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

AbstractObjectives• 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.Trial designPhase II, single center, double-blind, placebo-controlled randomized trial with a two-arm parallel group design and 2:1 allocation ratio.ParticipantsOnly critically ill adult patients that fulfil...
Source: Trials - Category: Research Source Type: clinical trials