ACTIV-6 Ivermectin trial approval in dispute

ACTIV-6 Ivermectin trial approval in dispute

ACTIV-6 is a clinical trial funded by the National Institutes of the Health (NIH). The purpose of the trial is the development of outpatient treatments for COVID-19:

“ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial.”

The trial has since been defined to study Ivermectin and stipulates that half of the volunteers receive no outpatient treatment for the disease. This is controversial given the evidence for the effectiveness of this medication.

The study lead, Susanna Naggie, stated earlier that the trial had received approval from the institutional review board (IRB) and when asked about the justification for the trial explained:

“…The IRB was comfortable with our summary of the evidence and stance that there has not been a definitive determination of the efficacy of ivermectin. Similarly, the NIH COVID Guideline recommendation is that there is insufficient evidence to recommend for or against ivermectin for COVID-19. There are a lot of interested sites. Thus I think there remains sufficient equipoise on this question.”

We are now reporting that approval for this trial is in dispute. The Duke University Health System (DUHS) IRB claims that regulatory and ethics review of the trial took place at WCG IRB. However, WCG IRB states that it is not able to locate this protocol. WCG IRB was given the title and name of the principal investigator of the protocol.

The DUHS IRB has not responded to whether it has seen the IRB application. Nor has it responded to a request to confirm that the IRB had received approval. Naggie had not responded to a request for an explanation for why the WCG IRB does not have her application.

Responses

  1. Agree with Blueroux. Will add, again, that reliance on placebo arms in trials is unethical and cruel when there’s a global pandemic. If you want to study untreated people, just look out your window.

    I’m not surprised that WCG IRB has misplaced the paperwork. They’ve got 550 Covid studies ongoing, plus all the other disease studies they support. And what kind of nonsense is it that no one else has a copy?

    So yeah, get on with it. This is just another delaying tactic from the government, because they want you to die. What other conclusion can be derived at this point?

  2. definitive proof ivermectin works better than any other drug, countless frauds from public health agencies like this one but now we got it and so does the judicial system…..jail for life for trying to kill countless people by these frauds.the indian doctor might be the first one followed by many other doctors in western countries

  3. More bs from the NIH and related “partners.” Get on with it. Ivermectin works, so just give it across the board like they’ve done in other countries with great success. Stop torturing your citizens, American apex predator “healthcare” agencies!