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Title: Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.
Author: Silva Borba, Mayla Gabriela
Fonseca Almeida Val, Fernando
Souza Sampaio, Vanderson de
Almeida Araújo Alexandre, Marcia
Cardoso de Melo, Gisely
Brito, Marcelo
Gomes Mourão, Maria Paula
Brito-Sousa, José Diego
Baía-da-Silva, Djane
Farias Guerra, Marcus Vinitius
Hajjar, Ludhmila A.
Costa Pinto, Rosemary
Silva Balieiro, Antonio A.
Fonseca Pacheco, Antonio G.
Oliveira Santos, James Dean
Gomes Naveca, Felipe
Simao Xavier, Mariana
Machado Siqueira, André
Schwarzbold, Alexandre
Croda, Júlio
Lacerda Nogueira, Mauricio
Sierra Romero, Gustavo A.
Bassat Orellana, Quique
Fontes, Cor Jesus
Albuquerque, Bernardino C.
Daniel-Ribeiro, Claudio-Tadeu
Monteiro, Wuelton Marcelo
Guimaraes Lacerda, Marcus V.
CloroCovid-19 Team
Keywords: SARS-CoV-2
Issue Date: 24-Apr-2020
Publisher: Chicago, IL : American Medical Association, [2018]-
Abstract: There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug.To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon. - Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days). - Label: Main Outcomes and Measures Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4. Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%). - Label: Conclusions and Relevance The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19.
Note: Reproducció del document publicat a: 10.1001/jamanetworkopen.2020.8857
It is part of: JAMA network open , 2020 , vol. 3 , num. 4, p.e208857
Related resource: 10.1001/jamanetworkopen.2020.8857
ISSN: 2574-3805
Appears in Collections:Articles publicats en revistes (ISGlobal)

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