Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 (COVID-19)
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ClinicalTrials.gov Identifier: NCT04474483 |
Recruitment Status :
Recruiting
First Posted : July 16, 2020
Last Update Posted : March 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Melatonin Other: Placebo (Methylcellulose) capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | placebo-controlled randomized double-blind pilot trial |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection |
Actual Study Start Date : | November 6, 2020 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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Placebo Comparator: Control
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.
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Other: Placebo (Methylcellulose) capsule
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.
Other Name: Methylcellulose |
Experimental: Melatonin
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.
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Drug: Melatonin
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.
Other Name: 5-methoxy-N-acetyl tryptamine |
- Cumulative Incidence of Treatment-Emergent Adverse Events [ Time Frame: 28 days ]Evaluate the incidence 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 incidence of serious adverse events (SAEs), Cumulative incidence of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason).
- Hospitalization [ Time Frame: 28 days ]Incidence of COVID-19 related hospitalization at 28 days
- COVID-19 related symptoms [ Time Frame: 28 days ]COVID-19 related symptoms (Fever, chills, cough, nasal symptoms, body aches/muscle aches, headache, loss of smell, loss of taste, nausea, vomiting, diarrhea, fatigue, dizziness) that are self-reported and on interview.
- Rate of resolution of COVID-19 related symptoms [ Time Frame: 28 days ]Change from baseline (day 1) as assessed to days 3, 7, 14, and 28
- Mortality [ Time Frame: 28 days ]28-day mortality

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Subject provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection and storage of saliva samples per protocol.
Exclusion Criteria:
- Severe chronic liver disease
- Severe chronic kidney disease or requiring dialysis
- Pregnancy or breast feeding.
- Allergy to the study medication
- Currently taking melatonin
- Currently taking high dose (>500 mg/day) Vitamin C

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474483
Contact: Margarita L Dubocovich, Ph.D. | (716) 829-3048 | mdubo@buffalo.edu | |
Contact: Sanjay Sethi, MD | (716) 888-4864 | ssethi@buffalo.edu |
United States, New York | |
University at Buffalo | Recruiting |
Buffalo, New York, United States, 14203 | |
Contact: Margarita Dubocovich, Ph.D. 716-829-3048 mdubo@buffalo.edu | |
Contact: Sanjay Sethi, MD (716) 888-4864 ssethi@buffalo.edu |
Principal Investigator: | Margarita L Dubocovich, Ph.D. | University at Buffalo |
Publications:
Responsible Party: | Margarita L. Dubocovich, PhD, SUNY Distinguished Professor Dept of Pharmacology and Toxicology, State University of New York at Buffalo |
ClinicalTrials.gov Identifier: | NCT04474483 |
Other Study ID Numbers: |
UBMELCOVID19 |
First Posted: | July 16, 2020 Key Record Dates |
Last Update Posted: | March 14, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melatonin COVID-19 SARS-CoV-2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |