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Efficacy and safety of Xiyanping injection in the treatment of COVID‐19: A multicenter, prospective, open‐label and randomized controlled trial

Zhang et al., Phytotherapy Research, doi:10.1002/ptr.7141, NCT04295551
May 2021  
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Severe case 92% Improvement Relative Risk Recovery 48% Recovery, fever 40% Recovery, cough 61% Viral clearance 53% Andrographolide  Zhang et al.  LATE TREATMENT  RCT Is late treatment with andrographolide beneficial for COVID-19? RCT 130 patients in China (January - February 2020) Lower severe cases (p=0.028) and improved recovery (p=0.008) c19early.org Zhang et al., Phytotherapy Research, May 2021 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
RCT 130 hospitalized COVID-19 patients in China, showing lower progression and improved recovery with Xiyanping injection (9-dehydro-17-hydro-andrographolide and sodium 9-dehydro-17-hydro-andrographolide-19-yl sulfate, which are derived from andrographis).
risk of severe case, 92.3% lower, RR 0.08, p = 0.03, treatment 0 of 65 (0.0%), control 6 of 65 (9.2%), NNT 11, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of no recovery, 48.2% lower, HR 0.52, p = 0.008, treatment 65, control 65, inverted to make HR<1 favor treatment.
risk of no recovery, 40.1% lower, HR 0.60, p = 0.07, treatment 65, control 65, inverted to make HR<1 favor treatment, fever.
risk of no recovery, 60.9% lower, HR 0.39, p = 0.001, treatment 65, control 65, inverted to make HR<1 favor treatment, cough.
risk of no viral clearance, 53.5% lower, HR 0.47, p < 0.001, treatment 65, control 65, inverted to make HR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Zhang et al., 12 May 2021, Randomized Controlled Trial, China, peer-reviewed, mean age 46.3, 12 authors, study period 27 January, 2020 - 20 February, 2020, trial NCT04295551 (history). Contact: xqyencu@gmail.com.
This PaperAndrographol..All
Efficacy and safety of Xiyanping injection in the treatment of COVID ‐19: A multicenter, prospective, open‐label and randomized controlled trial
Xin‐yi Zhang, Lang Lv, Yu‐long Zhou, Liang‐dong Xie, Qin Xu, Xiao‐fan Zou, Yan Ding, Jie Tian, Jia‐liang Fan, Hai‐wei Fan, Yi‐xi Yang, Xiao‐qun Ye
Phytotherapy Research, doi:10.1002/ptr.7141
Xiyanping (XYP) is a Chinese herbal medicine used in the clinic to treat respiratory infection and pneumonia. Recent evidence identified XYP as a potential inhibitor of severe acute respiratory syndrome coronavirus 2, implying XYP as a possible treatment for the coronavirus disease 2019 . Here, we conducted a prospective, multicenter, open-label and randomized controlled trial to evaluate the safety and effectiveness of XYP injection in patients with mild to moderate COVID-19. We consecutively recruited 130 COVID-19 patients with mild to moderate symptoms from five study sites, and randomized them in 1:1 ratio to receive XYP injection in combination with standard therapy or receive standard supportive therapy alone. We found that XYP injection significantly reduced the time to cough relief, fever resolution and virus clearance. Less patients receiving XYP injection experienced disease progression to the severe stage during the treatment process. No severe adverse events were reported during the study. Taken together, XYP injection is safe and effective in improving the recovery of patients with mild to moderate COVID-19. However, further studies are warranted to evaluate the efficacy of XYP in an expanded cohort comprising COVID-19 patients at different disease stages.
CONFLICT OF INTEREST The authors declare no conflicts of interest. AUTHOR CONTRIBUTIONS Xiao-Qun Ye, Xin-Yi Zhang and Lang Lv: Designed the experiment. Xiao-Qun Ye, Xin-Yi Zhang, Lang Lv, Yu-Long Zhou and Liang-Dong Xie: Collected the data. Qin Xu, Xiao-Fan Zou, Yan Ding, Jie Tian, Jia-Liang Fan, Hai-Wei Fan and Yi-Xi Yang: Contributed to data analysis. All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work. ETHICS STATEMENT The study on human participants was approved by the institutional review board or ethics committee at each participating site. Written informed consent was obtained from all the patients. SUPPORTING INFORMATION Additional supporting information may be found online in the Supporting Information section at the end of this article.
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Late treatment
is less effective
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