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

The fatality rate in our sample was 27% (95%CI=17.9-38.2%), therefore still overlapping with the CI of the meta-analysis based on two major studies, which used similar patients without CQ (95%CI=14.5-19.2%). Survival per arm was presented in comparison to historical collation of available data from two other similar lethality studies with patients not receiving CQ ( Figure 2 ). Both arms were very similar to these data showing no clear differences, despite more deaths in the higher dosage CQ arm (p=0.03). A subgroup was analysed with critically-ill patients enrolled, and compared to the large historical sample-size cohort of patients in Lombardy, Italy (Figure 3 ). No differences were seen between groups, but fatality seemed to be higher than in Italy, where patients were not using CQ. Only two out of 22 deaths were in older than 75 years-old. Nineteen out of 22 deaths had virological confirmation antemortem.