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.
Drug: CERC-002
Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
Other Name: AEVI-002 and MDGN-002
Drug: Placebo
Administered once subcutaneously
Inclusion Criteria:
1. Subject/legally authorized representative (LAR) is able to understand and provide
written informed consent, and assent (as applicable) to participate in this study.
2. Subject is ≥18 years of age at the time of informed consent and assent (as
applicable).
3. Subject is male or non-pregnant, non-lactating female, who if of childbearing
potential agrees to comply with any applicable contraceptive requirements if.
discharged from the hospital prior to completing the study.
4. Subject has a diagnosis of COVID-19 infection through an approved testing method.
5. Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung
injury defined as diffuse bilateral radiographic infiltrates with partial pressure of
arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) >100 and <300.
6. Subject's oxygen saturation at rest in ambient air <93%
Exclusion Criteria:
1. Subject is intubated.
2. Subject is currently taking immunomodulators or anti-rejection drugs.
3. Subject has been administered an immunomodulating biologic drug within 60 days of
baseline.
4. Subject is in septic shock defined as persistent hypotension requiring vasopressors to
maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level
greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
5. Subject has received any live attenuated vaccine, such as varicella-zoster, oral
polio, or rubella, within 3 months prior to the baseline visit.
Hoag Memorial Hospital
Newport Beach, California, United States
Midway Immunology and Research Center
Fort 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
BRCR Global Texas
McAllen, Texas, United States
Scott White, MD, Study Director
Aevi Genomic Medicine, LLC, a Cerecor company