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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412057
Recruitment Status : Completed
First Posted : June 2, 2020
Results First Posted : March 4, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Avalo Therapeutics, Inc. ( 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.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Acute Lung Injury ARDS Drug: CERC-002 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 17, 2020
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : January 19, 2021


Arm Intervention/treatment
Experimental: CERC-002 Drug: CERC-002
Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
Other Name: AEVI-002 and MDGN-002

Placebo Comparator: Placebo Drug: Placebo
Administered once subcutaneously




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412057


Locations
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United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
United States, Florida
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33407
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
United States, Louisiana
MedPharmics, LLC
Metairie, Louisiana, United States, 70006
LSUHSC - Shreveport
Shreveport, Louisiana, United States, 71103
United States, North Carolina
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States, 28304
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, United States, 29414
United States, Texas
BRCR Global Texas
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Aevi Genomic Medicine, LLC, a Cerecor company
Investigators
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Study Director: Scott White, MD Aevi Genomic Medicine, LLC, a Cerecor company
  Study Documents (Full-Text)

Documents provided by Avalo Therapeutics, Inc. ( Aevi Genomic Medicine, LLC, a Cerecor company ):
Study Protocol  [PDF] August 12, 2020
Statistical Analysis Plan  [PDF] December 15, 2020

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aevi Genomic Medicine, LLC, a Cerecor company
ClinicalTrials.gov Identifier: NCT04412057    
Other Study ID Numbers: CERC-002-CVID-201
First Posted: June 2, 2020    Key Record Dates
Results First Posted: March 4, 2022
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Lung Injury
Acute Lung Injury
Wounds and Injuries
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries