Bucillamine in Treatment of Patients With COVID-19

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID: NCT04504734
Run by: Revive Therapeutics, Ltd.
People needed: 713
Starts: 2020-11-27
Expected to finish: 2023-06-12
Last updated by the study team: 2023-07-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is within 72 hours from onset of symptoms consistent with COVID 19 at time of study enrollment
Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness of breath, chest x ray changes consistent with COVID-19 at time of screening
Has peripheral capillary oxygen saturation (SpO2) ≥94 by pulse oximetry at time of screening
Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved rapid diagnostic (e.g., PCR) assay
Has a score of ≤ 2 on the 8-category NIAID ordinal scale at time of screening
Agrees to the collection of blood and urine samples, nasopharyngeal (NP) swabs, and non-invasive oxygen monitoring (via pulse oximeter) per protocol
Patient (or their legally authorized representative) is willing and able to provide written informed consent prior to performing study procedures
Understands and agrees to comply with planned study procedures
Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception not including hormonal contraception from the time of screening through Day 29 following randomization. All subjects of childbearing potential, including males with partners of childbearing potential, must use highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. Abstinence is NOT an acceptable method of contraception UNLESS it is the subject's normal practice.

You may not qualify if…

Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver disease, or interstitial pneumonia
Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper limit of normal (ULN) at screening
Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronic renal dysfunction (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73m2 according to Cockcroft Gault formula)
Proteinuria ≥ 1+ or ≥ 30 mg on dipstick urinalysis that is confirmed on repeat assessment within 24 hours
Serum BUN ≥ 2 × ULN or Cr ≥ 2 × ULN
Leukopenia with absolute granulocyte count < 1500/µL
History of positive Human Immunodeficiency virus (HIV) test or organ transplant
Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone >10 gm/day, during preceding 2 months
Confirmed positive for influenza at screening
Confirmed positive for respiratory syncytial virus (RSV) at screening
Pregnant or breastfeeding
Current use of, or known allergy to bucillamine or penicillamine (e.g., for Wilson's disease, rheumatoid arthritis)
Current participation in any other clinical trial of an experimental treatment
Receipt of any experimental treatment for COVID-19 (herbal/homeopathic, off-label, compassionate use, or trial related) within the 30 days prior to screening

Where it is running

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
Samuel Ross MD Inc. — Los Angeles, California, United States
Amicis Research Center — Northridge, California, United States
Optimus Medical Group — San Francisco, California, United States
C & R Research Services USA — Coral Gables, Florida, United States
Sweet Hope Research Specialty Inc — Hialeah, Florida, United States
Encore Medical Research — Hollywood, Florida, United States
Entrust Clinical Research — Kendall, Florida, United States
Columbus Clinical Services — Miami, Florida, United States
Verus Clinical Research — Miami, Florida, United States
Nuren Medical & Research Center — Miami, Florida, United States
Advance Medical Research Services Corp — Miami, Florida, United States
Amavita Clinical Research — North Miami Beach, Florida, United States
C & R Research Services USA — Tampa, Florida, United States
Encore Medical Research of Weston LLC — Weston, Florida, United States
Clinical Site Partners LLC — Winter Park, Florida, United States
American Clinical Trials LLC — Acworth, Georgia, United States
Quad Clinical Research LLC — Chicago, Illinois, United States
Koch Family Medicine — Morton, Illinois, United States
Revive Research Institute Inc. — Farmington Hills, Michigan, United States
SRI International — Plymouth, Michigan, United States

Full record on ClinicalTrials.gov

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