Phase 2
N=83
Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
COVID-19 Pneumonia · Acute Lung Injury · ARDS
Bottom Line
View on ClinicalTrials.gov: NCT04412057 ↗Enrolled (actual)
83
Serious AEs
24.4%
Results posted
Mar 2022
Primary outcome: Primary: Number of Subjects Alive and Free of Respiratory Failure — 26; 20 Participants — p=0.0440
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CERC-002 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Alive and Free of Respiratory Failure |
26; 20 | 0.0440 sig |
| SECONDARY Number of Subjects Who Are Alive at Day 28 |
36; 36 | 0.1762 |
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
- Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.
- Subject is ≥18 years of age at the time of informed consent and assent (as applicable).
- 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.
- Subject has a diagnosis of COVID-19 infection through an approved testing method.
- 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.
- Subject's oxygen saturation at rest in ambient air <93%
Exclusion Criteria
- Subject is intubated.
- Subject is currently taking immunomodulators or anti-rejection drugs.
- Subject has been administered an immunomodulating biologic drug within 60 days of baseline.
- 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.
- Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.
Data sourced from ClinicalTrials.gov (NCT04412057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.