Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID-19 Disease
In brief
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Key facts
- Study ID
- NCT04642638
- Run by
- Inovio Pharmaceuticals
- People needed
- 1307
- Starts
- 2020-11-30
- Expected to finish
- 2022-09-13
- Last updated by the study team
- 2023-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Synexus Clinical Research US, Inc - Phoenix Southeast — Chandler, Arizona, United States
- Central Phoenix Synexus Clinical Research — Phoenix, Arizona, United States
- AMR Tempe — Tempe, Arizona, United States
- Optimal Research, LLC — San Diego, California, United States
- AMR South Florida — Coral Gables, Florida, United States
- Clinical Research Trials of Florida, Inc — Tampa, Florida, United States
- AMR Lexington — Lexington, Kentucky, United States
- Walter Reed Army Institute of Research — Silver Spring, Maryland, United States
- Ascension St. John Hospital — Detroit, Michigan, United States
- AMR Kansas City — Kansas City, Missouri, United States
- AMR, Clinical Research Consortium- Las Vegas — Las Vegas, Nevada, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Tekton Research — San Antonio, Texas, United States
- DM Clinical Research — Tomball, Texas, United States
- Advanced Clinical Research — West Jordan, Utah, United States
- Centro de Investigacion Medico Asistencial S.A.S — Barranquilla, Atlántico, Colombia
- Clinica de la Costa LTDA — Barranquilla, Atlántico, Colombia
- Corazon IPS S.A.S — Barranquilla, Atlántico, Colombia
- Ips Centro Cientifico Asistencial Sas — Barranquilla, Atlántico, Colombia
- Centro de Investigaciones Clinicas IPS Cardiomet Pereira — Pereira, Risaralda Department, Colombia
- BRCR Global Mexico — Guadalajara, Jalisco, Mexico
- Eukarya Pharmasite SC — Monterrey, Nuevo León, Mexico
- Unidad de Medicina Especializada SMA — San Juan del Río, Querétaro, Mexico
- Clinstile, SA de CV — Mexico City, Mexico
Full record on ClinicalTrials.gov
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