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NCT04412057 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target

NCT04412057 is a Phase 2 study that has completed, run by Aevi Genomic Medicine, LLC, a Cerecor company. The registered enrollment target is 88 participants.

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The verdict

NCT04412057, a Phase 2 study, has completed, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG CERC-002

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2020-07-17
Est. Completion 2021-01-19
Phase Phase 2

What the Registry Record Tells You About NCT04412057

The ClinicalTrials.gov registry entry for NCT04412057 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aevi Genomic Medicine, LLC, a Cerecor company, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04412057 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04412057 about?

NCT04412057 is a clinical study titled "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 recept...

What is the current status of trial NCT04412057?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2020-07-17. Estimated completion is 2021-01-19.

What interventions are being tested in trial NCT04412057?

The interventions under investigation include: Placebo (DRUG), CERC-002 (DRUG).

Who is sponsoring clinical trial NCT04412057?

This trial is sponsored by Aevi Genomic Medicine, LLC, a Cerecor company, which has 10 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.