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Melatonin for Coronavirus (COVID-19 Trial)

Phase 2
Waitlist Available
Led By Margarita L Dubocovich, Ph.D.
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

This trial is testing melatonin, a common sleep aid, to see if it can help adults with early symptoms of COVID-19. The goal is to find out if melatonin can reduce inflammation and protect cells, thereby lessening the severity of the disease. The study aims to evaluate the safety and effectiveness of melatonin. Melatonin is registered to treat circadian rhythm sleep-wake disorders and insomnia in patients aged 55 years and over.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Treatment-Emergent Adverse Events
Secondary study objectives
COVID-19 Related Symptoms
Hospitalization
Mortality
+1 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.
Group II: ControlPlacebo Group1 Intervention
Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
264 Previous Clinical Trials
52,092 Total Patients Enrolled
Margarita L Dubocovich, Ph.D.Principal InvestigatorUniversity at Buffalo
~2 spots leftby Sep 2025
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