Clinical trial NCT04474483: Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Official title: A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: Melatonin
COVID-19
SARS-CoV-2
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled randomized double-blind pilot trial
Primary purpose: TREATMENT

Brief summary: This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.

Detailed description: This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in outpatient adult patients suspected to be afflicted with COVID-19. Participants will be enrolled as outpatients within 72 hrs of onset of COVID-19 symptoms. The study will evaluate the safety of the intervention through 28 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), and/or discontinuation or temporary suspension of the investigational medication (for any reason). Additionally, the study will aim to evaluate the clinical efficacy of melatonin as compared to placebo as assessed by hospitalization, COVID-19 related symptoms and mortality. The ultimate goal is to determine in an adequately powered study if the anti-inflammatory and antioxidant actions of Melatonin can reduce the severity and prevent progression of COVID-19 when started in mild disease.

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.
* 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.

Exclusion Criteria:

* Severe chronic liver disease
* Severe chronic kidney disease or requiring dialysis
* Pregnancy or breast feeding.
* Allergy to the study medication
* Currently taking melatonin
* Currently taking high dose (\>500 mg/day) Vitamin C

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Hospitalization
timeFrame: 28 days
measure: COVID-19 Related Symptoms
timeFrame: 28 days
measure: Rate of Resolution of COVID-19 Related Symptoms
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Margarita L Dubocovich, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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