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NCT04590586 · ClinicalTrials.gov registry record · Phase 3
Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT04590586: Completed Phase 3 study, sponsored by Amgen.
NCT04590586 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 515 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04590586, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation.
Primary Outcome
Confirmed clinical recovery means the participant is fit for discharge from hospital, defined by achieving a score of 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), or 8 (not hospitalized, no limitations on activities) on the clinical severity status 8-point ordinal scale, without being re-hospitalized prior to Day 29. The Kaplan-Meier estimate of the time to confirmed cli
Interventions
- DRUG Apremilast
- DRUG Standard of care
- DRUG Lanadelumab
- DRUG Apremilast placebo
- DRUG Lanadelumab placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2021-08-03 |
| Phase | Phase 3 |
What the finished NCT04590586 record still lists
NCT04590586 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which Apremilast is the first listed.
NCT04590586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04590586 about?
NCT04590586 is a clinical study titled "Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients". The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depend...
What is the current status of trial NCT04590586?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2020-11-24. Estimated completion is 2021-08-03.
What interventions are being tested in trial NCT04590586?
The interventions under investigation include: Apremilast (DRUG), Standard of care (DRUG), Lanadelumab (DRUG), Apremilast placebo (DRUG), Lanadelumab placebo (DRUG).
Who is sponsoring clinical trial NCT04590586?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04590586's enrollment target sits among peer trials
515 724th of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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