COVID-19 Clinical Trial
Official title:
A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection
Verified date | July 2022 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety, Efficacy and Dose-ranging.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo | National Center for Advancing Translational Science (NCATS) |
United States,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative Incidence of Treatment-Emergent Adverse Events | Evaluate the incidence of serious adverse effects and discontinuation secondary to toxicity through 42 days of follow-up as compared to the control arm as assessed by: Cumulative incidence of serious adverse events (SAEs), Cumulative incidence of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason). | 42 days | |
Secondary | Incidence of COVID-19 related hospitalization | Incidence of COVID-19 related hospitalization at 42 days | 42 days | |
Secondary | COVID-19 related symptoms | COVID-19 related symptoms as self-reported and on interview. | 42 days | |
Secondary | Rate of resolution of COVID-19 related symptoms | Change from baseline (day 1) as assessed to days 3, 7, 14, 28 and 42 | up to 42 days | |
Secondary | Mortality | 42-day mortality | 42 days |
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