Bucillamine in Treatment of Patients With COVID-19

Inclusion Criteria:

• Is within 72 hours from onset of symptoms consistent with COVID 19 at time of studyenrollment
• Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness ofbreath, chest x ray changes consistent with COVID-19 at time of screening
• Has peripheral capillary oxygen saturation (SpO2) ≥94 by pulse oximetry at time ofscreening
• Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approvedrapid 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, andnon-invasive oxygen monitoring (via pulse oximeter) per protocol
• Patient (or their legally authorized representative) is willing and able to providewritten 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 1primary form of contraception not including hormonal contraception from the time ofscreening through Day 29 following randomization. All subjects of childbearingpotential, including males with partners of childbearing potential, must use highlyeffective methods of birth control defined as those, alone or in combination, thatresult in a low failure rate (i.e., less than 1 percent per year) when usedconsistently and correctly. Abstinence is NOT an acceptable method of contraceptionUNLESS it is the subject's normal practice.

Exclusion Criteria:

• Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liverdisease, or interstitial pneumonia
• Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) oraspartate transaminase (AST) > 5 times the upper limit of normal (ULN) at screening
• Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronicrenal dysfunction (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73m2according to Cockcroft Gault formula)
• Proteinuria ≥ 1+ or ≥ 30 mg on dipstick urinalysis that is confirmed on repeatassessment 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 limitedto) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g.,cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid useequivalent 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'sdisease, 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