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

NCT04663737 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CX4945 AV01-IIT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Covid19

Keywords

Moderate Covid19

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Within the CX-4945 Treatment Group

  To assess adverse events associated with the administration of CX-4945 orally, twice daily to patients with moderate COVID-19. The occurrence of overall AEs in the two treatment groups are summarized.

  From randomization (Day 1) to Day 60

Secondary Outcomes (18)

• Clinical Recovery Associated With COVID-19 Within the CX-4945 Treatment Group

  First 14 days of the study.

• Anti-Viral Activity of CX-4945

  Quantitative changes in viral load from Day 1 to Day 28.

• Maximum Plasma Concentration [Cmax] of CX-4945

  Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

• Time to Maximum Observed Plasma Concentration [Tmax] of CX-4945

  Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

• Area Under the Concentration-Time Curve [AUC0-6] of CX-4945

  Plasma sample of CX-4945 are collected at the following timepoints: Day 1: pre-dose, 1, 2, 3, 6 and 24 hours post Day 1 morning dose and Day 14: pre-dose, 1, 2, 3, 6, 24, 48 and 72 hours post Day 14 morning dose.

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive the best supportive care and/or recommended standard of care (at this point no standard of care drugs are recommended by CDC for patients with moderate COVID-19) in combination with the study drug Silmitasertib

Drug: Silmitasertib

Group B

ACTIVE COMPARATOR

Group B (control) that will receive the same care as the Group A but without Silmitasertib

Drug: SOC

Interventions

Silmitasertib DRUG

Capsules

Also known as: CX-4945

Group A

SOC DRUG

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

Also known as: SOC/ Best Supportive Care

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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)

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.

Sponsors & Collaborators

• Senhwa Biosciences, Inc.: lead

Study Sites (1)

Center for Advanced Research and Education

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

silmitasertib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Kacy Huang, Director of Clinical Department
• Organization: Senhwa Biosciences, Inc.

kacyhuang@senhwabio.com

+886-2-8911-9856

Study Officials

• Chris P. Recknor, MD

  Center for Advanced Research and Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: November 30, 2020
• Primary Completion: August 16, 2021
• Study Completion: October 4, 2021
• Last Updated: January 16, 2025
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)