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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Treatments: Melatonin

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