Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group de...Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19.According to the 1:1 ratio between the study groups(ivermectin group and standard treatment group),patients were randomly admitted to each intervention arm.Results:The mean age of the participants in the ivermectin group was(48.37±13.32)years.Eighteen of them were males(54.5%)and the participants in the control group had a mean age of(46.28±14.47)years,with nineteen of them being males(59.4%).As a primary outcome,after 5 days of randomization,there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital(P=0.168).ICU admission(P=0.764),length of stay in ICU(P=0.622),in-hospital mortality(P=0.427),adverse drug reactions,and changes in the mean difference of laboratory data had not any significant difference between the two groups(except for urea change).In addition,the radiologic findings of the two groups of patients were not significantly different.Linear regression analysis showed that for every 10 years increase of age,0.6 day of hospitalization duration was increased.There was no statistically significant association between other variables and clinical outcomes.Conclusions:Among adult hospitalized patients with moderate to severe COVID-19,there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement,and mortality of the participants.展开更多
<em>Background</em>: The aim of this study was to test Viusid and Asbrip as adjuvants to the standard treatment of patients with COVID-19 disease which could favor the recovery of the patients and reduce t...<em>Background</em>: The aim of this study was to test Viusid and Asbrip as adjuvants to the standard treatment of patients with COVID-19 disease which could favor the recovery of the patients and reduce the hospitalization days.<em> Design</em>: This is a randomized, open-label, controlled trial to determine the efficacy and safety of Viusid and Asbrip in hospitalized patients with mild to moderate symptoms of COVID-19. <em>Material and Methods</em>: A total of 60 patients with proven COVID-19 disease by PCR test were randomized in a 2:1 ratio. In the active group 40 patients received oral doses of Viusid (30 ml TID) and Asbrip (10 ml TID) plus standard treatment. The control group consisted of 20 patients receiving only standard treatment. The trial began with hospitalization, followed by home treatment for a total of 21 days. Four symptoms were followed: fever, dyspnea, cough and fatigue, assessed by score 0 - 3: 0 = well, 1 = mild, 2 = moderate, 3 = severe, with total sum, Composite Symptom Score (CSS) from 0 to 12. <em>Results</em>: The 21 days diagram of CSS shows statistically better results of Viusid-Asbrip group vs. Control group from day 4 to day 21. Time to semi-recovery in days, assessed by 50% of CSS, is better in Viusid-Asbrip group vs. Control group (6.07 ± 2.77 vs. 8.35 ± 2.94, p = 0.02). Time to recovery in days respectively is (14.05 ± 4.15 vs. 19.25 ± 2.12, p = 0.0001). And Hospitalization days are (9.05 ± 2.58 vs. 12.75 ± 4.44, p = 0.0003). <em>Conclusion</em>: This trial shows that adding of Viusid & Asbrip to the treatment of COVID-19 can contribute to faster recovery of the patients, decreasing of the hospital stay and milder course of the disease.展开更多
