I am not sure I understand why the FDA and NIAID are deciding its best to apply the breaks in order to study convalescent plasma instead of rolling it out to hospitals across the nation. It's been used for over a century and doctors and patients seem to swear by it. At worst it seems like it would do no-harm so why deny likely beneficial treatment so all the experts can study just to make sure. The way this is being handled lends credence to HCQ being torpedoed due to political reasons.

https://www.whio.com/news/trending/fda-puts-covid-19-blood-plasma-therapy-hold/A5YW6GGBZ5EDNDAMPY27YRQKNQ/

Per the Houston Chronicle, the doctors at Houston Methodist aren't happy because they have had success using the plasma to treat patients at it's Medical Center location. Apparently the experimental use was only allowed at teaching hospitals and Houston Methodist was having success and wanted to see it rolled out to the suburban locations outside of the Medical Center as well.

Makes me wonder if "other" hospitals were perhaps giving this plasma to patients who were too far along in this disease and had too many other complications. It seems obvious that plasma would most benefit patients early in the course of COVID who didn't have multiple significant complications.


https://www.houstonchronicle.com/news/health/article/uthealth-baylor-college-houston-covid-plasma-texas-15496877.php

Where is the data showing this treatment works?

I kind of assumed it would, but with what we know now about the weak B cell response in many patients I'm not so sure how helpful it would be.

Also, it's not a scalable solution anyway. IF passive immunity is the answer, then one of the antibodies cocktails will have to do it.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362821/

best study I could find. They acknowledge that the control group wasn't as sick, so that may be a point in the study's favor. Apparently another European study was stopped because all their admitted COVID patients already had high antibody titers at time of admission. So there wasn't any point in giving more.

I was a bit shocked that the FDA came down so hard on its use.

The FDA is in a tough spot since this has become so political. They rushed a lot of temporary approvals out in the spring and it really bit them in the ass with tests that were crap and drugs that didn't work.

So the easy option now is to go back to the high bar they had for approval in non pandemic times. They've actually dropped the hammer unexpectedly on a gene therapy for hemophilia and a potential arthritis blockbuster in the last week. So it's not just COVID-19 drugs having a hard time right now.

The Medcram Update #103 was released today and discusses this very topic.


As I suspected it looks like hospitals have been giving it to patients who are too far along (> 4 days from onset of symptoms) and then noting that its not helping a large enough percentage of these patients. However as expected, the patients who received the plasma in 3 or less days showed statistically significant improvement, thus meaning its validated for this group. Unfortunately when these 2 populations are combined, the results of the <3 day patients are watered down and the data no longer shows statistical significance. As a result the FDA raises red flags and informs the medical community to tap the breaks and is now requesting a another study with a control group.

Wow, I don't see how all of this isn't obvious to these eggheads! At worst convalescent plasma does no harm and has been shown to be beneficial when administered early. Do these guys chew on lead paint chips?