Bucillamine in Treatment of Patients With COVID-19

NCT ID: NCT04504734

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 713 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-27
• Study Completion Date: 2023-06-12

Brief Summary

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.

Detailed Description

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bucillamine low dose

Bucillamine 100 mg 3 times a day (TID)

Group Type: ACTIVE_COMPARATOR

Bucillamine

Intervention Type: DRUG

100mg tablets

Bucillamine high dose

Bucillamine 200 mg 3 times a day (TID)

Group Type: ACTIVE_COMPARATOR

Bucillamine

Intervention Type: DRUG

200mg tablets

Placebo

Placebo, 3 times a day (TID)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

100mg tablets

Interventions

Bucillamine

100mg tablets

Intervention Type: DRUG

Placebo

100mg tablets

Intervention Type: DRUG

Bucillamine

200mg tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revive Therapeutics, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Great Lakes Research Institute

Southfield, Michigan, United States

Revival Research Institute LLC

Sterling, Michigan, United States

Machuca Family Medicine

Las Vegas, Nevada, United States

Prime Global Research

The Bronx, New York, United States

OnSite Clinical Solutions

Charlotte, North Carolina, United States

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Superior Clinical Research

Smithfield, North Carolina, United States

Superior Clinical Research

Yanceyville, North Carolina, United States

Dayton Clinical Research

Dayton, Ohio, United States

Pharmacorp Clinical Trials Inc.

Charleston, South Carolina, United States

Novaceut Clinical Research

Clarksville, Tennessee, United States

Physicians Quality Care

Jackson, Tennessee, United States

Inquest Clinical Research

Baytown, Texas, United States

C & R Research Services USA

Houston, Texas, United States

Encore Imaging and Medical Research

Houston, Texas, United States

R & H Clinical Research Inc.

Katy, Texas, United States

FMC Science

Lampasas, Texas, United States

Family Practice Center

McAllen, Texas, United States

R & H Clinical Research Inc.

Stafford, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

Dr. Orvil Martínez-Rivera

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

RT-003

Identifier Type: -

Identifier Source: org_study_id