Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 (COVID-19)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Melatonin, COVID-19, SARS-CoV-2
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
Sites / Locations
- University at Buffalo
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control
Melatonin
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.
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.