Objective Phillyrin(KD-1)is a traditional Chinese monomer and the main active component in Lianhua Qingwen.At present,sufficient studies have confirmed that KD-1 has significant anti-SARS-CoV-2 activity and antiinflam...Objective Phillyrin(KD-1)is a traditional Chinese monomer and the main active component in Lianhua Qingwen.At present,sufficient studies have confirmed that KD-1 has significant anti-SARS-CoV-2 activity and antiinflammatory effects in vitro and in vivo.However,evidence-based studies to evaluate its therapeutic effect on COVID-19 are lacking.Therefore,we designed a clinical trial to evaluate the efficacy and safety of KD-1 in the treatment of moderate COVID-19 infection.Methods This is a multicenter,randomized,double-blind,placebo-controlled clinical trial.A total of 120 participants will be recruited and randomized to receive KD-1 capsule or placebo treatment for 14 days,50 mg per capsule,four capsules each time,three times a day.If the SARS-CoV-2 nucleic acid test results are negative twice within 14 days,the KD-1 capsule will be stopped the following day.Symptoms,patient compliance,and adverse reactions will be recorded,and nucleic acid testing will be conducted daily.Primary and secondary outcomes,as well as safety indicators,will be used to evaluate the efficacy and safety of the KD-1 capsule in the treatment of COVID-19.Discussion Herein,we describe the first clinical trial in China to treat COVID-19 using a traditional Chinese medicine monomer.A randomized,double-blind,placebo-controlled clinical trial is the best way to evaluate the efficacy and safety of KD-1 against moderate COVID-19 infection.If a good clinical benefit is observed,this represents the first step toward the use of KD-1 capsules to treat COVID-19.This clinical trial can serve as a model for other evidence-based research of traditional herbal medicines.Trial registration This study is registered at chinadrugtrials.org.cn,with registration number:CTR20211800.展开更多
目的观察温针灸联合刺络拔罐治疗轻型新型冠状病毒(corona virus disease 2019,COVID-19)感染患者的临床疗效。方法将82例COVID-19轻型患者随机分为治疗组和对照组,每组41例。对照组予连花清瘟颗粒口服,治疗组在对照组基础上给予温针灸...目的观察温针灸联合刺络拔罐治疗轻型新型冠状病毒(corona virus disease 2019,COVID-19)感染患者的临床疗效。方法将82例COVID-19轻型患者随机分为治疗组和对照组,每组41例。对照组予连花清瘟颗粒口服,治疗组在对照组基础上给予温针灸联合刺络拔罐治疗。比较两组退热时间,两组治疗前后咳嗽视觉模拟量表(visual analog scale,VAS)、中文版莱塞斯特咳嗽生命质量问卷(Mandarin Chinese version of the Leicester cough questionnaire,LCQ-MC)、咽干/痛缓解程度,并比较两组安全性情况,追踪观察两组患者是否出现“长新冠综合征”和COVID-19二次感染情况。结果两组退热时间比较差异有统计学意义(P<0.05)。两组治疗后咳嗽VAS评分低于治疗前,且治疗组低于对照组,差异有统计学意义(P<0.05)。两组治疗后LCQ-MC评分低于治疗前,且治疗组低于对照组,差异有统计学意义(P<0.05)。两组治疗后咽干/痛程度分布优于治疗前,且治疗组优于对照组,差异有统计学意义(P<0.05)。两组“长新冠综合征”发生率比较差异无统计学意义(P>0.05)。两组COVID-19二次感染率比较差异无统计学意义(P>0.05)。两组疗法安全性均可。结论在口服中成药的基础上,温针灸联合刺络拔罐治疗COVID-19轻型患者在急性期临床疗效显著,安全性高。展开更多
基金Hormozgan University of Medical Sciences,Bandar Abbas,Iran(grant No.990238)。
文摘Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19.According to the 1:1 ratio between the study groups(ivermectin group and standard treatment group),patients were randomly admitted to each intervention arm.Results:The mean age of the participants in the ivermectin group was(48.37±13.32)years.Eighteen of them were males(54.5%)and the participants in the control group had a mean age of(46.28±14.47)years,with nineteen of them being males(59.4%).As a primary outcome,after 5 days of randomization,there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital(P=0.168).ICU admission(P=0.764),length of stay in ICU(P=0.622),in-hospital mortality(P=0.427),adverse drug reactions,and changes in the mean difference of laboratory data had not any significant difference between the two groups(except for urea change).In addition,the radiologic findings of the two groups of patients were not significantly different.Linear regression analysis showed that for every 10 years increase of age,0.6 day of hospitalization duration was increased.There was no statistically significant association between other variables and clinical outcomes.Conclusions:Among adult hospitalized patients with moderate to severe COVID-19,there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement,and mortality of the participants.
