Clinical trial NCT04412057: Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Pneumonia
Acute Lung Injury
ARDS
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Alive and Free of Respiratory Failure
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Number of Subjects Who Are Alive at Day 28
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC - Shreveport
state: Louisiana
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research, LLC
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Lowcountry Infectious Diseases, P.A.
state: South Carolina
city: McAllen
country: United States
facility: BRCR Global Texas
state: Texas
Study officials:
affiliation: Aevi Genomic Medicine, LLC, a Cerecor company
name: Scott White, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.