Status:
TERMINATED
Bucillamine in Treatment of Patients With COVID-19
Lead Sponsor:
Revive Therapeutics, Ltd.
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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:...
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:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
713 Patients enrolled
Trial Details
Trial ID
NCT04504734
Start Date
November 27 2020
End Date
June 12 2023
Last Update
July 7 2023
Active Locations (47)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Avant Research Associates, LLC
Huntsville, Alabama, United States, 35802
3
West Valley Research Clinic
Phoenix, Arizona, United States, 85031
4
HealthStar Research LLC
Hot Springs, Arkansas, United States, 71913