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
Metadatos
Mostrar el registro completo del ítemEditorial
BMC
Materia
COVID-19 Randomized control trial Protocol Melatonin Treatment Intensive care ARDS Inflammation
Fecha
2020Referencia bibliográfica
Rodríguez-Rubio, M., Figueira, J.C., Acuña-Castroviejo, D. et al. 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. Trials 21, 699 (2020). https://doi.org/10.1186/s13063-020-04632-4
Patrocinador
Start-up Pharmamel LTDResumen
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.