Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19

NCT05164120 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MedStar-COVID-19-belnacasan
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this trial is to assess the safety, tolerability and treatment effect of the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild to moderate COVID-19 and to generate proof of concept for future trials.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Belnacasan

  Number of adverse events and serious adverse events

  Through 60 days post enrollment

Secondary Outcomes (20)

• Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms

  Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization

• Sustained Improvement of Global Impression Rates

  Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization

• Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms

  Over 60 days post randomization

• Time to Sustained Improvement of Global Impression

  Over 60 days post randomization

• Rates of Fever

  Days between enrollment and day 2 post randomization

Study Arms (2)

Interventional

EXPERIMENTAL

900mg dose TID Administration Total: 2700mg

Drug: Belnacasan

Placebo

PLACEBO COMPARATOR

0 mg dose TID Administration Total: 0 mg

Drug: Placebo

Interventions

Belnacasan DRUG

Oral administration

Interventional

Placebo DRUG

Tablet containing 0mg of API

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject (or legally authorized representative) provides written informed consent prior to the initiation of any study procedures
• Subject understands and agrees to comply with planned study procedures, including using the diary
• Subject agrees to the collection of nasopharyngeal swabs and venous blood per protocol
• Subject is male or non-pregnant female adult ≥18 years of age at time of consent
• a. Women with a history of menstruation must agree to use two methods of contraception, at least one of which is highly effective, for the duration of the study as well as to undergo additional pregnancy testing during the study
• Subject has a laboratory confirmed SARS-CoV-2 infection as determined by RT-PCR assay prior to enrollment
• Subject has evidence of either mild or moderate COVID-19 illness of less than 7 days from first onset, with minimal baseline symptom severity based on patient-reported FDA scoring system defined as follows:
• Subject presents with at least two common symptoms of COVID-19 from the following list: Stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath with exertion (without supplemental oxygen requirement) with a score of 2 or higher, impairment in sense of smell or taste with a score of 1 or higher OR
• Subject presents with any (i.e., at least one) symptom of COVID-19 as defined above AND clinical evidence of moderate COVID-19 as defined by FDA guidance for industry (such as respiratory rate \>20 breaths per minute, heart rate \>90 beats per minute, with oxygen saturation \>93% on room air at sea level)
• Subject presents with high-risk for COVID-19-related inflammation determined by at least one comorbidity, including obesity, diabetes, hypertension, stable heart disease, respiratory disease, and/or non-severe fatty liver disease
• Subject's overall health condition is deemed as suitable to fully and safely participate in this trial as determined by the investigator

You may not qualify if:

• Any clinical signs indicative of severe or critical COVID-19 as defined by FDA guidance for Industry at the time, including SpO2 \<93% and/or oxygen requirement
• Hospitalization for COVID-19, or consideration thereof
• ICU level of care and/or non-mechanical/mechanical ventilation and/or oxygen supplementation at time of enrollment
• Pregnant or breast-feeding subjects
• Subjects who cannot swallow tablets
• History of any pre-existing organ impairment, such as:
• Severe kidney disease (known or estimated GFR \<30 mL/minute) or on dialysis
• Uncontrolled, clinically significant heart diseases such as arrhythmias, angina or heart failure as defined by AHA/ACC Grade C and D
• Chronic respiratory disease requiring supplemental oxygen
• Moderate and severe hepatic impairment as defined by Child-Pugh scoring Class B and Class C
• Elevated liver function test (determined by ALT, AST, GGT, or ALP \>2x upper limit of normal, and/or total Bilirubin \> upper limit of normal)
• History of malignancy or immunodeficiency within the prior 5 years
• Acute respiratory illness other than COVID-19
• Acute bacterial, viral or fungal infection (including HIV, hepatitis B, hepatitis C)
• While dosed with IP, the taking of prohibited concomitant medication or the ingestion of food that interferes with the IP, including:

Sponsors & Collaborators

• MedStar Health: lead

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Franklin Square

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

belnacasan

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: Alexander Kroemer, MD; Khalid Kahn, MD
• Organization: MedStar Health Georgetown Transplant Institute

Alexander.Kroemer@gunet.georgetown.edu; Khalid.M.Khan@gunet.georgetown.edu

202-444-3700

Study Officials

• Glenn Wortmann, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomizations, assigned 1:1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 20, 2021
• Study Start: December 14, 2021
• Primary Completion: July 18, 2022
• Study Completion: October 11, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (2)