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

NCT04412057 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CERC-002-CVID-201
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 11

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.

Conditions

COVID-19 Pneumonia; Acute Lung Injury; ARDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Subjects Who Are Alive at Day 28

  Baseline to Day 28

Study Arms (2)

CERC-002

EXPERIMENTAL

Drug: CERC-002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CERC-002 DRUG

Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.

Also known as: AEVI-002 and MDGN-002

CERC-002

Placebo DRUG

Administered once subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aevi Genomic Medicine, LLC, a Cerecor company: lead

Study Sites (11)

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33407, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

LSUHSC - Shreveport

Shreveport, Louisiana, 71103, United States

Location

Carolina Institute for Clinical Research, LLC

Fayetteville, North Carolina, 28304, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

AnMed Health Medical Center

Anderson, South Carolina, 29621, United States

Location

Lowcountry Infectious Diseases, P.A.

Charleston, South Carolina, 29414, United States

Location

BRCR Global Texas

McAllen, Texas, 78503, United States

Location

Related Publications (2)

• 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):e153173. doi: 10.1172/JCI153173.

  PMID: 34871182 RESULT

• Perlin DS, Zafir-Lavie I, Roadcap L, Raines S, Ware CF, Neil GA. Levels of the TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19 Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug 12;5(4):e00699-20. doi: 10.1128/mSphere.00699-20.

  PMID: 32817460 DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was designed to use broad eligibility criteria including patients who received high-flow oxygen or positive-pressure oxygen prior to randomization. Some overlap was expected between the entry criteria and the primary endpoint. Therefore patients who were in respiratory failure before dosing or who required an elevation in their ventilation support were excluded (N=20). In addition, to increase statistical power, a 1-sided χ2 test was used.

Results Point of Contact

• Title: Scott White, MD
• Organization: Avalo Therapeutics, Inc.

swhite@avalotx.com

484-763-3080

Study Officials

• Scott White, MD

  Aevi Genomic Medicine, LLC, a Cerecor company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: July 17, 2020
• Primary Completion: December 14, 2020
• Study Completion: January 19, 2021
• Last Updated: March 24, 2022
• Results First Posted: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)