The study is a prospective, randomized, placebo-controlled, double-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a receptor expressed by T lymphocytes), for the treatment of patients with 2019 novel coronavirus disease (COVID-19) pneumonia who have mild to moderate Acute Respiratory Distress Syndrome (ARDS). LIGHT is a cytokine in the tumor necrosis factor super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Hoag Memorial Hospital
Newport Beach, California, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Parkview Research Center
Fort Wayne, Indiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
LSUHSC - Shreveport
Shreveport, Louisiana, United States
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, United States
...and 1 more locations
Number of Subjects Alive and Free of Respiratory Failure
Respiratory failure defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation, * Extracorporeal membrane oxygenation
Time frame: Baseline to Day 28
Number of Subjects Who Are Alive at Day 28
1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit
Time frame: Baseline to Day 28
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