A Phase 2 interventional study of Melatonin intravenous and Placebo intravenous in COVID-19, SARS-CoV 2 and Coronavirus Infection, sponsored by Pharmamel S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Pharmamel S.L. · Phase 2, Interventional, and Treatment
There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.
ICU COVID-19 patients show high risk of death mainly due to sepsis and respiratory disfunction. Prevention of these critical conditions is mandatory to reduce mortality and to improve patient's outcome.
Melatonin is an endogenous hormone involved not only in circadian rhythm control, but also in the cell protection due to its outstanding anti-inflammatory and antioxidative effects. High doses of melatonin have shown high efficacy against bacterial (sepsis) and viral infections. Melatonin is a safe product that consistently has shown lack of side-effects when it is administered to humans.
SARS-CoV 2 infection may yield severe forms of the disease that require the patients admission to the ICU. These patients may develop an excessive inflammatory response and a burst of free radicals, constituting the major cause of death in these subjects.
Our hypothesis is that high doses of melatonin intravenously administered to COVID-19 ICU patients might reach enough blood levels able to prevent/counteract the developing of sepsis and the production of free radicals, reducing mortality and hospital stay.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Pharmamel S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(12 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.
Drug: Melatonin intravenous
(6 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
Drug: Placebo intravenous
7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.
7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
Mortality
Mortality in each study group represented in frequency and time-to-event at day 28 after randomization
Time frame: one month
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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