Quote:The FDA in May okayed sales of remdesivir on an emergency basis for patients hospitalized with severe COVID-19, the disease caused by the new coronavirus, after trial data showed that the antiviral drug helped shorten their hospital recovery time. Company data published on Friday showed that a 5-day course of intravenous remdesivir modestly helped less severely ill COVID-19 patients, but a 10-day course did not show a benefit.
Leronlimab showed clinical and statistical improvements. At day 3 and day 14 per protocol population and at day 14 all treated as per NEWS2 .
Quote:Diana Brainard, head of clinical research at Gilead, also told Reuters that the company's formal FDA application for the drug, submitted earlier this month, seeks approval for use in all hospitalized patients with COVID-19.
So GILD is going to treat all conditions !!!, Mild, Moderate, Critical, Serious. The whole enchilada !!! and we, with statistical and clinical results don't get even an EUA.
Quote:The 600-patient analysis, published by the Journal of the American Medical Association, found that moderately ill patients treated with the antiviral drug for up to 5 days had significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, compared to patients given standard treatment.
This is exactly NEWS2 were we showed stellar results in spite of patients being "milder" than those of Remdesivir ("milder" patients are more difficult to show results on)
Leronlimab: we did only 84 patients, however: In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group. .
Quote:Brainard said the clinical importance of the benefit for those patients was uncertain, due to continued questions about how best to measure patient outcomes other than survival.
Really ??? What about the trial primary end point ??? Or Secondary end point ???. Does not matter ??? Uncertain after the trial??? Am I missing something ??? . Are you kidding me ?? Not certain how to mesure and yet ask and get approval???. Continued questions ??? What are trials for ??? Hint: To answer those questions !!!!
Differing trial results for remdesivir raise "the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped," according to a JAMA editorial accompanying the study.
Quote:The study in moderately ill COVID-19 patients showed that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital.
So they were hospitalized !!!. More "moderate" than ours …
Leronlimab: for moderate patients (TCCS>4) 90% on leronlimab arm vs. 71% on placebo at day 3 improved. The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
Leronlimam patients were more “difficult” apparently as they were NOT hospitalized. Remdesivir were. We obtained better (statistical) results with our more severe patients which, apparently were les severe than the Remdesivir ones (theirs were hospitalized)
The JAMA editorial said important questions remain regarding the efficacy of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the drug's impact on clinical outcomes, and its relative effect if combined with generic steroid treatments.
Yet, they are trying to get approval for all severities. and probably get it in spite of not being able to demonstrate anything. Where is the p-value ?? where are the primary and secondary outcome numbers ??? where are the STATISTICAL results for Pete's sake ??
And the tragedy is …. that they might get approval ….
What about us ???
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