id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-263628-ac9gld5l	Sivapalan, Pradeesh	Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan	2020-10-20		.txt	text/plain	3487	205	52	The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease. The objective of this randomized, placebo-controlled, double-blinded multi-center trial is to investigate whether 15-day treatment with azithromycin and hydroxychloroquine added to standard of care can shorten hospitalization and reduce the risk of non-invasive ventilation, admittance to ICU, and death. The interim analysis will focus on reporting the following: selected baseline data (those readily available from the baseline data list below), primary outcome (in an O' Brien-Fleming Plot), and all-cause mortality at 30 days (chi-square or Fisher's exact test, whichever appropriate).	./cache/cord-263628-ac9gld5l.txt	./txt/cord-263628-ac9gld5l.txt