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NCT04474483 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
A Phase 2 study, sponsored by State University of New York at Buffalo.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04474483: Clinical Trial Phase 2 study, sponsored by State University of New York at Buffalo.
NCT04474483 is a Phase 2 study that was terminated before completion, run by State University of New York at Buffalo. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04474483, a Phase 2 study, was terminated before completion, sponsored by State University of New York at Buffalo.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.
Primary Outcome
Evaluate the number of serious adverse effects and discontinuation secondary to toxicity through 28 days of follow-up as compared to the control arm as assessed by: Cumulative number of serious adverse events (SAEs), Cumulative number of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason).
Interventions
- DRUG Melatonin
- OTHER Placebo (Methylcellulose) capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-11-06 |
| Est. Completion | 2022-07-22 |
| Phase | Phase 2 |
Why NCT04474483 stopped before completion
NCT04474483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.
NCT04474483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04474483 about?
NCT04474483 is a clinical study titled "Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19". This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.
What is the current status of trial NCT04474483?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-11-06. Estimated completion is 2022-07-22.
What interventions are being tested in trial NCT04474483?
The interventions under investigation include: Melatonin (DRUG), Placebo (Methylcellulose) capsule (OTHER).
Who is sponsoring clinical trial NCT04474483?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04474483's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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