UCLA AIDS Prevention and Treatment Clinical Trials Unit

Project SummaryA novel pneumonia caused by a previously unknown betacoronavirus emerged in Wuhan, China, in December2019. The virus is closely related to the severe acute respiratory syndrome coronavirus (SARS CoV-1), whichled to an outbreak in 2003, and has been named SARS-CoV-2. The human disease caused by SARS-CoV-2 iscalled COVID-19.During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, onJanuary 5, 2020, there were 59 confirmed cases, 278 cases on January 20, 2118 cases on January 26, andmore than 80,000 cases and 2700 deaths as of February 25, 2020, according to various international healthreporting agencies. As a result, on January 30, 2020, the International Health Regulations EmergencyCommittee of the World Health Organization (WHO) declared the COVID-19 outbreak a Public HealthEmergency of International Concern. On January 31, 2020, the US Department of Health and Human Servicesdeclared a public health emergency in the United States. As of March 21, 2020, there are 297,090 cases ofCOVID-19, including 22,177 cases in the United States (US), resulting in a total of 12,755 deaths globally.Despite quarantine measures, SARS-CoV-2 continues to spread (1). Outbreak forecasting and modeling suggestthat these numbers will continue to rise (2).At present, there is no specific antiviral therapy for COVID-19. Few treatment studies have been conductedbecause most human CoV strains cause self-limited disease, and care is supportive. After SARS-CoV-1 wasidentified in 2002-2003 and caused a large global outbreak, there was an increased interest in the developmentof specific therapeutic agents. SARS-CoV-1 patients were treated with corticosteroids, type 1 IFN agents,convalescent plasma, ribavirin, and lopinavir or ritonavir; except for ribavirin, many of these agents have in vitropre-clinical data that support their efficacy (3-11). Since the SARS-CoV-1 outbreak in 2002-2003, newtherapeutic agents targeting viral entry proteins, proteases, polymerases, and methyltransferases have beentested; however, none of them has been shown to be efficacious in clinical trials (12-19). Recent press-releaseand non-peer reviewed information suggests potential efficacy for a subset of SARS-CoV-2 patients, but thisremains to be reviewed and presented in peer-reviewed formats with sufficient granularity to be clinicallyimpactful.Given the continued spread of and lack of specific antiviral therapy for SARS-CoV-2 infection, this project willsupport additional testing and research to identify persons with SARS-CoV-2, and support infrastructure toincrease testing and conduct research on SARS-CoV-2 therapeutics and prevention in a safe and innovativeenvironment.