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Bucillamine in Treatment of Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504734
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Revive Therapeutics, Ltd.

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 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. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Bucillamine Drug: Placebo Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo controlled
Primary Purpose: Treatment
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 : May 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: Bucillamine low dose
Bucillamine 100 mg 3 times a day (TID)
Drug: Bucillamine
100mg tablets

Active Comparator: Bucillamine high dose
Bucillamine 200 mg 3 times a day (TID)
Drug: Bucillamine
200mg tablets

Placebo Comparator: Placebo
Placebo, 3 times a day (TID)
Drug: Placebo
100mg tablets




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, California
Samuel Ross MD Inc.
Beverly Hills, California, United States, 90211
ASCADA Research
Huntington Beach, California, United States, 92648
United States, Florida
C & R Research Services USA
Coral Gables, Florida, United States, 33134
Encore Medical Research
Hollywood, Florida, United States, 33021
Columbus Clinical Services
Miami, Florida, United States, 33125
Verus Clinical Research
Miami, Florida, United States, 33125
Amavita Clinical Research
North Miami Beach, Florida, United States, 33169
Encore Medical Research of Weston LLC
Weston, Florida, United States, 33321
United States, Illinois
Quad Clinical Research LLC
Chicago, Illinois, United States, 60643
United States, Nevada
Machuca Family Medicine
Las Vegas, Nevada, United States, 89104
United States, North Carolina
OnSite Clinical Solutions
Charlotte, North Carolina, United States, 28208
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States, 28277
United States, Texas
Encore Imaging and Medical Research
Houston, Texas, United States, 77065
Family Practice Center
McAllen, Texas, United States, 78501
Sponsors and Collaborators
Revive Therapeutics, Ltd.
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Responsible Party: Revive Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT04504734    
Other Study ID Numbers: RT-003
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bucillamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents