有几个trial显示“completed”，没看到结果，只有trial 本身的描述。请问这个“completed” 是说trial 已经将完成结果已经有了吗？还是说只是完成了吃药但病人的症状效果还没跟踪完？ 比如Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19Ivermectin for Severe COVID-19 Management Ivermectin Treatment Efficacy in Covid-19 High Risk Patients https://www.clinicaltrials.gov/ct2/results?cond=COVID-19&term=ivermectin&cntry=&state=&city=&dist=&Search=Search
感谢内行人。 这里结果看起来很好啊，那怎样的程序才能通过FDA approval 治疗covid呢？还是不需要approval 只靠医生开药就可以？ Covid Analysis (Preprint) (meta analysis)Ivermectin for COVID-19: real-time meta analysis of 67 studies • Statistically significant improvements are seen for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance. All remain statistically significant after exclusions. 45 studies show statistically significant improvements in isolation (35 primary outcome, 32 most serious outcome). • Meta analysis using the most serious outcome reported shows 67% [53‑76%] and 85% [75‑91%] improvement for early treatment and prophylaxis, with similar results after exclusion based sensitivity analysis (which excludes all of the GMK/BBC team studies), with primary outcomes, and after restriction to peer-reviewed studies or Randomized Controlled Trials. • Results are very robust — in worst case exclusion sensitivity analysis 56 of 67 studies must be excluded to avoid finding statistically significant efficacy.• While many treatments have some level of efficacy, they do not replace vaccines and other measures to avoid infection. Only 24% of ivermectin studies show zero events in the treatment arm. • Multiple treatments are typically used in combination, which may be significantly more effective. • Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all variants. All practical, effective, and safe means should be used, including treatments, as supported by Pfizer [Pfizer, TrialSiteNews]. Denying the efficacy of treatments increases the risk of COVID-19 becoming endemic; and increases mortality, morbidity, and collateral damage.
回复 3楼Inferno的帖子 问FDA Approval 是看到FDA网站说不建议用这个药的原因是没有临床试验和批准。那现在的trial data 够吗怎样才能获得批准呢？如果这个药很便宜，显然送交审批的incentive会比回报高的新药和疫苗少很多。 https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea. Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
https://www.clinicaltrials.gov/ct2/results?cond=COVID-19&term=ivermectin&cntry=&state=&city=&dist=&Search=Search
这个clinicaltrials.gov网站主要的目的是征召志愿者，尤其是一些稀少的病例要向全世界征召。试验结果不一定需要在clinicaltrials.gov上公布。你可以到下面这个网站去看各家的试验结果: https://c19ivermectin.com/
感谢内行人。 这里结果看起来很好啊，那怎样的程序才能通过FDA approval 治疗covid呢？还是不需要approval 只靠医生开药就可以？
Covid Analysis (Preprint) (meta analysis)Ivermectin for COVID-19: real-time meta analysis of 67 studies • Statistically significant improvements are seen for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance. All remain statistically significant after exclusions. 45 studies show statistically significant improvements in isolation (35 primary outcome, 32 most serious outcome). • Meta analysis using the most serious outcome reported shows 67% [53‑76%] and 85% [75‑91%] improvement for early treatment and prophylaxis, with similar results after exclusion based sensitivity analysis (which excludes all of the GMK/BBC team studies), with primary outcomes, and after restriction to peer-reviewed studies or Randomized Controlled Trials. • Results are very robust — in worst case exclusion sensitivity analysis 56 of 67 studies must be excluded to avoid finding statistically significant efficacy.• While many treatments have some level of efficacy, they do not replace vaccines and other measures to avoid infection. Only 24% of ivermectin studies show zero events in the treatment arm. • Multiple treatments are typically used in combination, which may be significantly more effective. • Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all variants. All practical, effective, and safe means should be used, including treatments, as supported by Pfizer [Pfizer, TrialSiteNews]. Denying the efficacy of treatments increases the risk of COVID-19 becoming endemic; and increases mortality, morbidity, and collateral damage.
问FDA Approval 是看到FDA网站说不建议用这个药的原因是没有临床试验和批准。那现在的trial data 够吗怎样才能获得批准呢？如果这个药很便宜，显然送交审批的incentive会比回报高的新药和疫苗少很多。 https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea. Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.