Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform.



The SARS CoV-2 virus has caused one of the deadliest pandemics in recent history, resulting in over 170 million deaths and global economic disruption. There remains an urgent need for clinical trials to test therapies for treatment and prevention.


An online research platform was created to support a registry community of healthcare workers (HCWs) to understand their experiences and conduct clinical studies to address their concerns. The first study, HERO-HCQ, was a double-blind, multicenter, randomized, pragmatic trial to evaluate the superiority of hydroxychloroquine (HCQ) vs placebo for pre-exposure prophylaxis (PrEP) of COVID-19 clinical infection in HCWs. Secondary objectives were to assess the efficacy of HCQ in preventing viral shedding of COVID-19 among HCWs and to assess the safety and tolerability of HCQ.


HCWs joined the Registry and were pre-screened for trial interest and eligibility. Trial participants were randomized 1:1 to receive HCQ or placebo. On-site baseline assessment included a COVID-19 nasopharyngeal PCR and blood serology test. Weekly follow-up was done via an online portal and included screening for symptoms of COVID-19, self-reported testing, adverse events, and quality of life assessments. The on-site visit was repeated at Day 30.


The HERO research platform offers an approach to rapidly engage, screen, invite and enroll into clinical studies using a novel participant-facing online portal interface and remote data collection, enabling limited onsite procedures for conduct of a pragmatic clinical trial. This platform may be an example for future clinical trials of common conditions to enable more rapid evidence generation.





Published Version (Please cite this version)


Publication Info

Friedland, Anne, Adrian F Hernandez, Kevin J Anstrom, Mei Lin Chen-Lim, Lauren W Cohen, Judith S Currier, Christopher B Forrest, Ryan Fraser, et al. (2021). Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform. Contemporary clinical trials, 109. p. 106525. 10.1016/j.cct.2021.106525 Retrieved from

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Brian McCourt

Senior Dir, IT

Emily O'Brien

Associate Professor in Population Health Sciences

Dr. Emily O’Brien is Associate Professor in Population Health Sciences, Associate Professor in Neurology, Core Faculty Member at Duke-Margolis Center for Health Policy,  and Co-Director of Population Health Sciences at the Duke Clinical Research Institute. Her research focuses on comparative effectiveness, patient-centered outcomes, and pragmatic health systems research in cardiovascular and pulmonary disease. Her areas of expertise include: Epidemiology, Pragmatic Clinical Trials, and Clinical Decision Sciences. Dr. O’Brien received her PhD in Epidemiology from the University of North Carolina in Chapel Hill. As principal investigator for projects funded by the FDA, NIH, and PCORI, she has extensive experience working with diverse data sources including registries, epidemiologic cohorts, electronic health records, and administrative claims data. Dr. O’Brien teaches Analytic Methods in the Department of Population Health Sciences PhD program and has co-authored over 160 manuscripts in peer-reviewed journals on topics ranging from epidemiologic methods, comparative effectiveness, and pragmatic clinical trials. She is an associate editor for Circulation: Cardiovascular Quality and Outcomes, Chair of the AHA QCOR Scientific & Clinical Education Lifelong Learning Committee, social media editor for the Journal of the American Heart Association, and a fellow of the American Heart Association.


Christopher Wildrick Woods

Wolfgang Joklik Distinguished Professor of Global Health

1. Emerging Infections
2. Global Health
3. Epidemiology of infectious diseases
4. Clinical microbiology and diagnostics
5. Bioterrorism Preparedness
6. Surveillance for communicable diseases
7. Antimicrobial resistance


Susanna Naggie

Professor of Medicine

Dr. Susanna Naggie completed her undergraduate degrees in chemical engineering and biochemistry at the University of Maryland, College Park, and her medical education at Johns Hopkins School of Medicine. She conducted her internal medicine and infectious diseases fellowship training at Duke University Medical Center, where she also served as Chief Resident. She joined the faculty in the Duke School of Medicine in 2009. She is a Professor of Medicine and currently holds appointments at the Duke University School of Medicine, at the Duke Clinical Research Institute, and at the Durham Veterans Affairs Medical Center. Dr. Naggie is a clinical investigator with a focus in clinical trials in infectious diseases and translational research in HIV and liver disease. She is a standing member of the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents and the CDC/NIH/IDSA-HIVMA Opportunistic Infections Guideline. She is the Vice Dean for Clinical and Translational Research and Director for the Duke Clinical and Translational Sciences Institute.

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