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suck abstract from ncbi


10.1186/s13063-020-04436-6

http://scihub22266oqcxt.onion/10.1186/s13063-020-04436-6
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32493475!7267766!32493475
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suck abstract from ncbi


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pmid32493475      Trials 2020 ; 21 (1): 466
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  • A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial #MMPMID32493475
  • Garcia IG; Rodriguez-Rubio M; Mariblanca AR; de Soto LM; Garcia LD; Villatoro JM; Parada JQ; Meseguer ES; Rosales MJ; Gonzalez J; Arribas JR; Carcas AJ; de la Oliva P; Borobia AM
  • Trials 2020[Jun]; 21 (1): 466 PMID32493475show ga
  • OBJECTIVES: Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Secondary objectives: To evaluate the efficacy of melatonin as a prophylactic treatment on prevention of asymptomatic SARS-CoV-2 infection.To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.To evaluate the duration of COVID-19 symptoms in participants receiving melatonin before the infection.To evaluate seroconversion timing post-symptom onset. Exploratory objectives:To compare severity of COVID-19 between men and women.To evaluate the influence of sleep and diet on prevention from SARS-CoV-2 infection.To evaluate the effect of melatonin on the incidence and characteristics of lymphopenia and increase of inflammatory cytokines related to COVID-19. TRIAL DESIGN: This is a two-arm parallel randomised double-blind controlled trial to evaluate the efficacy of melatonin versus placebo in the prophylaxis of coronavirus disease 2019 among healthcare workers. PARTICIPANTS: Inclusion Criteria: Male or female participants >/= 18 and /= 50 years old). The randomisation sequence was created using SAS version 9.4 statistical software (procedure 'PROC PLAN') with a 1:1 allocation. No randomisation seed was specified. The randomisation seed was generated taking the hour of the computer where the program was executed. Randomization will be done centrally through the electronic system RedCAP(R) in order to conceal the sequence until interventions are assigned BLINDING (MASKING): Participants, caregivers, and those assessing the outcomes are blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm. TRIAL STATUS: Protocol version 3.0, 17th of April 2020. Recruitment ongoing. First participant was recruited on the 21st of April 2020. The final participant is anticipated to be recruited on the 31st of May 2020. As of May 18th, 2020, a total of 312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofia and 73 at Hospital 12 de Octubre). TRIAL REGISTRATION: EU Clinical Trials Register: 2020-001530-35; Date of trial registration: 13th of April 2020; https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001530-35/ES FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
  • |*Occupational Health[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Antibodies, Viral/blood[MESH]
  • |Antiviral Agents/*administration & dosage/adverse effects[MESH]
  • |Betacoronavirus/*drug effects/immunology/pathogenicity[MESH]
  • |COVID-19[MESH]
  • |Chemoprevention[MESH]
  • |Coronavirus Infections/blood/diagnosis/transmission/virology[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Infectious Disease Transmission, Patient-to-Professional/*prevention & control[MESH]
  • |Male[MESH]
  • |Melatonin/*administration & dosage/adverse effects[MESH]
  • |Middle Aged[MESH]
  • |Multicenter Studies as Topic[MESH]
  • |Occupational Exposure/*adverse effects[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/blood/diagnosis/transmission/virology[MESH]
  • |Randomized Controlled Trials as Topic[MESH]
  • |Risk Assessment[MESH]
  • |Risk Factors[MESH]
  • |SARS-CoV-2[MESH]
  • |Seroconversion[MESH]
  • |Spain[MESH]
  • |Time Factors[MESH]
  • |Treatment Outcome[MESH]


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