Read on Twitter
Long awaiting #COLCORONA RCT now in #PrePrint:-4488 non-hospitalized pts with suspected #COVID19 randomized to #colchicine (0.5 mg BID x3)vs placebo
-1° outcome (composite death/hospitalization) was NOT significant
-interesting findings in subgroups
https://www.medrxiv.org/content/10.1101/2021.01.26.21250494v1
1/
They had a pragmatic inclusion criteria of pts w/ suspected (not proven) COVID19 infxn.
It’s reasonable to do both ITT analysis (negative for all endpoints) & a modified-ITT analysis for PCR+ pt (positive at reducing hospitalizations but negative for intubations & deaths).
2/
It’s reasonable to do both ITT analysis (negative for all endpoints) & a modified-ITT analysis for PCR+ pt (positive at reducing hospitalizations but negative for intubations & deaths).
2/
Not so reasonable is a press release claiming that in pts w/ COVID19, “colchicine reduced hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.”
Nope! Despite a 4000+ pt trial MV & deaths were not significant even in modified-ITT analysis.
3/
Nope! Despite a 4000+ pt trial MV & deaths were not significant even in modified-ITT analysis.3/
This kinda blatant overstatement in a press release could get a pharmaceutical company in hot water with the FDA (or with investors via the SEC).
The investigators should have toned down this press release a bit.
4/
The investigators should have toned down this press release a bit.
4/
