Akselrod, Hana

Chang, Aileen Y.

Dobbs, John

Joyce, Lauren

Poon, Adrienne N.

Rao, Sanjana

Saintilma, Bitana

Shakhtour, Leyn

Sidahmed, Alfateh

Singh, Ruben

Srinivasa, Nandan

Truong, Gavin

English

George Washington University: Health Sciences Research Commons (HSRC)

Optimizing The George Washington University COVID-19 Biorepository for Data and Specimen Collection for ResearchLauren Joyce, BS, MPH(c)1, Alfateh Sidahmed, MD2, Leyn Shakhtour, BS(c)1, Nandan Srinivasa, BA, MD(c)3, Bitana Saintilma, RN, BSN2, John Dobbs, BA,MD(c)3, Gavin Truong, MD,3 Sanjana Rao, BS, MD(c)3, Ruben Singh3, Aileen Y. Chang, MD4, MSPH, FACP, Hana Akselrod, MD, MPH,4 Adrienne N. Poon, MD, MPH, FACP41.Milken Institute School of Public Health; 2. GW Medical Faculty Associates; 3. School of Medicine and Health Sciences; The George Washington University; 4. Department of Medicine, The George Washington University, Washington, DCLearning ObjectivesReferencesLessons LearnedBackground and Purpose• First reported in December 2019, the novel coronavirus named(SARS-CoV-2), which causes the severe acute respiratorysyndrome known as COVID-19, has spread rapidly across the world.• SARS-CoV-2 RNA has been detected not only in the respiratorytract but also in blood, urine, and stool specimens.• In the greater Washington, DC region (DMV), which includes parts ofMaryland and Virginia and houses the nation’s capital, there havebeen 1,057,944 cases and 19,417 deaths reported since March 5and continues to grow.• We have established a prospective longitudinal cohort study ofpatients diagnosed with COVID-19 at the George WashingtonUniversity, in Washington, DC with plans for follow-up over thecourse of one year.Goal of the biorepository:• Collect both biospecimens and clinical data to promote scientificinquiry into the basic science, pathogenesis, and mechanisms of thevirus causing COVID-19Results• The creation and establishment of a COVID-19 biorepository will be a valuable resource for scientific investigators to study the pathogenesis and mechanisms of the SARS-CoV-2 virus in the acute phase and longitudinally in follow-up as well as in patients with post acute sequelae of COVID-19. • Willingness of communities of color to participate in this study and support better understanding of COVID-19 is invaluable towards the study of health disparities facing this community.• A strong participant education effort is important to coincide with this project, in particular, for how this contribution would support understanding of COVID-19, which has been a major motivational factor towards participation. • It is important to engage participants as stakeholders in the research process and develop processes to feedback results of the study to the community. • Study retention beyond acute enrollments has been a challenge, but instituting processes for improved communication including a variety of approaches from phone calls, messages, and e-mails, as well as incentives has helped improve retention. • Teamwork has been critical for making this bio-repository a success and has included collaboration across clinical, enrollment, abstraction, and laboratory teams as well as scientific investigators. • Establishing systems for coordination including through many team workers working virtually through the pandemic is important for a successful project. This includes establishing clear defined roles and virtual systems and databases that allow teams to work both on-site and remotely. 92 COVID-19 PCR positive participants have been enrolled since April 2020 and enrollment and data collection are ongoing. Healthy controls are also being enrolled as a comparison group and 13 have been enrolled so far. An overview of patient enrollment according to follow-up time period is shown in Table 1. The enrollment, follow-up, and data entry process is shown in Figure 2.  Given patient retention and data collection challenges exist, various approaches have been implemented to optimize data and specimen collection. Retention strategies have included:● Verification of multiple sources of contact information at baseline● Utilization of Cisco Jabber app technology to contact enrolled patients● The implementation of a COVID-19 biorepository email account to send scheduled reminder notifications to patients● Reimbursement by providing patients gift cards at follow-up visits● Scheduling future visits during baseline● Bolstering data collection through data extraction from electronic medical records• Describe the development of the GWU COVID-19 biorepository• Create a profile of patients enrolled during the acute phase• Explore the value of a COVID-19 biorepository in helping answer important epidemiological/scientific research questions• Discuss lessons learned in establishing the GWU COVID-19 BiorepositoryAcute Phase10 Weeks Post Acute6 Months Post Acute12 Months Post AcuteProject DescriptionParticipant Recruitment: Confirmed SARS-CoV-2 positive patientsidentified from chart review or physician referral are invited to participatethrough informed signed consent under an IRB approved protocol.Specimen Collections:• Nasopharyngeal or oropharyngeal swabs for RT-PCR• Serological tests from adult patients: 30mL in acute phase and 50mLin post-acute phase including those with post-acute sequelae• Urine studies• Rectal, vaginal, and penile swabs are collected to detect mucosalshedding at follow-up time pointsClinical Data:• Clinical interviews conducted by the research team• Chart abstractions performed• De-identified clinical data entered into a secure RedCap databaseFigure 1: COVID-19 Specimen Collection Time Points• Alcendor DJ. Racial Disparities-Associated COVID-19 Mortality among Minority Populations in the US. Journal of clinical medicine. 2020;9(8). Epub 2020/08/06. doi: 10.3390/jcm9082442. PubMed PMID: 32751633; PubMed Central PMCID: PMC7466083.• CDC (2020). Cases in US. Accessed Mar 25.• Tan et al (2020). Known coronavirus cases in DC, MD and VA. Washington Post. Accessed Mar 25.• CDC (2020). Healthcare professionals: FAQs and answers. Accessed Mar 22.• CDC (2020). Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). Accessed Mar 19.• Henry, B. M., de Oliveira, M. H. S., Benoit, S., Plebani, M., & Lippi, G. (2020). Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. [Meta-Analysis Review]. Clin Chem Lab Med, 58(7), 1021-1028. doi: 10.1515/cclm-2020-0369• Lazzerini M et al (2020). COVID-19 in Italy. Lancet Glob Health.• NIH (2020). Clinical Spectrum of SARS-CoV-2 Infection. Accessed Mar 25.• WHO (2020). Coronavirus disease (COVID-19) outbreak situation. Accessed Mar 25.Funding Support: The George Washington University Office of the Vice President For Research; and Clinical and Translational Science Institute at Children’s NationalFigure 2. Process overview of Biobank enrollment and data entry Enrolled at Baseline (1-11 Days)Enrolled at 10-weeksEnrolled at 6-monthsEnrolled at 12-monthsNumber of COVID-19 patients (N=92) 49 (53.3%) 19 (20.7%) 21 (22.8%) 3 (3.3%)Table 1. Number of COVID-19 Patients Enrolled at Various Timepoints 

Optimizing The George Washington University COVID-19 Biorepository for Data and Specimen Collection for Research

https://hsrc.himmelfarb.gwu.edu/cgi/viewcontent.cgi?article=1038&context=gw_research_showcase

Optimizing The George Washington University COVID-19 Biorepository for Data and Specimen Collection for Research

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