A phase 2 randomized double-blind placebo-controlled study to evaluate safety of BLD-2660 and its activity against COVID-19 virus in hospitalized subjects recently diagnosed with COVID-19 in comparison to standard of care treatment
- Conditions
- new coronavirus infectionviral pneumonia, not elsewhere classifiedC01.925.782.600.550.200
- Registration Number
- RBR-2kjm6y
- Lead Sponsor
- Blade Therapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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: a.fever defined as a body temperature higher than 38.0°C oral, or higher than 38.3°C rectal, higher than 37.7°C forehead or higher than 38.7°C aural (axillary temperatures are not allowable); b.cough; c.fatigue; d.shortness of breath. Radiographic evidence (chest x-ray or CT scan) of one the following: a. ground-glass opacities, or b.local or bilateral patchy infiltrates, or c.interstitial pulmonary infiltrates. Oxygen requirements: a. spO2 higher than 94% on ambient air or b.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. 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
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 higher than 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) higher than 5 x upper limit of normal (ULN); creatinine clearance lower than 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. Current participation or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug. Unable to swallow solid oral medication or known malabsorption disorder. Subjects who have allergy to BLD-2660 or inactive components of BLD-2660
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method