NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That video you shared is from 2020, more definitive recent research has concluded there is no benefit, across the board. Multiple science journal articles in the best journals in the world. That is just a video vlog, I know from a respected guy, he was just feeding people hope at the time when there were no other drugs to treat people. But it was a theory and hope, and the only drug some doctors had and they were willing to give people it especially since people were convinced, wrongly, that it was a miracle drug, and a cure and it and ivermectin might prevent infection even. Unfortunately, it became a flashpoint in the culture wars and doctors don't want to get involved in that, so many just followed along. Placebo effect is a real thing.

But the reality is, when you have a placebo arm and you give patients HCQ it has no improvement. Some studies say nothing negative, but that may have to do with how it was given. Other studies say that some patients did have negative effects.

No reliable trial ever showed that it was definitively efficacious and disqualifying every trial that did not prove a much hoped for result, for some random reason, every time, does not prove anything.

This is a nice, general, public interest story about the research and how we got here. I know you won't believe it because it is mainstream media.

https://www.usnews.com/news/health-news/articles/2022-04-19/why-cheap-older-drugs-that-might-fight-covid-never-get-out-of-the-lab



The Lancet, Published: March 31, 2022: https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00060-6/fulltext

Interpretation

In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting.

Many trials of hydroxychloroquine for SARS-CoV-2 were redundant and potentially unethical: an analysis of the NIH clinical trials registry, November 12, 2021, Journal of Clinical Epidemiology, https://www.jclinepi.com/article/S0895-4356(21)00362-0/fulltext

Results

Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10).
Conclusion

Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.

Same with Ivermectin, Effect of Early Treatment with Ivermectin among Patients with Covid-19, May 5, 2022 https://www.nejm.org/doi/full/10.1056/NEJMoa2115869

Discussion
We did not find a significantly or clinically meaningful lower risk of medical admission to a hospital or prolonged emergency department observation (primary composite outcome) with ivermectin administered for 3 days at a dose of 400 µg per kilogram per day than with placebo. We found no important effects of treatment with ivermectin on the secondary outcomes.
The evidence supporting the role of ivermectin in the treatment of Covid-19 is inconsistent. At least three meta-analyses of ivermectin trials have strongly indicated a treatment benefit, and others have concluded that there was no benefit.7,8,18-20 Although the number of included trials involving outpatients varies among the meta-analyses, the overall number of events that occurred in our trial is larger than the number of all the combined events in these meta-analyses. The results of this trial will, therefore, reduce the effect size of the meta-analyses that have indicated any benefits. In addition, a reported trial of ivermectin treatment for Covid-19 was suspected of malfeasance and was withdrawn from publication,9 and other trials have been weakened by concerns about quality.8 A large collaboration of clinical trialists working on ivermectin treatment for Covid-19 has conducted a meta-analysis of trials and has concluded that ivermectin did not offer a treatment benefit when trials that were considered to be of moderate or better quality were examined.6 The WHO has concluded, on the basis of results obtained before our trial, that there existed only very-low-certainty evidence regarding ivermectin and thus recommended against the use of ivermectin for the treatment of patients with Covid-19 outside the clinical trial setting.21 The findings in our trial are consistent with these conclusions.
Major strengths of our trial include the rapid recruitment and enrollment of high-risk patients. We enrolled only patients who had a confirmed diagnosis of Covid-19 and less than 7 days of symptoms, and we did not enroll asymptomatic SARS-CoV-2–positive persons. The primary outcome was a composite of hospitalization for adjudicated Covid-19 as well as retention in a Covid-19 emergency setting for physician observation for more than 6 hours. Patients in these settings would typically have been hospitalized but were prevented from doing so because of limited capacity in hospitals.
When we began this trial, we randomly assigned patients to receive a 1-day dose of ivermectin, as is most commonly used for the treatment of parasitic diseases. We responded to feedback from advocacy groups regarding this administration schedule and adapted the duration of ivermectin administration to 3 days at a relatively high dose as compared with most other trials of this drug. Ivermectin has been used off-label widely since the original in vitro study by Caly et al. describing ivermectin activity against SARS-CoV-2,22 and in Brazil, in particular, the use of ivermectin for the treatment of Covid-19 has been widely promoted. We ensured that trial participants did not have a history of ivermectin use for the treatment of Covid-19 by means of extensive screening of potential participants about this issue. Given the public interest in ivermectin and the support of its use by paramedical groups, we suspect that there will be additional criticism that our administration regimen was inadequate. Details of the pharmacologic rationale and mechanistic hypotheses for ivermectin use are provided in the Supplementary Appendix.
In this randomized trial, the administration of ivermectin did not result in a lower incidence of medical admission to a hospital or prolonged emergency department observation for Covid-19 among outpatients at high risk for serious illness.

European Respiratory Journal, European Respiratory Journal 2022, check the footnotes: https://erj.ersjournals.com/content/59/1/2102002

Hydroxychloroquine and azithromycin were among the most commonly used repurposed drugs in the COVID-19 pandemic. Triggered by optimistic pre-clinical and early clinical reports, and perhaps also by the fear of the unknown disease and eagerness of finding a cure, the use of hydroxychloroquine increased rapidly from March to April, 2020 [23]. Later, its use steeply decreased in May and June, 2020, as more clinical evidence was gradually released. The subsequent pre-clinical investigations also revealed that the anti-viral effect of hydroxychloroquine in monkey kidney cell lines (VeroE6, as reported earlier in [8]) does not translate into inhibition of viral replication in primary respiratory epithelium cells. Nor does it confer protection against SARS-CoV-2 infection in primate animal models [24, 25]. The discrepancy between in vivo and in vitro phenotype should have halted the push of hydroxychloroquine to human use for treatment of COVID-19, but it was too late, as many clinical trials had already been launched and emergency use been authorised.

BMJ, May 2020, https://www.bmj.com/content/369/bmj.m1849

Conclusions Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.