Thread by @AliNouriPhD

1st completed Randomized Clinical Trial for Convalescent Plasma finds NO IMPROVEMENT in mortality or progression to severe disease. Preprint: bit.ly/3iE1Qnd

You'll recall after pressure from President, FDA authorized the therapy in August: bit.ly/3c5sHGp 🧵 1/6

During that announcement the President, Sec. Azar & Commissioner Hahn all falsely claimed the therapy reduces mortality by 35%. Hahn later retracted.

Azar: "We dream in drug development of something like a 35% mortality reduction" 2/6

nytimes.com/2020/08/24/hea….

FDA authorization was based on a NON-randomized Mayo study that showed some improvement.

But the new study out of India, the first completed randomized trial, found no mortality reduction. Separately, a randomized Netherlands study was discontinued, having found no benefit. 3/6

The Netherlands study found no benefit in mortality, hospital stay, or disease severity and concluded "Most COVID-19 patients already have high neutralizing antibody titers at hospital admission" 4/6
medrxiv.org/content/10.110…

Lack of randomized data is why in August NIH's Fauci/Collins/Lane halted FDA authorization before the President stepped in to reverse it. “Three of us are pretty aligned on the importance of robust data through randomized control trials" -Dr. Lane 5/6
nytimes.com/2020/08/19/us/…

Still, some hope Plasma will yield benefit. Indian Trial administered it 8 days post-symptom onset. Giving it earlier from donors w/high titer may help. Also, there was improvement in viral clearing

But this highlights importance of randomized trials 6/6
the-scientist.com/news-opinion/i…