Efficacy and safety of Lianhuaqingwen capsules,a repurposed Chinese herb,in patients with coronavirus disease 2019: A multicenter,prospective, randomized controlled trial |
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| Affiliation: | 1. Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035 PR China;2. State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China;3. Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China;4. Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China;5. Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China;6. The First Affiliated Hospital of College of Medicine, Zhejiang province, China;7. The First Teaching Hospital of Tianjin University of traditional Chinese medicine;8. Beijing Hospital of traditional Chinese medicine, Beijing, China;9. Zhongshan Hospital Affiliated Fudan University, Shanghai, China;10. Beijing Ditan Hospital Capital Medical University, Beijing, China;11. Youan Hospital Capital Medical University, Beijing, China;12. Shanghai University of traditional Chinese medicine, Shanghai, China;13. Fuyang Second People''s Hospital, Fuyang, China;14. Wuhan Jinyintan Hospital, Wuhan, Hubei province, China |
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| Abstract: | BackgroundCoronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.PurposeTo determine the safety and efficacy of LH capsule in patients with Covid-19.MethodsWe did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.ResultsWe included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported.ConclusionIn light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19. |
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