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NCT04642638 · ClinicalTrials.gov registry record · Phase 2
Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
A Phase 2 study, sponsored by Inovio Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1,307
- Enrollment target
NCT04642638 is a Phase 2 study that was terminated before completion, run by Inovio Pharmaceuticals. The registered enrollment target is 1,307 participants.
The verdict
NCT04642638, a Phase 2 study, was terminated before completion, sponsored by Inovio Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1,307 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DEVICE CELLECTRA® 2000
- DRUG INO-4800
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,307 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2022-09-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04642638
The ClinicalTrials.gov registry entry for NCT04642638 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1,307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inovio Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04642638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04642638 about?
NCT04642638 is a clinical study titled "Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure". 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 participa...
What is the current status of trial NCT04642638?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1,307 participants. The study started on 2020-11-30. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT04642638?
The interventions under investigation include: Placebo (DRUG), CELLECTRA® 2000 (DEVICE), INO-4800 (DRUG).
Who is sponsoring clinical trial NCT04642638?
This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
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