Efficacy of Chloroquine and Lopinavir/Ritonavir in mild/general COVID-2019: a prospective, open-label, multicenter randomized controlled clinical study
Abstract Background The outbreak of novel coronavirus pneumonia is very serious, and no effective antiviral treatment has been confirmed. The fresh drug research and development cycle is too long to meet clinical emergency needs, and "old drugs and brand new applications" have a huge therapeutic potential. During our previous treatment, we found that the lopinavir/ritonavir treatment recommended in the Fifth edition of the treatment plan had little effect. Earlier studies have shown that chloroquine can inhibit coronavirus replication through multiple mechanisms. Our previous use of chloroquine to treat patients with SARS-CoV-2(novel coronavirus)-infected pneumonia has a higher negative rate of nucleic acid in throat swabs within 5 days after administration than that using lopinavir/ritonavir. However, the half-life and side effects of chloroquine vary greatly among individuals. Methods/design We plan to conduct a prospective, open-label, multicenter randomized controlled, comprehensive treatment clinical study. The study consisted of three phases: a screening period of 1-110 days, a treatment period of no more than 28 days, and a follow-up period of 1 month. Participants will be assessed at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 21, and 28 after the intervention begins. In this study, chloroquine and lopinavir/ritonavir tablets were used to treat patients with eligible novel coronavirus pneumonia diagnosed at various centers between February 12, 2020 and May 31, 2020. The efficacy and safety of chloroquine and lopinavir/ritonavir are to be evaluated. At the same time, explore the correlation between patient genetic polymorphisms and chloroquine steady-state concentration, therapeutic effects and adverse reactions in the body. It is an anti-virus for pneumonitis caused by novel coronavirus. The optimization and update of the antiviral treatment plan provides evidence-based evidence. Disscussion Our study is a prospective, open-label, multicenter randomized controlled, comprehensive treatment clinical study to evaluate the efficacy and safety of chloroquine phosphate and lopinavir/ritonavir in patients with mild/general COVID-2019. The results of this study will provide valuable clinical evidence for the treatment of novel coronavirus pneumonia..
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Preprint| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ResearchSquare.com - (2022) vom: 28. Juli Zur Gesamtaufnahme - year:2022 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Liu, Xi [VerfasserIn] |
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| doi: |
10.21203/rs.3.rs-16392/v1 |
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| PPN (Katalog-ID): |
XRA034076034 |
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| 245 | 1 | 0 | |a Efficacy of Chloroquine and Lopinavir/Ritonavir in mild/general COVID-2019: a prospective, open-label, multicenter randomized controlled clinical study |
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| 520 | |a Abstract Background The outbreak of novel coronavirus pneumonia is very serious, and no effective antiviral treatment has been confirmed. The fresh drug research and development cycle is too long to meet clinical emergency needs, and "old drugs and brand new applications" have a huge therapeutic potential. During our previous treatment, we found that the lopinavir/ritonavir treatment recommended in the Fifth edition of the treatment plan had little effect. Earlier studies have shown that chloroquine can inhibit coronavirus replication through multiple mechanisms. Our previous use of chloroquine to treat patients with SARS-CoV-2(novel coronavirus)-infected pneumonia has a higher negative rate of nucleic acid in throat swabs within 5 days after administration than that using lopinavir/ritonavir. However, the half-life and side effects of chloroquine vary greatly among individuals. Methods/design We plan to conduct a prospective, open-label, multicenter randomized controlled, comprehensive treatment clinical study. The study consisted of three phases: a screening period of 1-110 days, a treatment period of no more than 28 days, and a follow-up period of 1 month. Participants will be assessed at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 21, and 28 after the intervention begins. In this study, chloroquine and lopinavir/ritonavir tablets were used to treat patients with eligible novel coronavirus pneumonia diagnosed at various centers between February 12, 2020 and May 31, 2020. The efficacy and safety of chloroquine and lopinavir/ritonavir are to be evaluated. At the same time, explore the correlation between patient genetic polymorphisms and chloroquine steady-state concentration, therapeutic effects and adverse reactions in the body. It is an anti-virus for pneumonitis caused by novel coronavirus. The optimization and update of the antiviral treatment plan provides evidence-based evidence. Disscussion Our study is a prospective, open-label, multicenter randomized controlled, comprehensive treatment clinical study to evaluate the efficacy and safety of chloroquine phosphate and lopinavir/ritonavir in patients with mild/general COVID-2019. The results of this study will provide valuable clinical evidence for the treatment of novel coronavirus pneumonia. | ||
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| 700 | 1 | |a Shang, Yuqi |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Hongqiong |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Gongqi |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yuanli |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Shaoxuan |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Yaoyong |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Mingxing |e verfasserin |4 aut | |
| 700 | 1 | |a Hong, Zhongsi |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Jinyu |e verfasserin |4 aut | |
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