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Melatonin for COVID-19
Phase 2
Waitlist Available
Led By Margarita L Dubocovich, PhD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
Study Summary
This study is evaluating whether melatonin may help reduce the severity of symptoms for individuals with a certain type of infection.
Eligible Conditions
- COVID-19
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
COVID-19 related symptoms
Incidence of COVID-19 related hospitalization
Mortality
+1 moreSide effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Melatonin 30 mgExperimental Treatment1 Intervention
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.
Group II: Melatonin 3 mgExperimental Treatment1 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.
Group III: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Find a Location
Who is running the clinical trial?
State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,508 Total Patients Enrolled
2 Trials studying COVID-19
61 Patients Enrolled for COVID-19
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,749 Total Patients Enrolled
20 Trials studying COVID-19
267,447 Patients Enrolled for COVID-19
Margarita L Dubocovich, PhDPrincipal InvestigatorUniversity at Buffalo
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