Seeking people with COVID-19 Symptoms
Protocol: STUDY00004561
Full Title
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID infection.
Description
This study enrolls people with COVID-19 symptoms. These symptoms include fever, chills, cough, nasal symptoms, body aches/muscle aches, headache, loss of smell, loss of taste, nausea, vomiting, diarrhea, fatigue, dizziness. The purpose of the study is to learn if a supplement will reduce inflammation and improve immune response in people with COVID-19.

People enrolled in this study will be randomly assigned (like the flip of a coin) to take either the study supplement or a placebo. The placebo is a supplement with no active ingredients. You and the study team will not know if you are taking the study supplement or the placebo. You will take the study supplement or placebo three times a day for 14 days. Temperature, saliva samples and COVID-19 symptoms will be reported to the study team over 28-days. The study takes place entirely in your home- you will be mailed the study supplement or placebo and you will complete phone calls with the study team.

Technical 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.
Subjects with symptoms of COVID-19 will be identified through primary care. Subjects will take melatonin (10 mg) or placebo three times a day for 14 days.
The following will be done:
1. 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).
Discontinuation or temporary suspension of the investigational medication (for any reason).
2. Evaluate the clinical efficacy of melatonin as compared to placebo as assessed by:
o Clinical Severity
o Hospitalization
- Incidence of COVID related hospitalization at 28 days.
- COVID related symptoms
- The speed of resolution of COVID related symptoms
- Change from baseline (Day 1) to days 3, 7, 14, and 28.
o Mortality
- 28-day mortality.


Keyword: COVID-19
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Age Group: Adults
Principal Investigator: MARGARITA DUBOCOVICH
Contact(s)
KIMBERLY BRUNTON
kbrunton@buffalo.edu
+1 716-888-4840
Want to Learn More?
Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.