Status:
COMPLETED
Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
Lead Sponsor:
Aevi Genomic Medicine, LLC, a Cerecor company
Conditions:
COVID-19 Pneumonia
Acute Lung Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Inducibl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04412057
Start Date
July 17 2020
End Date
January 19 2021
Last Update
March 24 2022
Active Locations (11)
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1
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
2
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
3
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33407
4
Parkview Research Center
Fort Wayne, Indiana, United States, 46845