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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: Clinical Trial Phase 2 study, sponsored by Inovio Pharmaceuticals.
NCT04642638 is a Phase 2 study that was terminated before completion, run by Inovio Pharmaceuticals. The registered enrollment target is 1,307 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (883% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10\^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.
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 |
Why NCT04642638 stopped before completion
NCT04642638 is an interventional study that assigns participants to a tested intervention. Its 1,307 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (883% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04642638 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04642638's enrollment target sits among peer trials
1,307 13th of 2000 higher than 1,988 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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