CTSA pilot: A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID infection
This study enrolls adults with COVID-19 symptoms. The purpose of this study is to learn if an exploratory drug will lessen hospitalization and symptoms in people with COVID-19.
If you have not had a positive COVID-19 test but have symptoms, you may be eligible for a free COVID-19 rapid test in this study. You will be in this study for about 6 weeks. During that time, you will take the study medication or a placebo 3x/day for 2 weeks. A placebo looks like the study drug but has no active ingredients, and you have a 50/50 chance of getting the placebo or the study medication (like flipping a coin). Your first visit will be in person in your own home, and the rest of the study will be done via phone or mail.
The primary objective is to evaluate the safety of the intervention 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).
The secondary objective is to evaluate the clinical efficacy of melatonin as
compared to placebo as assessed by:
Incidence of COVID related hospitalization and all-cause hospitalization at 42 days.
The speed of resolution of COVID related symptoms (defined as time to complete resolution of
Change in the WHO Clinical Progression Scale (0-10)
Mortality at 42 days.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Adults ages 18+.
Currently have COVID-19 symptoms that started in the past 3-5 days.
Have had a positive COVID-19 test or are willing to have a rapid antigen test (free if eligible).
Do not have chronic liver or kidney disease.
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 firstname.lastname@example.org and someone will assist you.