Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects

NCT04334460 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: B-2660-204
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 35

Brief Summary

BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9 that is selective over the cathepsins as well as other protease families, displays good metabolic stability and permeability, oral bioavailability and low cytochrome P450 (CYP) inhibition. It is under development for the treatment of coronavirus disease-19 (COVID-19) resulting from infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV2), where there is significant unmet medical need.

Conditions

Sars-CoV-2; Covid19

Outcome Measures

Primary Outcomes (2)

• Time to Recovery

  To evaluate time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first.

  Course of study; 28 days

• Change in Oxygenation

  To evaluate change in oxygenation in hospitalized adults with COVID-19 treated with BLD-2660. Measured by change from baseline to Day 10 or hospital discharge, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)

  10 days

Secondary Outcomes (1)

• Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)

  Course of study; 28 days

Other Outcomes (8)

• Time to Discharge Readiness

  Course of study; 28 days

• Proportion of Subjects Discharged During Study

  Course of study; 28 days

• Time to Resolution of Fever

  Course of study; 28 days

Study Arms (2)

Active (BLD-2660) Group

ACTIVE COMPARATOR

Drug: BLD-2660

Placebo Group

PLACEBO COMPARATOR

Drug: BLD-2660

Interventions

BLD-2660 DRUG

BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.

Active (BLD-2660) Group; Placebo Group

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of signing the ICF.
• Hospitalized for COVID-19.
• Diagnosed with COVID-19 as defined by having at least 2 of the following signs or symptoms within the past 2 days:
• Fever defined as a body temperature of ≥ 38.0 °C oral, or ≥ 38.3 °C rectal, ≥37.7 °C forehead or ≥38.7°C aural (axillary temperatures are not allowable);
• Cough;
• Fatigue;
• Shortness of breath.
• Radiographic evidence (chest x-ray or CT scan) of one the following:
• Ground-glass opacities, or
• Local or bilateral patchy infiltrates, or
• Interstitial pulmonary infiltrates.
• Oxygen requirements:
• SpO2 ≤ 94% on ambient air OR
• Requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.
• Male and/or female subjects.

You may not qualify if:

• Active bacterial pneumonia infection
• Known active tuberculosis (TB).
• History of Child-Pugh B or C cirrhosis.
• History of ischemic heart disease or myocardial infarction or acute coronary syndrome.
• Subjects requiring supplemental oxygen ≥0.75 FiO2.
• It is not in the best interest of the subjects to participate, in the opinion of the treating Investigator.
• Female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study drug.
• The following laboratory parameters are excluded:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 x upper limit of normal (ULN);
• Creatinine clearance \< 50 mL/min.
• Requiring, or expected to require mechanical ventilation at screening.
• Treatment with chloroquine or hydroxychloroquine at study entry.
• Treatment with anti-IL 6, anti-IL-6 receptor antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period.
• Participation in any other clinical study of an experimental drug treatment for COVID-19 within 6 half-lives of the experimental treatment.
• Note: Subjects participating in an observational study are an exception to this criterion and may qualify for the study with Sponsor approval.

Sponsors & Collaborators

• Blade Therapeutics: lead
• Clinipace Worldwide: collaborator

Study Sites (35)

Blade Research Site

Irvine, California, 92697, United States

Location

Blade Research Site

Los Angeles, California, 90048, United States

Location

Blade Reseach Site

San Jose, California, 95128, United States

Location

Blade Research Site

Washington D.C., District of Columbia, 20007, United States

Location

Blade Research Site

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

Location

Blade Research Site

Brandon, Florida, 33511, United States

Location

Blade Research Site

Ft. Pierce, Florida, 34982, United States

Location

Blade Research Site

Panama City, Florida, 32405, United States

Location

Blade Research Site

Tampa, Florida, 33620, United States

Location

Blade Research Site

Idaho Falls, Idaho, 83404, United States

Location

Blade Research Site

Peoria, Illinois, 61603, United States

Location

Blade Research Site

Ames, Iowa, 50010, United States

Location

Blade Research Site

Lexington, Kentucky, 40503, United States

Location

Blade Research Site

Louisville, Kentucky, 40207, United States

Location

Blade Research Site

Baltimore, Maryland, 21201, United States

Location

Blade Research Site

Detroit, Michigan, 48202, United States

Location

Blade Research Site

Farmington Hills, Michigan, 48334, United States

Location

Blade Research Site

Omaha, Nebraska, 68114, United States

Location

Blade Research Site

Ridgewood, New Jersey, 07450, United States

Location

Blade Research Site

Charleston, North Carolina, 29414, United States

Location

Blade Research Site

Durham, North Carolina, 27708, United States

Location

Blade Research Site

Fayetteville, North Carolina, 28304, United States

Location

Blade Research Site

Philadelphia, Pennsylvania, 19140, United States

Location

Blade Research Site

Charleston, South Carolina, 29414, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Blade Research Site

Dallas, Texas, 75203, United States

Location

Blade Research Site

Spokane, Washington, 99204, United States

Location

Blade Research Site

Campinas, São Paulo, 13034, Brazil

Location

Blade Research Site

Bahia, 41810, Brazil

Location

Blade Research Site

Belo Horizonte, 30150, Brazil

Location

Blade Research Site

Botucatu, 18618, Brazil

Location

Blade Research Site

Porto Velho, 76801, Brazil

Location

Blade Research Site

Ribeirão Preto, 65470, Brazil

Location

Blade Research Site

São José do Rio Preto, 15090, Brazil

Location

Blade Research Site

Vitória, 29041, Brazil

Location

MeSH Terms

Conditions

COVID-19

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: SVP, Global Regulatory Affairs, Quality, and Safety
• Organization: Blade Therapeutics

dmody@blademed.com

(650) 278 4291

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: May 4, 2020
• Primary Completion: November 11, 2020
• Study Completion: June 21, 2021
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-02

Locations

US (27); BR (8)