This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Patients qualifying for study enrollment will initiate therapy as outpatients, under home quarantine. Patients will receive continued standard care of therapy (per study site written policies or guidelines) together with bucillamine and/ or matching placebo for up to 14 days. Dosing should continue until the treatment course is completed or as medically indicated (e.g., deterioration of clinical status and alternative therapy required). If the patient requires hospitalization during the study period, treatment will be discontinued. Following completion of the treatment course, follow up assessments will be performed by a study nurse 14, 28, 42, and 60 days following the end of treatment. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
713
Cullman Clinical Trials
Cullman, Alabama, United States
Avant Research Associates, LLC
Huntsville, Alabama, United States
West Valley Research Clinic
Phoenix, Arizona, United States
HealthStar Research LLC
Hot Springs, Arkansas, United States
ASCADA Research
Huntington Beach, California, United States
Efficacy: Frequency of hospitalization or death
Proportion of patients meeting a composite endpoint of hospitalization or death
Time frame: From time of first dose through Day 28 following randomization
Safety: Changes in adverse events from baseline to end of study
Number of adverse events
Time frame: From time of first dose through Day 28 following randomization
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Samuel Ross MD Inc.
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Optimus Medical Group
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C & R Research Services USA
Coral Gables, Florida, United States
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Hialeah, Florida, United States
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