Status:

TERMINATED

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

Lead Sponsor:

State University of New York at Buffalo

Conditions:

COVID-19

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Detailed 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....

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 6 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 22 2022

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04474483

Start Date

November 6 2020

End Date

July 22 2022

Last Update

February 7 2024

Active Locations (1)

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University at Buffalo

Buffalo, New York, United States, 14203