Thread by @AeschlimannJeff

New trial of #hydroxychloroquine for #COVID from China. First thoughts:
1- It's a preprint on medRxiv - this means it has yet to be evaluated by the medical community and the information presented may be erroneous (read with a shaker of salt nearby)

medrxiv.org/content/10.110…

2- That said, the research protocol was approved by proper Ethics Cmte at Renmin Hospital in Wuhan, research procedures follow Declaration of Helsinki & registered in Chinese Clinical Trial registry #hydrochloroquine #Covid_19

3- Randomized, double-blinded trial (nice!)

4- Added #hydrochloroquine (200mg 2x/day x 5days) to standard therapy (oxygen, antivirals, antibacterials, immunoglobulins +/- steroids)
5- Patients could not have severe/critical #Covid_19 infection; avg age was ~45y.o., even split M/F.

6- Patients had to have chest CT findings of pneumonia (even though "mild" #COVIDー19 infection)
7- Main outcomes: Time to Clinical Recovery (TTCR, mainly improvement in fevers and/or cough) & chest CT changes from Day 1 to Day 6
8- Results: 62 pts in trial

9- Most pts had fever +/- cough at start (~64% & 61%); TTCR was ~1 day shorter in #hydroxychlorquine tx group (~2 vs ~3 days, both listed as statistically significant differences)
10- 81% of HCQ+std tx group had improved pneumonia (on CT scan) vs. 55% of std tx....this was NOT

...statistically significant, though (P=0.25 & 0.30, by my Chi-square & Fisher's exact test computation)
11- No pts who received #hydroxycholoroquine progressed to severe illness vs. 4/31 of std tx...not stat significant, though approaching it (P=0.11 by my Fisher's exact test)

Study Critique:
1- No mention of a pre-study primary outcome, no mention of calc. a proper sample size based on a primary outcome.
2- TTCR was defined as "return of [normal] body temp & cough relief for >72h. But they only mention checking these data for the 6d tx period?

3- Unfortunately, they did not report follow-up PCR tests to see if virus was undetectable in any patients in either group (only clinical/radiographic outcomes)
4- I was a little skeptical of the "statistical significance of the ~1day shorter TTCRs for #Hydroxychloroquine so...

...I made up a hypothetical data set to approximate the mean +/- std dev reported in the study for the two study groups. I ran t-test and non-parametric tests (Mann-Whitney) and I got P values close to what the researchers reported. That was nice...
#COVID19 #Hydroxychloroquine

5- Dose of #Hydroxychloroquine was a bit lower than that used in other trials. Still "worked" tho

All things considered, a decent clinical study. It provides some evidence to support potential benefit in patients with non-severe #COVID19 infection. Have to start somewhere.