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NCT04661839 · ClinicalTrials.gov registry record · Phase 1
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04661839: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT04661839 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04661839, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
Primary Outcome
Number of subjects with AEs and severity of AEs up to 3 days post-dosing.
Interventions
- OTHER Placebo (saline)
- BIOLOGICAL COVID-HIGIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-12-24 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 1 |
What the finished NCT04661839 record still lists
NCT04661839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (saline) is the first listed.
NCT04661839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04661839 about?
NCT04661839 is a clinical study titled "A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults". This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with...
What is the current status of trial NCT04661839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-12-24. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT04661839?
The interventions under investigation include: Placebo (saline) (OTHER), COVID-HIGIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04661839?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04661839's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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