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Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects With Recently Diagnosed COVID-19 Compared to Standard of Care Treatment

Trial Profile

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects With Recently Diagnosed COVID-19 Compared to Standard of Care Treatment

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Sep 2020

At a glance

  • Drugs BLD-2660 (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Acronyms BLADE-CONQUER
  • Sponsors Blade Therapeutics
  • Most Recent Events

    • 14 Sep 2020 According to a Blade Therapeutics media release, an independent Data Monitoring Committee (DMC) recommended continuation of the trial without changes after conducting a planned review of blinded safety data.
    • 14 Sep 2020 Status changed from recruiting to active, no longer recruiting according to a Blade Therapeutics media release
    • 14 Sep 2020 According to a Blade Therapeutics media release, it has reached the 120-subject enrollment goal for the Phase 2 clinical study

Trial Overview

Purpose

This study will evaluate BLD-2660 as an add-on therapy to standard of care (SOC) including Remdesivir in hospitalized subjects with recent diagnosis of COVID-19. Patients will be given BLD-2660 twice a day over 10 days.

Primary Endpoints

Time to recovery

description: To evaluate time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first.
time_frame: Course of study; 28 days

Change in oxygenation

description: 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)
time_frame: 10 days

Other Endpoints

Safety & Tolerability: incidence of TEAEs and serious adverse events (SAEs)

description: To evaluate the safety and tolerability of BLD-2660 in the same population. Measured by incidence of TEAEs and serious adverse events (SAEs)
time_frame: Course of study; 28 days

Change in oxygenation

description: To evaluate change in oxygenation while hospitalized & during follow-up visits. Measured by:
Improvement from baseline to Days 10, 14, 21 and 28 as measured by the ratio of hemoglobin oxygen saturation to inspired oxygen fraction (SpO2/FiO2), categorized on the 4-point ordinal scale Time to discontinuation of oxygen supplementation requirement Mean SpO2 for subjects not requiring oxygen supplementation at Days 5, 10, 21 and 28 Number of O2 supplementation free days during hospitalization Proportion of subjects who do not require oxygen supplementation (sustained for at least 24 hours) during hospitalization
time_frame: Course of study; 28 days

Rate of mortality

description: Measured by mortality rate during the 28-day study period following enrollment.
time_frame: Course of study; 28 days

Time to discharge readiness

description: Measured by time to discharge readiness
time_frame: Course of study; 28 days

Proportion of subjects discharged during study

description: Measured by proportion of subjects ready to be discharged from the hospital during the 28-day study period following enrollment.
time_frame: Course of study; 28 days

Proportion of subjects with resolved fever

description: Measured by proportion of subjects with resolution of fever below entry criteria for 24 hours by Day 10 in subjects with fever at baseline
time_frame: 10 days

Time to resolution of fever

description: Measured by time to resolution of fever below entry criteria for 24 hours in subjects with fever at baseline
time_frame: Course of study; 28 days

Duration of Remdesivir use

description: Measured by duration (in days) of remdesivir use in subjects starting remdesivir within 24 hours of first dose of BLD-2660
time_frame: Course of study; 28 days

Change in clinical status

description: Measured by change from baseline to Days 10, 14, 21 and 28 in clinical status outcome using a 6-point ordinal scale
time_frame: Course of study; 28 days

Proportion of subjects in each category of the 6-point ordinal scale

description: Measured by proportion of subjects reporting each 6-point ordinal scale of the clinical status outcome assessment.
time_frame: Course of study; 28 days

Change from in NEWS score

description: Measured by change from baseline to Days 5, 10, 14, 21 and 28 in NEWS score
time_frame: Course of study; 28 days

Change in IL-6

description: Measured by change from baseline to Days 10, 14, 21 and 28 in IL-6 in ng/mL measured by analytical assay
time_frame: Course of study; 28 days

Change in D-dimer

description: Measured by change from baseline to Days 10, 14, 21 and 28 in D-dimer in ng/mL measured by analytical assay
time_frame: Course of study; 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 120

    Actual: 120

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

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. - Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female subjects and male partners of female subjects must continue to use highly effective contraception for 30 days after the last dose of study drug. Female subjects should not donate oocytes during this time. Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days. Male subjects must agree not to donate sperm during this time. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Note: Ethinyl estradiol is the primary estrogen used in hormonal contraceptives. The progestin component consists of norethindrone, levonorgestrel, norgestrel, norethindrone acetate, ethynodiol diacetate, norgestimate, desogestrel, and drospirenone. As BLD-2660 is a weak CYP3A4 inducer, exposure to both the estrogen and progestin components in hormonal contraceptives may be decreased, resulting in an increased risk of pregnancy. As such, it is recommended that subjects who are on hormonal contraceptives for birth control should use an alternate means of contraception (condoms, diaphragms, intrauterine device (IUD), other barrier methods, sexual abstinence, etc.) during participation in the study. Women of childbearing potential must have a negative serum pregnancy test at Screening within 72 hours prior to first administration of study drug. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 1 year Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Patient Exclusion Criteria

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. Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. - Unable to swallow solid oral medication or known malabsorption disorder. - Subjects who have allergy to BLD-2660 or inactive components of BLD-2660.

