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Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial

BACKGROUND: A wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly resulted in a steep increase in the infected population and an overloaded healthcare system. Effective medications for Omicron are currently limited. The previous observational study supports t...

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Autores principales: Xu, Xiangru, Zhou, Shuang, Chen, Caiyu, Li, Jinhua, Wu, Hongze, Jin, Guoqiang, Zhou, Jing, Wang, Gang, Cao, Min, Sun, Ding, Zhang, Wen, Peng, Wei, Pu, Yuting, Sun, Yuting, Fang, Bangjiang, Xu, Jianguang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier GmbH. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9616513/
https://www.ncbi.nlm.nih.gov/pubmed/36334390
http://dx.doi.org/10.1016/j.phymed.2022.154514
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author Xu, Xiangru
Zhou, Shuang
Chen, Caiyu
Li, Jinhua
Wu, Hongze
Jin, Guoqiang
Zhou, Jing
Wang, Gang
Cao, Min
Sun, Ding
Zhang, Wen
Peng, Wei
Pu, Yuting
Sun, Yuting
Fang, Bangjiang
Xu, Jianguang
author_facet Xu, Xiangru
Zhou, Shuang
Chen, Caiyu
Li, Jinhua
Wu, Hongze
Jin, Guoqiang
Zhou, Jing
Wang, Gang
Cao, Min
Sun, Ding
Zhang, Wen
Peng, Wei
Pu, Yuting
Sun, Yuting
Fang, Bangjiang
Xu, Jianguang
author_sort Xu, Xiangru
collection PubMed
description BACKGROUND: A wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly resulted in a steep increase in the infected population and an overloaded healthcare system. Effective medications for Omicron are currently limited. The previous observational study supports the efficacy and safety of Reyanning (RYN) mixture in the treatment of coronavirus disease 2019 (COVID-19). PURPOSE: To evaluate the efficacy of RYN in asymptomatic and mildly infected patients with SARS-CoV-2 infection. STUDY DESIGN AND METHODS: This study was a prospective, open‐label, randomized controlled trial. We consecutively recruited 2830 patients from Shanghai New International Expo Center mobile cabin hospital and randomized them in a 1:1 ratio to receive RYN plus standard care or receive standard care alone. The primary outcomes were the negative conversion of nucleic acid. Secondary outcomes included the hospital duration, new-onset symptoms, proportion of disease progression, and the viral load measured by the cycle threshold (Ct) value. RESULTS: A total of 1393 patients in the intervention group and 1407 patients in the control group completed the study. The negative conversion time of nucleic acid was significantly shortened in the intervention group (median: 6 d vs. 7 d, Hazard ratio: 0.768, 95CI %: 0.713-0.828, p < 0.0001). The negative conversion rate of nucleic acid was significantly higher in the intervention group (Day 3: 32.4% vs. 18.3%; Day7: 65.3% vs. 55.2%, p < 0.001). The hospitalization duration was significantly shortened in the intervention group (median: 8 d vs. 9 d, Hazard ratio: 0.759, 95% CI: 0.704-0.818, p < 0.0001). The proportion of new-onset fever (2.4% vs. 4.1%, p = 0.012), coughing (12.2% vs. 14.8%, p = 0.046), and expectoration (6.0% vs. 8.0%, p = 0.032) in the intervention group was significantly lower. RYN treatment increased Ct values and reduced the viral load. No disease progression and serious adverse events were reported during the study. CONCLUSION: RYN is a safe and effective treatment that can accelerate virus clearance and promote disease recovery in asymptomatic and mild Omicron infections.
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spelling pubmed-96165132022-10-31 Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial Xu, Xiangru Zhou, Shuang Chen, Caiyu Li, Jinhua Wu, Hongze Jin, Guoqiang Zhou, Jing Wang, Gang Cao, Min Sun, Ding Zhang, Wen Peng, Wei Pu, Yuting Sun, Yuting Fang, Bangjiang Xu, Jianguang Phytomedicine Original Article BACKGROUND: A wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly resulted in a steep increase in the infected population and an overloaded healthcare system. Effective medications for Omicron are currently limited. The previous observational study supports the efficacy and safety of Reyanning (RYN) mixture in the treatment of coronavirus disease 2019 (COVID-19). PURPOSE: To evaluate the efficacy of RYN in asymptomatic and mildly infected patients with SARS-CoV-2 infection. STUDY DESIGN AND METHODS: This study was a prospective, open‐label, randomized controlled trial. We consecutively recruited 2830 patients from Shanghai New International Expo Center mobile cabin hospital and randomized them in a 1:1 ratio to receive RYN plus standard care or receive standard care alone. The primary outcomes were the negative conversion of nucleic acid. Secondary outcomes included the hospital duration, new-onset symptoms, proportion of disease progression, and the viral load measured by the cycle threshold (Ct) value. RESULTS: A total of 1393 patients in the intervention group and 1407 patients in the control group completed the study. The negative conversion time of nucleic acid was significantly shortened in the intervention group (median: 6 d vs. 7 d, Hazard ratio: 0.768, 95CI %: 0.713-0.828, p < 0.0001). The negative conversion rate of nucleic acid was significantly higher in the intervention group (Day 3: 32.4% vs. 18.3%; Day7: 65.3% vs. 55.2%, p < 0.001). The hospitalization duration was significantly shortened in the intervention group (median: 8 d vs. 9 d, Hazard ratio: 0.759, 95% CI: 0.704-0.818, p < 0.0001). The proportion of new-onset fever (2.4% vs. 4.1%, p = 0.012), coughing (12.2% vs. 14.8%, p = 0.046), and expectoration (6.0% vs. 8.0%, p = 0.032) in the intervention group was significantly lower. RYN treatment increased Ct values and reduced the viral load. No disease progression and serious adverse events were reported during the study. CONCLUSION: RYN is a safe and effective treatment that can accelerate virus clearance and promote disease recovery in asymptomatic and mild Omicron infections. Elsevier GmbH. 2023-01 2022-10-28 /pmc/articles/PMC9616513/ /pubmed/36334390 http://dx.doi.org/10.1016/j.phymed.2022.154514 Text en © 2022 Elsevier GmbH. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Original Article
Xu, Xiangru
Zhou, Shuang
Chen, Caiyu
Li, Jinhua
Wu, Hongze
Jin, Guoqiang
Zhou, Jing
Wang, Gang
Cao, Min
Sun, Ding
Zhang, Wen
Peng, Wei
Pu, Yuting
Sun, Yuting
Fang, Bangjiang
Xu, Jianguang
Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title_full Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title_fullStr Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title_full_unstemmed Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title_short Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial
title_sort efficacy and safety of reyanning mixture in patients infected with sars-cov-2 omicron variant: a prospective, open-label, randomized controlled trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9616513/
https://www.ncbi.nlm.nih.gov/pubmed/36334390
http://dx.doi.org/10.1016/j.phymed.2022.154514
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