"When it comes to critical patients, the go-to treatment still in development has to be CytoDyn’s leronlimab, which is under controversy due to clinical trial design struggles. The drug is a monoclonal antibody but it works differently than the monoclonal antibodies that go after the virus. Leronlimab is a subcutaneous shot that targets the pathological trafficking of certain immune cells and helps quickly bring the body into immune homeostasis and out of the cytokine storm state. This easy-to-administer subcutaneous shot showed an 82% decrease in mortality at 14 days post-treatment. Despite these tremendous clinical trial results, the trial design was botched and the DSMC failed to recommend changing the endpoints before the readout or changing the dosing schedule to continue dosing patients to keep their immune systems in check. Notice in the chart (earlier in this article) how the drug worked while the patient was on it (approximately up to day 14) but withdrawing an additional two weeks of dosing, the trial design and lack of follow-up dosing allowed patients to regress and die instead of being extubated and recovering. It appears that the FDA’s hands were tied and they wanted more data. Right now the company is in phase 3 clinical trials in Brazil, recruiting patients in a critical trial. Since the company achieved statistical significance at relevant points in the prior “botched” trial, this new Brazilian phase 3 trial is designed to check the right boxes with better dosing and measurements. It’s no mystery to those who follow leronlimab that this drug works. The only mystery is why no one in the United States can access the drug through compassionate use. Unfortunately, the FDA seems to have shut down that program given the overwhelming demand."
https://seekingalpha.com/amp/article/4467122-...lnupiravir
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