@misc{10481/66032,
year = {2020},
url = {http://hdl.handle.net/10481/66032},
abstract = {Objectives:
• Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to
the intensive care unit (ICU) with COVID-19.
• Secondary objectives:
◦ To evaluate the effect of IVM on ICU length of stay.
◦ To evaluate the effect of IVM on the length of mechanical ventilation (MV).
◦ To evaluate if the use of IVM is associated with an increase in the number of ventilator-free days.
◦ To evaluate if the use of IVM is associated with a reduced number of failing organs as determined by the
sequential organ failure assessment (SOFA) scale.
◦ To evaluate if the use of IVM is associated with a reduction of the frequency and severity of COVID-19-associated
thromboembolic phenomena.
◦ To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6.
◦ To evaluate if the use of IVM is associated with an improvement in hematologic parameters.
◦ To evaluate if the use of IVM is associated with an improvement in biochemical parameters.
◦ To evaluate if the use of IVM is associated with an improvement in blood gas analysis parameters.
◦ To evaluate adverse events during the 28 day study period.},
organization = {Start-up Pharmamel LTD},
publisher = {BMC},
keywords = {COVID-19},
keywords = {Randomized control trial},
keywords = {Protocol},
keywords = {Melatonin},
keywords = {Treatment},
keywords = {Intensive care},
keywords = {ARDS},
keywords = {Inflammation},
title = {A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial},
doi = {10.1186/s13063-020-04632-4},
author = {Rodríguez Rubio, Miguel and Acuña Castroviejo, Darío and Escames Rosa, Germaine},
}