new coronavirus infection
Conditions
Interventions
Clinical safety/efficacy, randomized, double-blinded, phase 2 trial of placebo versus BLD-2660. It will be included 120 patients of both sexes aged 18 years or older. Control group: 40 patients will t
Drug
Sponsors
Blade Therapeutics Inc
Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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: 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first ;To evaluate the change in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2) from baseline to Day 10 or hospital discharge, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time to hospital discharge readiness;To evaluate the proportion of subjects ready to be discharged from the hospital during the 28-day study period following enrollment;To evaluate the proportion of subjects with resolution of fever below entry criteria for 24 hours by Day 10 in subjects with fever at baseline;To evaluate the time to resolution of fever below entry criteria for 24 hours in subjects with fever at baseline;To evaluate the duration (in days) of remdesivir use in subjects starting remdesivir within 24 hours of first dose of BLD-2660;To evaluate the change from baseline to Days 10, 14, 21 and 28 in clinical status outcome using a 6-point ordinal scale;To evaluate the proportion of subjects reporting each 6-point ordinal scale of the clinical status outcome assessment;To evaluate the change in NEWS score from baseline to Days 5, 10, 14, 21 and 28 ;To evaluate the change from baseline to Days 10, 14, 21 and 28 in IL-6 and D-dimer ;To evaluate the proportion of subjects who require mechanical ventilation after study entry;It is expected to verify reduction in the number of ventilator-free days to Day 21;To evaluate the proportion of subjects with ICU transfer and/or ventilator dependence during the 28-day study period following enrollment ;To evaluate the the time to reach a NEWS of less than or equal to 2 and maintained for 24 hours;To evaluate the change in NEWS from baseline to Days 3, 5, 8, 10, 14, 21 and 28 ;To evaluate the proportion of subjects who are SARS-CoV-2 virus free by Day 10/EOT or hospital discharge, whichever is sooner;To evaluate the time to eradication of SARS-CoV-2;To evaluate the change in SARS-CoV-2 viral load from baseline at Days 5, 10, 14, and 28 ;It is expected to verify reduction in the clinically relevant changes from baseline in electrocardiogram (ECG), and clinical laboratory values at each post baseline timepoint;To evaluate the proportion of subjects with clinically significant drug-related troponin elevation | — |
Countries
Brazil, United States
Contacts
Public ContactDaniela Garcia
Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW
Outcome results
None listed