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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERC-002 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERC-002 | Drug | Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Alive and Free of Respiratory Failure | Respiratory failure defined based on resource utilization requiring at least one of the following:
| Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott White, MD | Aevi Genomic Medicine, LLC, a Cerecor company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital | Newport Beach | California | 92663 | United States | ||
| Midway Immunology and Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34871182 | Result | 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. | |
| 32817460 | Derived | 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. |
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Of the 88 enrolled patients, 83 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CERC-002 | CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. |
| FG001 | Placebo | Placebo: Administered once subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2020 | Feb 16, 2022 |
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Double-blind (Participant, Investigator)
| Placebo | Drug | Administered once subcutaneously |
|
| Ft. Pierce |
| Florida |
| 34982 |
| United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| LSUHSC - Shreveport | Shreveport | Louisiana | 71103 | United States |
| Carolina Institute for Clinical Research, LLC | Fayetteville | North Carolina | 28304 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| AnMed Health Medical Center | Anderson | South Carolina | 29621 | United States |
| Lowcountry Infectious Diseases, P.A. | Charleston | South Carolina | 29414 | United States |
| BRCR Global Texas | McAllen | Texas | 78503 | United States |
| Randomized Analysis Set |
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| Safety Analysis Set |
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| Full Analysis Set |
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| Primary Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Randomized Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | CERC-002 | CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. |
| BG001 | Placebo | Placebo: Administered once subcutaneously |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Corticosteroid Use | Count of Participants | Participants |
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| Remdesivir Use | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Alive and Free of Respiratory Failure | Respiratory failure defined based on resource utilization requiring at least one of the following:
| The number of subjects alive and free of respiratory failure up to Day 28/Early Termination (ET). The study was designed with broad eligibility criteria allowing patients who received high-flow oxygen or positive-pressure oxygen prior to dosing to be enrolled. As overlap was expected patients who were in respiratory failure before dosing or who required elevation in their ventilation support were excluded from the primary analysis (N=20, 9 CERC-002 patients and 11 placebo patients). | Posted | Count of Participants | Participants | Baseline to Day 28 |
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| 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 | The Full Analysis Set included all subjects who received at least one dose of investigational product and had a baseline and at least one post-baseline efficacy assessment. There was 1 subject who did not have a survival status at Day 28 so is therefore excluded from the secondary analysis of the number of subjects who were alive at Day 28. | Posted | Count of Participants | Participants | Baseline to Day 28 |
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All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CERC-002 | CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. | 4 | 40 | 8 | 40 | 10 | 40 |
| EG001 | Placebo | Placebo: Administered once subcutaneously | 9 | 42 | 12 | 42 | 6 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Ventricular Fibrillation | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Adverse event | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hepatic Enzyme Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott White, MD | Avalo Therapeutics, Inc. | 484-763-3080 | swhite@avalotx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2020 | Feb 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| No |
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