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 interventions tested in this study were based on different regimens using CQ 150mg tablets (Farmanguinhos, Fiocruz, Brazil). Eligible participants were allocated at a 1:1 ratio to receive orally (or via nasogastric tube in case of orotracheal intubation) either: a) high dosage CQ (600mg CQ (4x150mg tablets, twice daily for 10 days, total dose 12g); or b) low dosage CQ (450mg CQ (3x150mg tablets + 1 placebo) twice daily on day 0, 3x150mg tablets +1 placebo tablet followed by 4 placebo tablets from D1 to D4, and then 4 placebo tablets twice daily from D5-D9, total dose 2.7g). Placebo tablets also produced by Farmanguinhos were . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.