzymes.

Where it is running

Center for Advanced Research and Education — Gainesville, Georgia, United States

Full record on ClinicalTrials.gov

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