Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety, Efficacy and Dose-ranging.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Treatments: Melatonin

Criteria

Inclusion Criteria:

1. Male or non-pregnant female adult ≥18 years of age at time of enrollment.

2. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.

3. Positive testing for COVID-19 infection by standard RT-PCR assay or equivalent test.

4. Meets criteria for mild or moderate COVID-19 disease

5. Subject provides written informed consent prior to initiation of any study procedures.

6. Understands and agrees to comply with planned study procedures.

7. Agrees to the collection and storage of saliva samples per protocol.

8. 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:

1. Severe (eGFR<30 ml/min) and moderate (eGFR 30-60 ml/min) chronic kidney disease or requiring dialysis

2. 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)

3. Pregnancy or breast feeding.

4. History of a seizure disorder.

5. Patient is taking Fluvoxamine, Capmatinib, Ciprofloxacin (Systemic), Deferasirox, Givosiran, Methoxsalen (Systemic), Mexiletine, Rucaparib, Stiripentol, Thiabendazole, Vemurafenib, Methoxsalen, Sodium oxybate or Echinacea.

6. Allergy to the study medication

7. Currently taking melatonin

8. Currently taking high dose (>500 mg/day) Vitamin C.

9. Meets criteria for Severe or Critical COVID-19