Melatonin for COVID-19

University at Buffalo, Buffalo, NY
Targeting 2 different conditionsMelatonin +1 morePhase 2Waitlist AvailableLed by Margarita L Dubocovich, Ph.D.Research Sponsored by State University of New York at Buffalo

Study Summary

This trial will test if melatonin is safe and effective in treating adults suspected to have COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below


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
Cumulative Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
COVID-19 related symptoms
+1 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Daytime drowsiness
Blurred vision
Study treatment Arm

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
232 Previous Clinical Trials
48,023 Total Patients Enrolled
2 Trials studying COVID-19
53 Patients Enrolled for COVID-19
Margarita L Dubocovich, Ph.D.Principal Investigator
University at Buffalo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative research endeavor?

"Since 2007, Melatonin has been the subject of 24 live studies spread across 9 countries and 12 cities. This journey began in 2007 with a 20 participant study backed by Eli Lilly & Co., culminating in formal drug approval for this medication."

Answered by AI

What potential pitfalls are associated with Melatonin supplementation?

"Pre-existing data affirms the safety of Melatonin, thus it recieved a score of 2 on our scale. As this is only in Phase 2, there is no evidence yet to support efficacy."

Answered by AI

Is enrollment for this experiment still available?

"Correct. According to the clinicaltrials.gov website, this investigation is currently recruiting participants and was initially posted on November 6th 2020 with recent changes made as of March 10th 2022. The overall goal is to recruit 30 patients from one particular site."

Answered by AI

Are there any other empirical studies which have examined the efficacy of Melatonin?

"There are currently 24 medical trials actively researching the effects of Melatonin, with 4 trials in their concluding Phase 3. Although most studies take place around Houston, Texas, investigations into this medication span across 25 different sites."

Answered by AI

How many individuals have been selected for participation in this experiment?

"Indeed, the clinicaltrials.gov portal confirms that this medical trial is currently recruiting patients. It was initially posted on November 6th 2020 and has been recently updated on March 10th 2022. A total of 30 participants are needed at one research centre for successful completion of this study."

Answered by AI
Recent research and studies
~2 spots leftby Sep 2024