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

Autor:	Alberto M. Borobia, Juan Carlos Figueira, Darío Acuña-Castroviejo, M. Rodríguez-Rubio, Germaine Escames, Pedro de la Oliva
Přispěvatelé:	[Rodríguez-Rubio,M, de la Oliva,P] Pediatric Intensive Care Department, Hospital Universitario La Paz, Madrid, Spain. [Rodríguez-Rubio,M, de la Oliva,P] Department of Pediatrics, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. [Figueira,JC] Intensive Care Medicine Department, Hospital Universitario La Paz, Madrid, Spain. [Acuña-Castroviejo,D, Escames,G] Department of Physiology, Faculty of Medicine, Biomedical Research Center, Health Science Technology Park, University of Granada, Granada, Spain. [Acuña-Castroviejo,D, Escames,G] CIBERfes, Ibs Granada, Granada, Spain. [Acuña-Castroviejo,D] Clinical Laboratories, San Cecilio University Hospital, Granada, Spain. [Borobia,AM] Clinical Pharmacology Department, Clinical Trial Unit, Hospital Universitario La Paz – IdiPAZ, Madrid, Spain. [Borobia,AM] School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain., The start-up Pharmamel LTD financed the trial.
Jazyk:	angličtina
Rok vydání:	2020
Předmět:	Letter Terapéutica Placebo-controlled study Medicine (miscellaneous) melatonin Ensayo clínico controlado aleatorio Diseases::Virus Diseases::Pneumonia Viral [Medical Subject Headings] law.invention Melatonina Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] 0302 clinical medicine Randomized controlled trial law Analytical Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization::Length of Stay [Medical Subject Headings] Protocol Medicine Pharmacology (medical) 030212 general & internal medicine Randomized Controlled Trials as Topic intensive care Melatonin Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings] lcsh:R5-920 treatment Protocolo de ensayo clínico Intensive care unit Intensive Care Units Randomized Controlled Trial embryonic structures Diseases::Respiratory Tract Diseases::Respiration Disorders::Respiratory Distress Syndrome Adult [Medical Subject Headings] Administration Intravenous lcsh:Medicine (General) Coronavirus Infections Pregnancy test Randomized control trial medicine.medical_specialty Unidades de cuidados intensivos Randomization Infecciones por coronavirus Pneumonia Viral Placebo Health Care::Health Care Facilities Manpower and Services::Health Facilities::Hospital Units::Intensive Care Units [Medical Subject Headings] Betacoronavirus 03 medical and health sciences Double-Blind Method Intensive care Humans protocol Pandemics Inflammation Inflamación SARS-CoV-2 business.industry urogenital system Health Care::Environment and Public Health::Public Health::Disease Outbreaks::Epidemics::Pandemics [Medical Subject Headings] COVID-19 Length of Stay Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings] Clinical trial Treatment inflammation Emergency medicine Síndrome de dificultad respiratoria del adulto ARDS Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method [Medical Subject Headings] business Analytical Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Administration Intravenous [Medical Subject Headings] Chemicals and Drugs::Hormones Hormone Substitutes and Hormone Antagonists::Hormones::Melatonin [Medical Subject Headings] 030217 neurology & neurosurgery
Zdroj:	Digibug: Repositorio Institucional de la Universidad de Granada Universidad de Granada (UGR) Trials Trials, Vol 21, Iss 1, Pp 1-3 (2020) Digibug. Repositorio Institucional de la Universidad de Granada instname
Popis:	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. Start-up Pharmamel LTD
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e8180f5f23e43394b12631dbf0137a4 http://hdl.handle.net/10481/66032 Zobrazit plný text záznamu