REDS-IV-P Joins RESPONSE to Support Surveillance of SARS-CoV-2

Laboratory
The RESPONSE study will help further our understanding of the spread of this infection in asymptomatic populations.

The National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study IV–Pediatric (REDS-IV-P) Data Coordinating Center (DCC) administered by Westat will support new research to further our understanding of viruses and their pathogenesis, particularly amidst the SARS-CoV-2 pandemic. This project, REDS Epidemiology, Surveillance, and Preparedness of the Novel SARS-CoV-2 Epidemic, is known as RESPONSE. The project is funded by the National Institute of Allergy and Infectious Diseases in collaboration with NHLBI of the National Institutes of Health (NIH). This is a 1-year project valued at $1.5 million.

The RESPONSE study will

  • Evaluate SARS-CoV-2 assays that could potentially be used to screen for the presence of the virus
  • Conduct serosurveys to study how many people have been exposed to the SARS-CoV-2 virus in outbreak regions and developed antibodies against it
  • Enroll COVID-19 positive subjects in a longitudinal cohort study to answer fundamental questions on the evolution of viremia and early immune response
  • Establish a sharable biorepository for future research

As part of the research team, Westat, as the REDS-IV-P DCC, will use its research data collection platform made up of a suite of tools to support enrollment, consent, online surveys, data entry forms, biospecimen management, scheduling, monitoring, reporting, and analysis. These tools allow for flexibility, responsiveness, and capacity with respect to the study protocols, and ensures high-quality data. Westat’s secure FISMA-compliant data center, operating 24/7, will host the platform.

Westat will provide quality control for all data and harmonize study data received from the research sites and the REDS-IV-P Center for Transfusion Laboratory Studies (Vitalant Research Institute, San Francisco, CA), as well as other potential collaborators or data sources. We will develop submission protocols, standardized data formats, and systems for routinely and securely transferring data to the DCC. Once received, the data will be tracked, cleaned, processed, and made available for reporting and analysis.

“This important study will answer key questions about how many people have evidence of having contracted SARS-CoV-2 and advance our understanding of the natural history and pathogenesis of this new virus,” said Sunitha Mathew, the REDS-IV-P project director and a Westat Associate Director for Public Health and Epidemiology.

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