Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Melatonin, COVID-19, outpatient, 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.
- Positive testing for COVID-19 infection by standard RT-PCR assay or equivalent test.
- Meets criteria for mild or moderate COVID-19 disease
- 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.
- Subject can provide an emergency contact who the study team can contact in case the subject is not reachable on any of the study visits.
Exclusion Criteria:
- Severe (eGFR<30 ml/min) and moderate (eGFR 30-60 ml/min) chronic kidney disease or requiring dialysis
- Severe hepatic insufficiency defined as one or more of the following: Cirrhosis diagnosis, Serum ALT > 3x ULN or Alkaline phosphatase >3x ULN or bilirubin >2x ULN in the absence of Gilbert's or hemolysis, Uncontrolled acute or chronic liver disease (e.g. acute hepatitis A, unstable autoimmune hepatitis)
- Pregnancy or breast feeding.
- History of a seizure disorder.
- Patient is taking Fluvoxamine, Capmatinib, Ciprofloxacin (Systemic), Deferasirox, Givosiran, Methoxsalen (Systemic), Mexiletine, Rucaparib, Stiripentol, Thiabendazole, Vemurafenib, Methoxsalen, Sodium oxybate or Echinacea.
- Allergy to the study medication
- Currently taking melatonin
- Currently taking high dose (>500 mg/day) Vitamin C.
- Meets criteria for Severe or Critical COVID-19
Sites / Locations
- University at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Melatonin 3 mg
Melatonin 30 mg
Placebo capsules will be prepared using hypromellose capsules, filled using microcrystalline cellulose. This is the same excipient used in the preparation of the interventional drug. Placebo will be administered orally three times a day for 14 days in the same regimen used for the intervention.
Melatonin capsules will be prepared using hypromellose capsules containing 3 mg of the active component and identical excipient (Microcrystalline Cellulose) used in the placebo preparation. Melatonin will be administered orally three times a day for 14 days.
Melatonin capsules will be prepared using hypromellose capsules containing 30 mg of the active component and identical excipient (Microcrystalline Cellulose) used in the placebo preparation. Melatonin will be administered orally three times a day for 14 days.