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

ARDS Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412057
• Other study ID #: CERC-002-CVID-201
• Status: Completed
• Phase: Phase 2
• Start date: July 17, 2020
• Est. completion date: January 19, 2021

Study information

• Verified date: March 2022
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 19, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• COVID-19
• COVID-19 Pneumonia
• Lung Injury
• Pneumonia
• Wounds and Injuries

Intervention

Drug:
• CERC-002
Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
• Placebo
Administered once subcutaneously

Locations

Country	Name	City	State
United States	AnMed Health Medical Center	Anderson	South Carolina
United States	Lowcountry Infectious Diseases, P.A.	Charleston	South Carolina
United States	Carolina Institute for Clinical Research, LLC	Fayetteville	North Carolina
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Parkview Research Center	Fort Wayne	Indiana
United States	BRCR Global Texas	McAllen	Texas
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	LSUHSC - Shreveport	Shreveport	Louisiana
United States	Triple O Research Institute, P.A.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aevi Genomic Medicine, LLC, a Cerecor company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Perlin DS, Neil GA, Anderson C, Zafir-Lavie I, Raines S, Ware CF, Wilkins HJ. Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. J Clin Invest. 2022 Feb 1;132(3). pii: e15317 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to Day 28
Secondary	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	Baseline to Day 28