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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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant female adult ≥18 years of age at time of enrollment.

Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up28 days

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

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

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%

Dizziness

11%

Nausea

11%

Weakness

11%

Blurred vision

100%

80%

60%

40%

20%

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

FDA approved

0 / 5Eligibility criteria met

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

Acta Pharmacologica SinicaJournal

Melatonin Reduces Acute Lung Inflammation, Edema, and Hemorrhage in Heatstroke Rats

Wu, Wen-shiann, Ming-ting Chou, Chien-ming Chao, Chen-kuei Chang, Mao-tsun Lin, and Ching-ping Chang. 2012. “Melatonin Reduces Acute Lung Inflammation, Edema, and Hemorrhage in Heatstroke Rats”. Acta Pharmacologica Sinica. Springer Science and Business Media LLC. doi:10.1038/aps.2012.29.

International Journal of Molecular SciencesJournal

Melatonin Protects Against Lung Fibrosis by Regulating the Hippo/yap Pathway

Zhao, Xiaoguang, Jian Sun, Wei Su, Huitong Shan, Bowen Zhang, Yining Wang, Azaliia Shabanova, Hongli Shan, and Haihai Liang. 2018. “Melatonin Protects Against Lung Fibrosis by Regulating the Hippo/yap Pathway”. International Journal of Molecular Sciences. MDPI AG. doi:10.3390/ijms19041118.

Clinical Drug InvestigationJournal

The Safety of Melatonin in Humans

Andersen, Lars Peter Holst, Ismail Gögenur, Jacob Rosenberg, and Russel J. Reiter. 2015. “The Safety of Melatonin in Humans”. Clinical Drug Investigation. Springer Science and Business Media LLC. doi:10.1007/s40261-015-0368-5.

InflammopharmacologyJournal