Emory-CDC Clinical Trials Unit-Supplement for COVID-19 testing Project Summary/Abstract The emerging COVID-19 pandemic, caused by the SARS-Co-V-2 coronavirus has already caused over 1.3 million infections and over 80,000 deaths in the US as of May 13, 2020 (1). In the absence of effective therapies or a vaccine, non-pharmacologic measures such as social distancing, face masks and lockdowns have been implemented for prevention of COVID-19 infection which has helped to decrease the spread. Additional critical measures to control the pandemic include identification and isolation of infected individuals and contact tracing which requires scaling up of testing for all people. As of May 13, 2020, the US has been able to perform ~ 9 million tests, or around 29,000 tests/million population. While this is a large number and, in fact, more tests performed than any other country in the world, it is still not sufficient. Several investigators suggest that 3 ? 4 million tests/week are needed in order to test ~ 1% of the US population. Atlanta, Georgia has not been spared by the COVID-19 pandemic. While these is no data available for City of Atlanta, the 5 counties that form the Atlanta metropolitan area (Fulton, DeKalb, Gwinnett, Clayton and Cobb) have reported 11,771 cases which represents 34% of the total cases reported in the State of Georgia (2). The characteristics and clinical outcomes of hospitalized patients with COVID-19 in Georgia have been recently described (3). Among 305 patients, the median age was 60 years with 29% of the patients under the age of 50. Also, 83% were African American and although co-morbid conditions such as diabetes, obesity and hypertension were common, 1 in 4 patients admitted did not have any high-risk conditions. In a study among COVID-19 patients in three hospitals where Emory University faculty provide medical care, 20 of 530 persons had HIV co-infection. Median age was 57 years, most had controlled HIV and comorbid condition such as hypertension and diabetes. The Emory-CDC HIV Clinical Trials Unit has two Clinical Research Sites in Atlanta, the Hope Clinic of the Emory Vaccine Center and the Ponce de Leon Clinic. Both sites offer great opportunities to expand testing, not only to their existing patient populations but also to the neighboring communities. In this application we propose to use the existing infrastructure for research and will add expanded facilities for COVID-19 testing. Since testing for COVID-19 must incorporate safety measures for the staff, we plan to develop expanded facilities including temporary tents to accommodate potential drive through scenarios, and/or a mobile health clinic.

Public Health Relevance

Emory-CDC Clinical Trials Unit/Supplement for COVID-19 testing Project Narrative This project is critical for mitigating the current COVID-19 pandemic by providing expanded testing for the SARS-CoV-2 virus. Increased testing will lead to the identification of infected individuals and facilitate contact tracing for quarantine and isolation. Testing will also lead to the identification of potential participants who may be interested in participating in COVID-19 research and contribute to the control of the pandemic.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
3UM1AI069418-14S1
Application #
10166198
Study Section
Program Officer
Pouliot, Eileen M
Project Start
2020-06-16
Project End
2020-11-30
Budget Start
2020-06-16
Budget End
2020-11-30
Support Year
14
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Emory University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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