Note: This thread is related to #Coronavirus #COVID19

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Natalie E. Dean, PhD+ Your Authors @nataliexdean Assistant Professor of Biostatistics at @UF specializing in emerging infectious diseases and vaccine study design. @HarvardBiostats PhD. Tweets my own. Jun. 03, 2020 1 min read + Your Authors

New placebo-control randomized trial of HCQ for post-exposure prophylaxis published in @NEJM. No evidence of a protective effect for preventing symptomatic infection. This is a useful study. Offering a few reactions. 1/7
 https://www.nejm.org/doi/full/10.1056/NEJMoa2016638 

The study design is notable. Individuals with a known household or occupational exposure were able to sign up remotely and study drug (HCQ regimen or placebo) was shipped to them overnight. This is a creative strategy to access a wider pool of participants. 2/7

But a challenge with this strategy was that the investigators did not have tight control over confirmatory testing. While the expectation was that testing would become more broadly available, it remained unfortunately limited even for participating healthcare workers. 3/7

The pre-specified primary endpoint was symptomatic illness confirmed by PCR or, if testing was unavailable, COVID-19 related symptoms. The key results table is shown. As a result of limited testing, only 20 out of 107 endpoints were laboratory-confirmed. 4/7

There was no difference across the two groups looking at the composite primary endpoint of confirmed or probable disease. There was also no difference looking just at PCR confirmed cases (second row), though there were relatively few of these. 5/7

The study was randomized, so there should be no big difference between the groups in terms of the symptoms-only (less objective) endpoint. But HCQ does have side effects. Patients were reasonably able to guess if they received HCQ or placebo, so who knows if that mattered. 6/7

My overall reaction - more useful evidence that HCQ is not effective, but I don't think this is the end of HCQ. The drug is cheap and available, so we want to be sure. I would still like to see results from other ongoing, larger pre- and post-exposure prophylaxis trials. 7/END


You can follow @nataliexdean.



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