Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19

NCT04474483 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: UBMELCOVID19
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.

Conditions

COVID-19

Keywords

Melatonin; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-Emergent Adverse Events

  Evaluate the number 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 number of serious adverse events (SAEs), Cumulative number of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason).

  28 days

Secondary Outcomes (4)

• Hospitalization

  28 days

• COVID-19 Related Symptoms

  28 days

• Rate of Resolution of COVID-19 Related Symptoms

  28 days

• Mortality

  28 days

Study Arms (2)

Control

PLACEBO COMPARATOR

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: Placebo (Methylcellulose) capsule

Melatonin

EXPERIMENTAL

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.

Drug: Melatonin

Interventions

Melatonin DRUG

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.

Also known as: 5-methoxy-N-acetyl tryptamine

Melatonin

Placebo (Methylcellulose) capsule OTHER

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.

Also known as: Methylcellulose

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (18)

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  PMID: 31210428 BACKGROUND

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  PMID: 26692007 BACKGROUND

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  PMID: 30328031 BACKGROUND

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• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

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• Law HK, Cheung CY, Ng HY, Sia SF, Chan YO, Luk W, Nicholls JM, Peiris JS, Lau YL. Chemokine up-regulation in SARS-coronavirus-infected, monocyte-derived human dendritic cells. Blood. 2005 Oct 1;106(7):2366-74. doi: 10.1182/blood-2004-10-4166. Epub 2005 Apr 28.

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• Pedreira PR, Garcia-Prieto E, Parra D, Astudillo A, Diaz E, Taboada F, Albaiceta GM. Effects of melatonin in an experimental model of ventilator-induced lung injury. Am J Physiol Lung Cell Mol Physiol. 2008 Nov;295(5):L820-7. doi: 10.1152/ajplung.90211.2008. Epub 2008 Sep 19.

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• Peng Z, Zhang W, Qiao J, He B. Melatonin attenuates airway inflammation via SIRT1 dependent inhibition of NLRP3 inflammasome and IL-1beta in rats with COPD. Int Immunopharmacol. 2018 Sep;62:23-28. doi: 10.1016/j.intimp.2018.06.033. Epub 2018 Jun 30.

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MeSH Terms

Conditions

COVID-19

Interventions

Melatonin; Methylcellulose; Capsules

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cellulose; Glucans; Polysaccharides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Sanjay Sethi MD
• Organization: University at Buffalo, SUNY

ssethi@buffalo.edu

7168884864

Study Officials

• Margarita L Dubocovich, Ph.D.

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor Dept of Pharmacology and Toxicology

Model Details: placebo-controlled randomized double-blind pilot trial

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: July 16, 2020
• Study Start: November 6, 2020
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Locations

US (1)