Status:
WITHDRAWN
Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety, Efficacy and Dose-ranging.
Detailed Description
Studies have shown in the blood of patients with COVID-19 there was a marked increase in the cytokines and chemokines interleukin 1β (IL-1β), interferon-γ (IFN-γ), interferon-inducible protein 10 (IP-...
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.
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04784754
Start Date
April 1 2021
End Date
December 31 2022
Last Update
July 22 2022
Active Locations (1)
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1
University at Buffalo
Buffalo, New York, United States, 14203