id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-258681-66ct8nod	Warnock, David G.	Clinical Trials during the SARS-CoV-2 Pandemic	2020-04-14		.txt	text/plain	731	43	52	The primary outcome measures of this trial include the incidence of active COVID-19-related disease at 14 days post-enrollment, and a COVID-19 Disease Severity Scale self-reported by participants at 14 days post-enrollment: no COVID-19-related disease (score of 1); COVID-19-related disease with no hospitalization (score of 2); or COVID-19-related disease with hospitalization or death (score of 3).The goal is to enroll and randomize 1,500 subjects into each of the active-drug and placebo arms, followed by a 6-day treatment course with hydroxychloroquine. Secondary outcome measures include 14-day incidence of hospitalization, 14-day incidence of confirmed SARS-CoV-2 infection, the number of participants in each arm who discontinue or withdraw from the protocol, and 90-day incidence of death related to COVID-19-related disease. The trial includes a chartered Data Safety Monitoring Board with defined stopping rules for clinical futility or statistically significant improvement in the primary outcome measures comparing the active-drug group to the placebo group (personal communication, March 22, 2020: covid19faq COVID-1-Post-Exposure Prophylaxis FAQ Account).	./cache/cord-258681-66ct8nod.txt	./txt/cord-258681-66ct8nod.txt