Stanford’s Clinical and Translational Research Unit (CTRU) is providing significant expanded support services (enrollment, laboratory, and clinical) for the NIH RECOVER study: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults. The overarching goals of the study are to define the epidemiology and pathophysiology of Long COVID, and to identify therapies to mitigate patient symptoms.
One of 15 hubs across the country to have enrolled adult participants, Stanford has the highest enrollment for the study (more than 1,000: 100% of target enrollment), with 69 of those enrollees coming from the Tri-Valley location (111% of target enrollment). Approximately 50% of enrollees are from groups underrepresented in biomedical research.
“We have had strong and consistent enrollment since our efforts began in late 2021,” stated CTRU Director Amrita Herkal. “In particular, we have focused on enrolling acutely infected participants as prioritized by the study.”
Funded by Stanford’s CTSA, the CTRU laboratory has played a vital role in all aspects of biospecimen processing for RECOVER, including rapid implementation of a complex protocol in late 2021 and implementation of local processing (to increase sample quality) in June 2022, as well as receiving, processing, and shipping more than 48,000 specimens. The lab is also cataloging and capturing specimen data essential to downstream research—including blood collections for genomic analysis—and processing nasopharyngeal swabs, serum, plasma, urine, stool, and saliva.
“The CTRU team’s biospecimen processing expertise has been crucial in preparing samples for future analyses,” explained Upinder Singh, M.D., professor of infectious diseases and geographical medicine and of microbiology and immunology at Stanford. “Their work is essential to the efforts of RECOVER to identify a biomarker for Long-COVID.”
The CTRU clinic core also supported the RECOVER study by performing assessments such as phlebotomy and comprehensive sample collection, orthostatic vital signs, 30 second sit-to-stand testing, oral glucose tolerance testing, ECGs, and 6 minute walk testing.
“The CTRU team is very motivated to move biomedical research forward,” said Dr. Singh. “Patients talk about the caring, positive interactions with the clinical team. This patient-first approach is crucial to the success of clinical trials and we’re grateful to the CTRU team for their collaboration.”
“We are tremendously appreciative of the contributions the entire CTRU team made to the NIH RECOVER study,” stated Senior Associate Dean of Research Ruth O’Hara, Ph.D. “Their dedication to this project is making a true difference in Long COVID research.”
Housed in Stanford’s Freidenrich Center for Translational Research, the CTRU is the institution’s largest research-focused, ambulatory care and laboratory care group offering both adult and pediatric bedside care, phlebotomy, dietary, and laboratory services across the research community. The CTRU clinical team consists of highly specialized research nurses and other medical professionals to support multi-disciplinary human subject trials. CTRU laboratory personnel are set up to handle high-volume, longitudinal studies and disease registries that require advanced isolation and distribution of various biofluid and tissue specimens.
Read more about the NIH RECOVER study here: https://recovercovid.org/
More information about the Stanford CTRU is available here:
https://med.stanford.edu/ctru.html
