Real-World Data on 10,000 Healthcare Workers to Inform COVID-19 Prevention Policies
PRINCETON, N.J.—2020 年 8 月 13 日. Certara®, the global leader in biosimulation, has launched an international registry of healthcare workers to collect information on risk factors for developing COVID-19 and the use of preventative therapies. The International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global) will enable prevention policies to be informed by real-world data collected from 10,000 healthcare workers in low- and middle- income countries. UNITY Global was funded by a grant from the COVID-19 Therapeutics Accelerator.
Healthcare workers on the frontlines of the COVID-19 outbreak response are at high risk of exposure due to the nature of their work. As the extent of this outbreak is changing daily, guidance and policies for protecting healthcare workers need to rapidly evolve.
“Healthcare workers have a high incidence of severe COVID-19 as they are repeatedly exposed to individuals infected with SARS-CoV-2,” said William F. Feehery, PhD, Certara’s chief executive officer. “Limited evidence exists on the effectiveness of the preventative measures and treatment regimens currently being used. Through the registry, we hope to provide meaningful data to inform decision making that will help protect healthcare workers worldwide battling COVID-19 on the frontlines.”
The primary objective of the registry is to assess the association between the use of preventive treatments and the occurrence of SARS-CoV-2 infection in healthcare workers caring for patients with COVID-19. The registry first launched in Pakistan on August 3rd and will enroll 10,000 healthcare workers. Additional countries preparing for launch of the registry include South Africa, Nigeria, Kenya, Uganda, Senegal, Zambia, and Zimbabwe.
The registry collects information on a weekly basis from enrollees across a 12-week period. Data collection includes medications being taken by healthcare workers, their level of exposure to COVID-19 patients, their health status, and other factors such as the use of personal protective equipment (PPE), which would likely mitigate their risk of SARS-CoV-2 infection. In addition, the registry will record SARS-CoV-2 antibody test results. Certara is using advanced statistical modeling approaches to characterize the influence of these key factors on the risk of SARS-CoV-2 infection among healthcare workers.
Craig Rayner, Pharm. D., president of integrated drug development at Certara and Roman Casciano, general manager of Certara’s evidence and access division are co-principal investigators of UNITY Global. “Our advanced modeling capabilities and technology enable us to quickly and efficiently interpret the incoming flow of data from the registry with the highest level of scientific rigor, which is needed now more than ever as COVID-19 continues to spread,” said Roman Casciano. “We are proud to be spearheading this effort to better understand how we should be protecting our healthcare workers during today’s global health crisis and for future outbreaks.”
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国 FDA が承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
About the COVID-19 Therapeutics Accelerator
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer term.