Bucillamine in Treatment of Patients With COVID-19

Covid19 Clinical Trial

Official title:

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04504734
• Other study ID #: RT-003
• Status: Terminated
• Phase: Phase 3
• Start date: November 27, 2020
• Est. completion date: June 12, 2023

Study information

• Verified date: July 2023
• Source: Revive Therapeutics, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 713
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Bucillamine
100mg tablets
• Placebo
100mg tablets
• Bucillamine
200mg tablets

Locations

Country	Name	City	State
Puerto Rico	Dr. Orvil Martínez-Rivera	San Juan
United States	American Clinical Trials LLC	Acworth	Georgia
United States	Inquest Clinical Research	Baytown	Texas
United States	Prime Global Research	Bronx	New York
United States	Pharmacorp Clinical Trials Inc.	Charleston	South Carolina
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Quad Clinical Research LLC	Chicago	Illinois
United States	Novaceut Clinical Research	Clarksville	Tennessee
United States	C & R Research Services USA	Coral Gables	Florida
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Dayton Clinical Research	Dayton	Ohio
United States	Revive Research Institute Inc.	Farmington Hills	Michigan
United States	Sweet Hope Research Specialty Inc	Hialeah	Florida
United States	Encore Medical Research	Hollywood	Florida
United States	HealthStar Research LLC	Hot Springs	Arkansas
United States	C & R Research Services USA	Houston	Texas
United States	Encore Imaging and Medical Research	Houston	Texas
United States	ASCADA Research	Huntington Beach	California
United States	Avant Research Associates, LLC	Huntsville	Alabama
United States	Physicians Quality Care	Jackson	Tennessee
United States	R & H Clinical Research Inc.	Katy	Texas
United States	Entrust Clinical Research	Kendall	Florida
United States	FMC Science	Lampasas	Texas
United States	Machuca Family Medicine	Las Vegas	Nevada
United States	Samuel Ross MD Inc.	Los Angeles	California
United States	Family Practice Center	McAllen	Texas
United States	Advance Medical Research Services Corp	Miami	Florida
United States	Columbus Clinical Services	Miami	Florida
United States	Nuren Medical & Research Center	Miami	Florida
United States	Verus Clinical Research	Miami	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Koch Family Medicine	Morton	Illinois
United States	Amavita Clinical Research	North Miami Beach	Florida
United States	Amicis Research Center	Northridge	California
United States	West Valley Research Clinic	Phoenix	Arizona
United States	SRI International	Plymouth	Michigan
United States	Optimus Medical Group	San Francisco	California
United States	Superior Clinical Research	Smithfield	North Carolina
United States	Great Lakes Research Institute	Southfield	Michigan
United States	R & H Clinical Research Inc.	Stafford	Texas
United States	Revival Research Institute LLC	Sterling	Michigan
United States	C & R Research Services USA	Tampa	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	Encore Medical Research of Weston LLC	Weston	Florida
United States	Clinical Site Partners LLC	Winter Park	Florida
United States	Superior Clinical Research	Yanceyville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Revive Therapeutics, Ltd.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety: Changes in adverse events from baseline to end of study	Number of adverse events	From time of first dose through Day 28 following randomization