Trial Details

Identifiers

Identifier Owner
NCT04334460 ClinicalTrials.gov: US National Institutes of Health
B2660-204 -
BLD-2660-204 -

Organisations

  • Sponsors Blade Therapeutics
  • Affiliations Blade Therapeutics

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 04 May 2020

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Oct 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Brazil; USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
BLD-2660Primary Drug Oral
-

Active Group

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

Placebo Group

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jennifer Scott, RN Vanderbilt University Medical Center USA
Joanne Imperial, MD
-
Maria Walters, M.P.H.
(650) 443-7366 mwalters@blademed.com
show details
, Blade Therapeutics
-
Todd Rice, MD Vanderbilt University Medical Center USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Blade Reseach Site San Jose, California USA
Blade Research Site Ames, Iowa USA
Blade Research Site Bahia Brazil
Blade Research Site Baltimore, Maryland USA
Blade Research Site Belo Horizonte Brazil
Blade Research Site Brandon, Florida USA
Blade Research Site Campinas, Sao Paulo Brazil
Blade Research Site Charleston, South Carolina USA
Blade Research Site Dallas, Texas USA
Blade Research Site Detroit, Michigan USA
Blade Research Site Durham, North Carolina USA
Blade Research Site Elmhurst, Illinois USA
Blade Research Site Farmington Hills, Michigan USA
Blade Research Site Fayetteville, North Carolina USA
Blade Research Site Fort Lauderdale, Florida USA
Blade Research Site Fort Pierce, Florida USA
Blade Research Site Idaho Falls, Idaho USA
Blade Research Site Irvine, California USA
Blade Research Site Lexington, Kentucky USA
Blade Research Site Long Beach, California USA
Blade Research Site Los Angeles, California USA
Blade Research Site Louisville, Kentucky USA
Blade Research Site Marietta, Georgia USA
Blade Research Site Naperville, Illinois USA
Blade Research Site Omaha, Nebraska USA
Blade Research Site Panama City, Florida USA
Blade Research Site Peoria, Illinois USA
Blade Research Site Philadelphia, Pennsylvania USA
Blade Research Site Ribeirão Preto Brazil
Blade Research Site Ridgewood, New Jersey USA
Blade Research Site São José Do Rio Preto Brazil
Blade Research Site San Diego, California USA
Blade Research Site Tampa, Florida USA
Blade Research site Towson, Maryland USA
Blade Research Site Valhalla, New York USA
Blade Research Site Vitória Brazil
Blade Research Site Washington, District of Columbia USA
Blade Therapeutics
-
-
Clinipace Worldwide
-
-
Vanderbilt University Medical Center Nashville, Tennessee USA

Trial History

Event Date Event Type Comment
14 Sep 2020 Other trial event According to a Blade Therapeutics media release, an independent Data Monitoring Committee (DMC) recommended continuation of the trial without changes after conducting a planned review of blinded safety data. Updated 17 Sep 2020
14 Sep 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting according to a Blade Therapeutics media release Updated 17 Sep 2020
14 Sep 2020 Other trial event According to a Blade Therapeutics media release, it has reached the 120-subject enrollment goal for the Phase 2 clinical study Updated 17 Sep 2020
04 Sep 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 04 Sep 2020
12 Aug 2020 Other trial event According to a Blade Therapeutics media release, the company expect to complete enrollment in 3Q-2020 and provide topline results in 4Q-2020. Updated 19 Aug 2020
12 Aug 2020 Other trial event According to a Blade Therapeutics media release, this trial has enrolled half of the anticipated 120 coronavirus disease-19 (COVID-19) pneumonia patients. Updated 19 Aug 2020
22 Jul 2020 Other trial event According to a Blade Therapeutics media release, more sites could come online. When the data from this trial will be available is unknown but an interim analysis could occur with 30 to 60 patients. Updated 30 Jul 2020
22 Jul 2020 Other trial event According to a Blade Therapeutics media release, the company its contract research partner Clinipace Worldwide of Morrisville, North Carolina started recruiting people this month into 13 sites California, Florida, Illinois, Idaho, Maryland, Michigan, Mew jersey, North Carolina, Pennsylvania, Tennessee, Texas and Washington. Within 2 months, 25-person Blade filed its data with U.S FDA hoping the drug could not only halt the virus but also arrest hyper-inflammation and reverse lung injury. Updated 30 Jul 2020
22 Jul 2020 Other trial event According to a Blade Therapeutics media release, the company expects to complete this study as soon as this fall. Updated 30 Jul 2020
06 Jul 2020 Completion date Planned End Date changed from 1 Sep 2020 to 1 Oct 2020. Updated 10 Jul 2020
06 Jul 2020 Other trial event Planned primary completion date changed from 1 Aug 2020 to 1 Sep 2020. Updated 10 Jul 2020
06 May 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 11 May 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Blade Therapeutics. Blade Therapeutics Appoints Accomplished Biopharmaceutical Executive, Mark Timney, as Chairman of the Board. Media-Rel 2020;.

    Media Release
  3. Blade Therapeutics. Blade Therapeutics Updates Enrollment Progress for Phase 2 Study of Lead Investigational Therapy BLD-2660 in Treating Patients with COVID-19 Pneumonia. Media-Rel 2020;.

    Media Release
  4. Blade Therapeutics. Blade Therapeutics Reaches Enrollment Goal for Phase 2 Study of Lead Investigational Therapy BLD-2660 in Treating Patients With COVID-19 Pneumonia. Media-Rel 2020;.

    Media Release
  5. Blade Therapeutics. Peninsula biotech preps attaclc on Covid after virus stalls drug in another clinical trial. Media-Rel 2020;.

    Media Release
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