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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
dc.contributor.author | Rodríguez Rubio, Miguel | |
dc.contributor.author | Acuña Castroviejo, Darío | |
dc.contributor.author | Escames Rosa, Germaine | |
dc.date.accessioned | 2021-01-26T13:11:42Z | |
dc.date.available | 2021-01-26T13:11:42Z | |
dc.date.issued | 2020 | |
dc.identifier.citation | 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 | es_ES |
dc.identifier.uri | http://hdl.handle.net/10481/66032 | |
dc.description.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. | es_ES |
dc.description.sponsorship | Start-up Pharmamel LTD | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | BMC | es_ES |
dc.rights | Atribución 3.0 España | * |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.subject | COVID-19 | es_ES |
dc.subject | Randomized control trial | es_ES |
dc.subject | Protocol | es_ES |
dc.subject | Melatonin | es_ES |
dc.subject | Treatment | es_ES |
dc.subject | Intensive care | es_ES |
dc.subject | ARDS | es_ES |
dc.subject | Inflammation | es_ES |
dc.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 | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es_ES |
dc.identifier.doi | 10.1186/s13063-020-04632-4 |