Let’s be quite clear here, there’s no miracle drug for all this. I am personally not enthusiastic about Remdesivir in Severe COVID-19. I personally have zero experience with Remdesivir at this point in time. Hopefully you all can comment on whether you anecdotally think it works or not. This study was published earlier today in the NEJM and is free for you to download and read for yourself. Do not trust me. This is not medical advice. This is industry sponsored but someone had to pay for the medication.
We’ve all been hearing about compassionate use but what does it mean? Well, it means that we can give an unapproved (by the FDA in the US) medication has the potential benefit to justify the risks of treatment. In this case, remdesivir has been pulled from the shelf to allow us to try to treat COVID-19 due to its in vitro activity against SARS-CoV-2. It also has numerous other applications that you can check out on your own.
n=53 (originally 61 but some couldn’t be analyzed) 75% were dudes. 57% on vent. 8% on ECMO.
Patients: sats < 94% on RA or need for O2. Also needed to have kidneys and a liver (that all worked). Symptoms started a median 12 days prior to starting treatment.
Dose: 200mg IV on day 1, 100mg IV on days 2-10.
What did they do?
They monitored the patients for at least 28 days and quantified events. No specified end points. It was a “let’s see what happens” study. Compassionate use, indeed. Patients were obviously not randomized. No control arm. Sigh.
What did they find?
68% had an improvement in their O2 support. 15% worsened. It’s not 100% but nothing is except death and taxes. Was this because of the medication? We do not know.
Pts on RA or low flow: 100% got better. either they were going to get better on their own or the medication helped.
NIV or HFNC: 71% got better. Again, either they were going to get better on their own or the medication helped.
13% of all patients died. 18% of the patients on vents died. 5% of the patients on NIV died. Are these numbers about what we’re seeing for patients who end up in our hospitals?
Did they cause harm?
60% had adverse effects but if you honestly look at these, I can’t say they’re necessarily the fault of the study drug. 23% had pyrexia (fever) well, duh. And we are seeing renal impairment, AKI, MODS, DVT, ARDS all because of cytokine release syndrome. Can’t blame this necessarily on remdesivir. Also, two patients had pneumothoraces. That’s definitely not the study drug.
Limitations:
The limitations are endless and listed thoroughly by the authors. I honestly don’t know what to do with this data. It’s not like the results are too good to be true. They’re just meh.
-EJ
Click here for breakdowns of other COVID-19 Articles.
Citation:
Grein J, Ohmagari N, Shin D, et al. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020;382(24):2327‐2336. doi:10.1056/NEJMoa2007016
Link to Article
Link to PDF
FDA definition of “compassionate use”
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