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)

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

CloroCovid-19 was a parallel, double-blind, randomized, phase IIb clinical trial, which started on March 23 rd , 2020, aiming to assess safety and efficacy of CQ in the treatment of hospitalized patients with severe respiratory syndrome secondary to SARS-CoV-2 infection Manaus is the capital of the Amazonas State, the biggest Brazilian State, and has ~2.5 million inhabitants scattered in the ninth largest country subdivision of the world (>1.5M/km 2 ). It is a major industrial, academic and tourist centre in the Amazon region, with several transportation hubs and thousands of annual foreign visitors. It is mostly served by the socialized and free Unified Health System (SUS) in an organized health assistance network, but also counts with many private hospitals. The city also counts with various universities, graduate programs and traditional clinical research groups dedicated to the study of infectious diseases. At the beginning of the study, autochthonous SARS-CoV-2 transmission had already been recorded at the study site.