Miniatura

Fitxers

Borba_MGS_JAMA_Netw_Open_2020.pdf (1.01 MB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2020-04-24

Llicència de publicació

cc by (c) Silva et al., 2020
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/162633

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.

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

http://dx.doi.org/ 10.1001/jamanetworkopen.2020.8857

Resum

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.

Matèries

SARS-CoV-2, COVID-19

Matèries (anglès)

SARS-CoV-2, COVID-19

Citació

Col·leccions

Articles publicats en revistes (ISGlobal)

Citació

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, Julio, 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. 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.. _JAMA network open _. 2020. Vol. 3, núm. 4, pàgs. e208857. [consulta: 7 de febrer de 2026]. ISSN: 2574-3805. [Disponible a: https://hdl.handle.net/2445/162633]

Exportar metadades

JSON - METS

Compartir registre