Thank you for your interest in the PRINCIPLE Study.
The study stopped recruitment in July 2022, and we have been continuing to collect the data we need for the analysis of the Ivermectin and Favipiravir arms of the trial since this date. As a result, we have not yet published the results for these two treatments. Participants in the trial are followed up for a full year, so that we are able to answer the critically important questions about the effect of treating acute SARS-Cov-2 infection on symptoms and well-being over the longer term. We will be uniquely paced to provide data on possible impact on longer term symptoms.
The team are currently working hard on collecting the one year follow up data which should be complete by the end of July 2023. Once data collection is compete, queries still need to be made, and the data will still needs to be fully cleaned and the subject to complex analyses. We are committed to doing this in the most rigorous and transparent way according to our published protocol.
Please be assured that you will be able to find the results on this page as soon as they become available, and we will submit scientific papers describing this rigorous, independent evaluation of these medicines to peer reviewed journals as soon as possible.
Suspicious.
Budesonide appears to be working, based on an 'interim analysis'.
Early treatment with inhaled budesonide shortens recovery time by a median of three days in patients with COVID-19 who are at higher risk of more severe illness and are treated in the community. A common corticosteroid, budesonide is the first widely available, inexpensive drug found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home and in other community settings. The findings are based on an interim analysis, which included 751 people in the budesonide group and 1028 in the usual care group who were SARS-CoV-2 positive.
Participants in the trial are followed up for a full year
June 2021 the Ivermectin trial started, to last 14 months. Sounds like 2 months of trial and 12 months of follow-up, right? But they say it was always the plan during a pandemic to do a two year trial.
the one year follow up data which should be complete by the end of July 2023
That's June 2021 + 14 months + another 12 months.
At the time it was clear from hundreds of non-"gold standard" trials that ivermectin works better the sooner you get it, and best if taken before symptoms. But PRINCIPLE recruited people after official diagnosis (sick enough to go to the doctor). That and the stonewalling clearly indicate this was designed to fail.
Yet their protocol says they can announce failure from time to time and they haven't announced failure, so even trying to find nothing by giving ivermectin after diagnosis my guess is they still found some effectiveness. Probably some people did a home test, went to doctor, and got trial ivermectin early before symptoms so the overall data shows some effectiveness.
Right now I bet they're frantically trying to figure out how to group the data so that it only shows a weak result rather than an obvious truth. For example, if they grouped it by 0, 1, 2, .. days since symptoms it'll show huge effectiveness at 0 so they only break it down like 0-3 days since symptoms to water it down.
This is what the only other randomized, controlled study did; found some effectiveness, but not statistically relevant, in 0-3 days after hospitalization - which means well into the infection. What about day 0? We'll never see that data.
From the comment section, a link to the study's website:
Suspicious.
Budesonide appears to be working, based on an 'interim analysis'.
June 2021 the Ivermectin trial started, to last 14 months. Sounds like 2 months of trial and 12 months of follow-up, right? But they say it was always the plan during a pandemic to do a two year trial.
That's June 2021 + 14 months + another 12 months.
At the time it was clear from hundreds of non-"gold standard" trials that ivermectin works better the sooner you get it, and best if taken before symptoms. But PRINCIPLE recruited people after official diagnosis (sick enough to go to the doctor). That and the stonewalling clearly indicate this was designed to fail.
Yet their protocol says they can announce failure from time to time and they haven't announced failure, so even trying to find nothing by giving ivermectin after diagnosis my guess is they still found some effectiveness. Probably some people did a home test, went to doctor, and got trial ivermectin early before symptoms so the overall data shows some effectiveness.
Right now I bet they're frantically trying to figure out how to group the data so that it only shows a weak result rather than an obvious truth. For example, if they grouped it by 0, 1, 2, .. days since symptoms it'll show huge effectiveness at 0 so they only break it down like 0-3 days since symptoms to water it down.
This is what the only other randomized, controlled study did; found some effectiveness, but not statistically relevant, in 0-3 days after hospitalization - which means well into the infection. What about day 0? We'll never see that data.