Author: Mayla Borba; Fernando de Almeida Val; Vanderson Sousa Sampaio; Marcia Araujo Alexandre; Gisely Cardoso Melo; Marcelo Brito; Maria Mourao; Jose Diego Brito Sousa; djane Baia-da-Silva; Marcus Vinitius Farias Guerra; Ludhmila Hajjar; Rosemary Costa Pinto; Antonio Balieiro; Felipe Gomes Naveca; Mariana Xavier; Alexandre Salomao; Andre Siqueira; Alexandre Schwarzbolt; Julio Henrique Rosa Croda; Mauricio Lacerda Nogueira; Gustavo Romero; Quique Bassat; Cor Jesus Fontes; Bernardino Albuquerque; Claudio Daniel-Ribeiro; Wuelton Monteiro; Marcus Lacerda
Title: Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study) Document date: 2020_4_11
ID: ifxm3j4y_29
Snippet: (CONEP approval 3.929.646/2020). All patients and/or legal representatives in case of unconsciousness, were informed about objectives and risks of participation. They were given time to carefully read and then sign an informed consent form (ICF). After recovery, the patient also signed the ICF. Random online clinical monitoring and quality control was performed. A virtual independent Data Safety and Monitoring Board (DSMB), with epidemiologists, .....
Document: (CONEP approval 3.929.646/2020). All patients and/or legal representatives in case of unconsciousness, were informed about objectives and risks of participation. They were given time to carefully read and then sign an informed consent form (ICF). After recovery, the patient also signed the ICF. Random online clinical monitoring and quality control was performed. A virtual independent Data Safety and Monitoring Board (DSMB), with epidemiologists, clinicians and experts in infectious diseases, was timely implemented to review the protocol and with daily meetings to follow-up the activities of the study. The trial was reported according to Consolidated Standards of Reporting Trials (Consort) statement. 32
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