文摘<em>Background</em>: The aim of this study was to test Viusid and Asbrip as adjuvants to the standard treatment of patients with COVID-19 disease which could favor the recovery of the patients and reduce the hospitalization days.<em> Design</em>: This is a randomized, open-label, controlled trial to determine the efficacy and safety of Viusid and Asbrip in hospitalized patients with mild to moderate symptoms of COVID-19. <em>Material and Methods</em>: A total of 60 patients with proven COVID-19 disease by PCR test were randomized in a 2:1 ratio. In the active group 40 patients received oral doses of Viusid (30 ml TID) and Asbrip (10 ml TID) plus standard treatment. The control group consisted of 20 patients receiving only standard treatment. The trial began with hospitalization, followed by home treatment for a total of 21 days. Four symptoms were followed: fever, dyspnea, cough and fatigue, assessed by score 0 - 3: 0 = well, 1 = mild, 2 = moderate, 3 = severe, with total sum, Composite Symptom Score (CSS) from 0 to 12. <em>Results</em>: The 21 days diagram of CSS shows statistically better results of Viusid-Asbrip group vs. Control group from day 4 to day 21. Time to semi-recovery in days, assessed by 50% of CSS, is better in Viusid-Asbrip group vs. Control group (6.07 ± 2.77 vs. 8.35 ± 2.94, p = 0.02). Time to recovery in days respectively is (14.05 ± 4.15 vs. 19.25 ± 2.12, p = 0.0001). And Hospitalization days are (9.05 ± 2.58 vs. 12.75 ± 4.44, p = 0.0003). <em>Conclusion</em>: This trial shows that adding of Viusid & Asbrip to the treatment of COVID-19 can contribute to faster recovery of the patients, decreasing of the hospital stay and milder course of the disease.
基金This work was supported in part by the National Natural Science Foundation of China(No.82174053)This research received a grant from Dalian Fusheng Pharmaceutical Co.,Ltd.(Liaoning province,China)。
文摘Objective Phillyrin(KD-1)is a traditional Chinese monomer and the main active component in Lianhua Qingwen.At present,sufficient studies have confirmed that KD-1 has significant anti-SARS-CoV-2 activity and antiinflammatory effects in vitro and in vivo.However,evidence-based studies to evaluate its therapeutic effect on COVID-19 are lacking.Therefore,we designed a clinical trial to evaluate the efficacy and safety of KD-1 in the treatment of moderate COVID-19 infection.Methods This is a multicenter,randomized,double-blind,placebo-controlled clinical trial.A total of 120 participants will be recruited and randomized to receive KD-1 capsule or placebo treatment for 14 days,50 mg per capsule,four capsules each time,three times a day.If the SARS-CoV-2 nucleic acid test results are negative twice within 14 days,the KD-1 capsule will be stopped the following day.Symptoms,patient compliance,and adverse reactions will be recorded,and nucleic acid testing will be conducted daily.Primary and secondary outcomes,as well as safety indicators,will be used to evaluate the efficacy and safety of the KD-1 capsule in the treatment of COVID-19.Discussion Herein,we describe the first clinical trial in China to treat COVID-19 using a traditional Chinese medicine monomer.A randomized,double-blind,placebo-controlled clinical trial is the best way to evaluate the efficacy and safety of KD-1 against moderate COVID-19 infection.If a good clinical benefit is observed,this represents the first step toward the use of KD-1 capsules to treat COVID-19.This clinical trial can serve as a model for other evidence-based research of traditional herbal medicines.Trial registration This study is registered at chinadrugtrials.org.cn,with registration number:CTR20211800.
文摘目的观察温针灸联合刺络拔罐治疗轻型新型冠状病毒(corona virus disease 2019,COVID-19)感染患者的临床疗效。方法将82例COVID-19轻型患者随机分为治疗组和对照组,每组41例。对照组予连花清瘟颗粒口服,治疗组在对照组基础上给予温针灸联合刺络拔罐治疗。比较两组退热时间,两组治疗前后咳嗽视觉模拟量表(visual analog scale,VAS)、中文版莱塞斯特咳嗽生命质量问卷(Mandarin Chinese version of the Leicester cough questionnaire,LCQ-MC)、咽干/痛缓解程度,并比较两组安全性情况,追踪观察两组患者是否出现“长新冠综合征”和COVID-19二次感染情况。结果两组退热时间比较差异有统计学意义(P<0.05)。两组治疗后咳嗽VAS评分低于治疗前,且治疗组低于对照组,差异有统计学意义(P<0.05)。两组治疗后LCQ-MC评分低于治疗前,且治疗组低于对照组,差异有统计学意义(P<0.05)。两组治疗后咽干/痛程度分布优于治疗前,且治疗组优于对照组,差异有统计学意义(P<0.05)。两组“长新冠综合征”发生率比较差异无统计学意义(P>0.05)。两组COVID-19二次感染率比较差异无统计学意义(P>0.05)。两组疗法安全性均可。结论在口服中成药的基础上,温针灸联合刺络拔罐治疗COVID-19轻型患者在急性期临床疗效显著,安全性高。
