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

Hospitalized patients aged 18 years or older at the time of inclusion, with respiratory rate higher than 24 rpm AND/OR heart rate higher than 125 bpm (in the absence of fever) AND/OR peripheral oxygen saturation lower than 90% in ambient air AND/OR shock (defined as mean arterial pressure lower than 65 mmHg, with the need for vasopressors medicines or oliguria or a lower level of consciousness) were included. Children under 18 years of age were not included due to the known lower morbidity/mortality from COVID-19 33 . Patients were enrolled before laboratorial confirmation of COVID-19, considering that such procedure could delay randomization. For the analyses at this point, all patients were included regardless of the confirmed etiology which for safety issues (the focus of this manuscript) should not be an issue. For now, the flowchart of the study presents clinicalepidemiological suspected cases and cases already confirmed by RT-PCR.