Clinical trial

A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection

Name

UBMELCOVID19

Description

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.

Trial arms

Trial start

2020-11-06

Estimated PCD

2022-07-22

Trial end

2022-07-22

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Melatonin

Other names:

5-methoxy-N-acetyl tryptamine

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.

Arms:

Control

Other names:

Methylcellulose

Size

Primary endpoint

Number of Treatment-Emergent Adverse Events

28 days

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled randomized double-blind pilot trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

Updated at

2024-02-07

1 organization

1 product

1 indication

Organization

State University of New York at Buffalo

Product

Melatonin

Indication

COVID-19