The wording below is mostly quotes from the given sources but has a little paraphrasing.
https://www.nytimes.com/2022/03/30/health/covid-ivermectin-hospitalization.html
Together study in Brazil found ivermectin did not lower hospitalizations.
https://c19ivermectin.com/togetheri...r-for-plain-language-summary-writing-support/
Together study in Brazil
Did not exclude patients with recent ivermectin use. Ivermectin was available OTC, was recommended by the government for COVID-19, and had nine times higher sales
Treatment delay is currently unknown, however the protocol allows very late inclusion and a companion trial reported mostly late treatment.
Treatment was administered on an empty stomach, greatly reducing expected tissue concentration [Guzzo] and making the effective dose about 1/5th of current clinical practice.
Authors perform analysis excluding events very shortly after randomization for fluvoxamine but not ivermectin,
The control arm ran from Jan 20 to Aug 5, 2021, while ivermectin arm ran from March 23 to Aug 6, 2021. Treatment efficacy can vary significantly over time, for example due to overall improvement in protocols, changes in the distribution of variants, or changes in public awareness and treatment delays. Specifically, Gamma variant had dramatically higher mortality vs non-Gamma variants...
RCTs have a fundamental bias against finding an effect for interventions that are widely available — patients that believe they need treatment are more likely to decline participation and take the intervention i.e. RCTs are more likely to enroll low-risk participants that do not need treatment to recover (this does not apply to the typical pharmaceutical trial of a new drug that is otherwise unavailable). This trial was run in a community where ivermectin is widely known and used.
The trial is associated with:
MMS Holdings - a company whose mission includes helping pharmaceutical companies get approval and designing scientific studies that help them get approval. One of their clients is Pfizer [mmsholdings.com].
Cytel Inc. - another statistical modelling company that helps pharmaceutical companies get approval - they work very closely with Pfizer [cytel.com].
One of the senior investigators was Dr. Craig Rayner, President of Integrated Drug Development at Certara - another company with a similar mission to MMS Holdings. They state on their website that: "Since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA." One of their clients is Pfizer [certara.com].
The DSMB chair has published a paper with members of a well known anti-treatment research group [Thorlund].