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Completed

NCT Number: NCT04412057

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

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.

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Key information

Conditions

COVID-19 Pneumonia ARDS Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hoag Memorial Hospital, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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.

Treatment and study plan

CERC-002

Drug

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

Other names: AEVI-002 and MDGN-002

Placebo

Drug

Administered once subcutaneously

Primary outcomes

  1. Number of Subjects Alive and Free of Respiratory Failure

    Time frame: 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 outcomes

  1. Number of Subjects Who Are Alive at Day 28

    Time frame: Baseline to Day 28

    1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit

Sponsors and collaborators

Lead sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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