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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1
University at Buffalo
Buffalo, New York, United States, 14203