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.