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《MedRxiv，4月16日，（第2版更新）Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus infection》

  • 来源专题：COVID-19科研动态监测
  • 编译者： zhangmin
  • 发布时间：2020-04-17

  • 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 Gabriela Silva Borba, Fernando de Almeida Val, Vanderson Sousa Sampaio, Marcia Almeida Ara&uacutejo Alexandre, Gisely Cardoso Melo, Marcelo Brito, Maria Paula Gomes Mour&atildeo, Jos&eacute Diego Brito Sousa, Djane Clarys Baia-da-Silva, Marcus Vinitius Farias Guerra, Ludhmila Abrahāo Hajjar, Rosemary Costa Pinto, Antonio Alcirley Silva Balieiro, Felipe Gomes Naveca, Mariana Simāo Xavier, Alexandre Salomão, André Machado Siqueira, Alexandre Schwarzbolt, Júlio Henrique Rosa Croda, Maurício Lacerda Nogueira, Gustavo Adolfo Sierra Romero, Quique Bassat, Cor Jesus Fontes, Bernardino Cláudio Albuquerque, Cláudio Tadeu Daniel-Ribeiro, Wuelton Marcelo Monteiro, Marcus Vinícus Guimarães Lacerda, CloroCovid-19 Team

    doi: https://doi.org/10.1101/2020.04.07.20056424

    Abstract

    Background There is no specific antiviral therapy recommended for the disease caused by SARS-CoV-2 (COVID-19). Recent publications have drawn attention to the possible benefit of chloroquine (CQ). Our study aimed to comprehensively evaluate the safety and efficacy of two different CQ dosages in patients with established severe COVID-19. Methods We performed a parallel, double-blinded, randomized, phase IIb clinical trial, aiming to assess safety and efficacy of two different CQ dosages as adjunctive therapy of hospitalized patients with SARS in Manaus, Brazilian Amazon. Eligible participants were allocated to receive orally or via nasogastric tube high dose CQ (600mg CQ twice daily for 10 days or total dose 12g); or low dose CQ (450mg for 5 days, twice daily only on the first day, or total dose 2.7g). In addition, all patients received ceftriaxone and azithromycin. This study was registered with ClinicalTrials.gov, number NCT04323527. Findings Out of a pre-defined 440 patients sample size, 81 patients were enrolled.

    *注，本文为预印本论文手稿，是未经同行评审的初步报告，其观点仅供科研同行交流，并不是结论性内容，请使用者谨慎使用.

  • 原文来源：https://www.medrxiv.org/content/10.1101/2020.04.07.20056424v2
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  • 《JAMA，4月24日，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》
    • 来源专题：COVID-19科研动态监测
    • 编译者：xuwenwhlib
    • 发布时间：2020-04-25
    • 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 Mayla Gabriela Silva Borba, MD1,2; Fernando Fonseca Almeida Val, PhD1,2; Vanderson Souza Sampaio, PhD1,2,3; et alMarcia Almeida Araújo Alexandre, MD1; Gisely Cardoso Melo, PhD1,2; Marcelo Brito, MSc1,2; Maria Paula Gomes Mourão, MD1,2; José Diego Brito-Sousa, MSc1,2; Djane Baía-da-Silva, PhD1,2; Marcus Vinitius Farias Guerra, MD1; Ludhmila Abrahão Hajjar, MD4; Rosemary Costa Pinto, BSc3; Antonio Alcirley Silva Balieiro, MSc5; Antônio Guilherme Fonseca Pacheco, MD6; James Dean Oliveira Santos Jr, PhD7; Felipe Gomes Naveca, PhD5; Mariana Simão Xavier, MSc8; André Machado Siqueira, MD8; Alexandre Schwarzbold, MD9; Júlio Croda, MD10,11; Maurício Lacerda Nogueira, MD12; Gustavo Adolfo Sierra Romero, MD13; Quique Bassat, MD14,15,16,17,18; Cor Jesus Fontes, MD19; Bernardino Cláudio Albuquerque, MD20; Cláudio-Tadeu Daniel-Ribeiro, MD21; Wuelton Marcelo Monteiro, PhD1,2; Marcus Vinícius Guimarães Lacerda, MD1,2,5; for the CloroCovid-19 Team Author Affiliations JAMA Netw Open. 2020;3(4.23):e208857. doi:10.1001/jamanetworkopen.2020.8857 Abstract Importance 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. Objective To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. Design, Setting, and Participants 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.
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  • 《MedRxiv，4月16日，（第2版更新）A serological assay to detect SARS-CoV-2 seroconversion in humans》
    • 来源专题：COVID-19科研动态监测
    • 编译者：zhangmin
    • 发布时间：2020-04-17
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