Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19 Pneumonia, Acute Lung Injury, ARDS

In brief

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.

Key facts

Study ID: NCT04412057
Run by: Aevi Genomic Medicine, LLC, a Cerecor company
People needed: 88
Starts: 2020-07-17
Expected to finish: 2021-01-19
Last updated by the study team: 2022-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.
Subject is ≥18 years of age at the time of informed consent and assent (as applicable).
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.
Subject has a diagnosis of COVID-19 infection through an approved testing method.
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.
Subject's oxygen saturation at rest in ambient air <93%

You may not qualify if…

Subject is intubated.
Subject is currently taking immunomodulators or anti-rejection drugs.
Subject has been administered an immunomodulating biologic drug within 60 days of baseline.
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.
Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.

Where it is running

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
BRCR Global Texas — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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