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Melatonin for COVID-19 (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 will test if melatonin is safe and effective in treating adults suspected to have COVID-19.

Eligible Conditions
  • COVID-19
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Treatment-Emergent Adverse Events
Secondary outcome measures
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
249 Previous Clinical Trials
49,528 Total Patients Enrolled
2 Trials studying COVID-19
53 Patients Enrolled for COVID-19
Margarita L Dubocovich, Ph.D.Principal InvestigatorUniversity at Buffalo
~2 spots leftby Jul 2025