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

University at Buffalo (UB)

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Melatonin; Other: Placebo (Methylcellulose) capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04474483

UBMELCOVID19

Details and patient eligibility

About

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.

Full description

This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in outpatient adult patients suspected to be afflicted with COVID-19. Participants will be enrolled as outpatients within 72 hrs of onset of COVID-19 symptoms. The study will evaluate the safety of the intervention 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), and/or discontinuation or temporary suspension of the investigational medication (for any reason). Additionally, the study will aim to evaluate the clinical efficacy of melatonin as compared to placebo as assessed by hospitalization, COVID-19 related symptoms and mortality. The ultimate goal is to determine in an adequately powered study if the anti-inflammatory and antioxidant actions of Melatonin can reduce the severity and prevent progression of COVID-19 when started in mild disease.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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:

Other: Placebo (Methylcellulose) capsule

Melatonin

Experimental group

Description:

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.

Treatment:

Drug: Melatonin