Bucillamine in Treatment of Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04504734|
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2020
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Bucillamine Drug: Placebo||Phase 3|
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 2:1 to the selected bucillamine dose or placebo The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 10 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 (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double-blind, placebo controlled|
|Official Title:||Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19|
|Actual Study Start Date :||November 27, 2020|
|Estimated Primary Completion Date :||July 25, 2021|
|Estimated Study Completion Date :||August 25, 2021|
Active Comparator: Bucillamine low dose
Bucillamine 100 mg 3 times a day (TID)
Active Comparator: Bucillamine high dose
Bucillamine 200 mg 3 times a day (TID)
Placebo Comparator: Placebo
Placebo, 3 times a day (TID)
- Efficacy: Frequency of hospitalization or death [ Time Frame: From time of first dose through Day 28 following randomization ]Proportion of patients meeting a composite endpoint of hospitalization or death
- Safety: Changes in adverse events from baseline to end of study [ Time Frame: From time of first dose through Day 28 following randomization ]Number of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504734