Status:
COMPLETED
Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19
Lead Sponsor:
Senhwa Biosciences, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Silmita...
Detailed Description
Silmitasertib is a first-in-class small molecule drug that targets Casein Kinase 2 (CK2). Protein kinase CK2 phosphorylates key proteins required to trigger mechanisms vital for viral replication and ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04663737
Start Date
November 30 2020
End Date
October 4 2021
Last Update
January 16 2025
Active Locations (1)
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1
Center for Advanced Research and Education
Gainesville, Georgia, United States, 30501