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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: Completed Phase 2 study, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG CERC-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2021-01-19 |
| Phase | Phase 2 |
What the finished NCT04412057 record still lists
NCT04412057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04412057 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04412057's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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