The CRISIS2 Study: A phase 2, randomized, double blind, placebo-controlled, multi-center study assessing the safety and anti-coronavirus response of suppression of host nucleotide synthesis in out-patient adults with SARS-CoV-2

Date Added
November 17th, 2020
PRO Number
Pro00105979
Researcher
Eustace Riley

List of Studies

Keywords
Coronavirus
Summary

The CRISIS2 trial will study out-patients (non-hospitalized patients) who have a
positive SARS-CoV-2 test and are symptomatic. Subjects will be randomized to
receive standard of care (SOC) + 5 days of brequinar or SOC + 5 days of placebo.
The purpose of this study is to determine if the in vitro antiviral activity of
brequinar can be duplicated in patients infected with SARS-CoV-2 by measuring
the effect of brequinar on viral shedding. Importantly, the safety and tolerability of
brequinar will also be determined in these patients. The results of this proof-of concept study will inform future studies that will help determine if brequinar is a
safe and effective drug for the treatment of SARS-CoV-2 infection.

Institution
Self Regional
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org



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