Remdisivir compassionate usage trial..

1,910 Views | 6 Replies | Last: 5 yr ago by Infection_Ag11
Marcus Aurelius
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AG
https://www.nejm.org/doi/full/10.1056/NEJMoa2007016?query=featured_coronavirus

NSIAP.

Observational study with hospitalized COVID-19 pts requiring supplemental O2. 61 pts given the anti viral remdisivir.

"Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation."

Some context. In the Wuhan NEJM observational study overall mortality for COVID-19 admitted pts was 22% and 68% for those requiring intubation. So certainly promising.
Dr. Not Yet Dr. Ag
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This study is currently getting absolutely shredded on social media sites by physicians. They excluded patients that died in the first 24 hours introducing survivorship bias. It has no control group. They somehow lost 8 patients to follow up with a study of only 61 patients. They excluded patients that had an ALT > 5x normal values, GFR<30, and if they were on pressors. They also do not indicate how patients were selected for inclusion for the study. This is basically just an ad for Gilead, and it is amazing that NEJM would actually publish this.

EDIT: Also, 9 patients remained intubated at the end of the follow-up period.
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Marcus Aurelius
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AG
Don't disagree. Take it FWIW.
VKint
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AG
Not much better than the flawed French HCQ study. I am strictly outpt now so not involved with critical care like you guys are. Any of you seen usage of remdesivir + tocilizumab? different mode of action. I assume there are ongoing trials.
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Marcus Aurelius
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AG
I suspect this combo will be the preferred treatment once the dust settles.
Zobel
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This one is interesting.

https://www.biorxiv.org/content/10.1101/2020.04.03.024257v1.full.pdf


Quote:

The efficacy of aprotinin and of remdesivir (currently under clinical investigation against SARS-CoV-2) were further enhanced by therapeutic concentrations of the proton pump inhibitor omeprazole (aprotinin 2.7-fold, remdesivir 10-fold)
cone
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AG
if this is all gilead has to show so far, welp that sucks
Infection_Ag11
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Study isn't clinically useful without a control group, especially given they excluded all the patients who died too quickly after administration.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
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