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

Phase 2

Completed

• Conditions: Acute Lung Injury; COVID-19 Pneumonia; ARDS
• Interventions: Drug: CERC-002; Drug: Placebo

• Registration Number: NCT04412057
• Lead Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Study Start: 2020-07-17
• Primary Completion: 2020-12-14
• Study Completion: 2021-01-19
• Results First Submitted: 2022-02-24
• Results First Submitted QC: 2022-02-24
• Status Verified: 2022-03
• Results First Posted: 2022-03-04
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CERC-002	CERC-002	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Alive and Free of Respiratory Failure	Baseline to Day 28	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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Are Alive at Day 28	Baseline to Day 28	1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit

Trial Locations

Locations (11)

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

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

LSUHSC - Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Carolina Institute for Clinical Research, LLC; 🇺🇸 Fayetteville, North Carolina, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Lowcountry Infectious Diseases, P.A.; 🇺🇸 Charleston, South Carolina, United States

BRCR Global Texas; 🇺🇸 McAllen, Texas, United States

AnMed Health Medical Center; 🇺🇸 Anderson, South Carolina, United States

MedPharmics, LLC; 🇺🇸 Metairie, Louisiana, United States