Bucillamine in Treatment of Patients With COVID-19

NCT04504734 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: RT-003
• Study Type: interventional
• Target: 713
• Locations: 2 countries
• Sites: 47

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Efficacy: Frequency of hospitalization or death

  Proportion of patients meeting a composite endpoint of hospitalization or death

  From time of first dose through Day 28 following randomization

Secondary Outcomes (1)

• Safety: Changes in adverse events from baseline to end of study

  From time of first dose through Day 28 following randomization

Study Arms (3)

Bucillamine low dose

ACTIVE COMPARATOR

Bucillamine 100 mg 3 times a day (TID)

Drug: Bucillamine

Bucillamine high dose

ACTIVE COMPARATOR

Bucillamine 200 mg 3 times a day (TID)

Drug: Bucillamine

Placebo

PLACEBO COMPARATOR

Placebo, 3 times a day (TID)

Drug: Placebo

Interventions

Bucillamine DRUG

100mg tablets

Bucillamine low dose

Placebo DRUG

100mg tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Revive Therapeutics, Ltd.: lead

Study Sites (47)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Avant Research Associates, LLC

Huntsville, Alabama, 35802, United States

Location

West Valley Research Clinic

Phoenix, Arizona, 85031, United States

Location

HealthStar Research LLC

Hot Springs, Arkansas, 71913, United States

Location

ASCADA Research

Huntington Beach, California, 92648, United States

Location

Samuel Ross MD Inc.

Los Angeles, California, 90035, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

C & R Research Services USA

Coral Gables, Florida, 33134, United States

Location

Sweet Hope Research Specialty Inc

Hialeah, Florida, 33016, United States

Location

Encore Medical Research

Hollywood, Florida, 33021, United States

Location

Entrust Clinical Research

Kendall, Florida, 33156, United States

Location

Columbus Clinical Services

Miami, Florida, 33125, United States

Location

Verus Clinical Research

Miami, Florida, 33125, United States

Location

Nuren Medical & Research Center

Miami, Florida, 33144, United States

Location

Advance Medical Research Services Corp

Miami, Florida, 33165, United States

Location

Amavita Clinical Research

North Miami Beach, Florida, 33169, United States

Location

C & R Research Services USA

Tampa, Florida, 33614, United States

Location

Encore Medical Research of Weston LLC

Weston, Florida, 33321, United States

Location

Clinical Site Partners LLC

Winter Park, Florida, 32789, United States

Location

American Clinical Trials LLC

Acworth, Georgia, 30101, United States

Location

Quad Clinical Research LLC

Chicago, Illinois, 60643, United States

Location

Koch Family Medicine

Morton, Illinois, 61550, United States

Location

Revive Research Institute Inc.

Farmington Hills, Michigan, 48334, United States

Location

SRI International

Plymouth, Michigan, 48170, United States

Location

Great Lakes Research Institute

Southfield, Michigan, 48075, United States

Location

Revival Research Institute LLC

Sterling, Michigan, 48312, United States

Location

Machuca Family Medicine

Las Vegas, Nevada, 89104, United States

Location

Prime Global Research

The Bronx, New York, 10456, United States

Location

OnSite Clinical Solutions

Charlotte, North Carolina, 28208, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28277, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Superior Clinical Research

Smithfield, North Carolina, 27577, United States

Location

Superior Clinical Research

Yanceyville, North Carolina, 27379, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Pharmacorp Clinical Trials Inc.

Charleston, South Carolina, 29412, United States

Location

Novaceut Clinical Research

Clarksville, Tennessee, 37043, United States

Location

Physicians Quality Care

Jackson, Tennessee, 38305, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

C & R Research Services USA

Houston, Texas, 77022, United States

Location

Encore Imaging and Medical Research

Houston, Texas, 77065, United States

Location

R & H Clinical Research Inc.

Katy, Texas, 77494, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

Family Practice Center

McAllen, Texas, 78501, United States

Location

R & H Clinical Research Inc.

Stafford, Texas, 77477, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

Dr. Orvil Martínez-Rivera

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

COVID-19

Interventions

bucillamine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: November 27, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

US (46); PR (1)