Rapid accrual of biospecimens from research subjects tested for COVID-19 is essential to support the urgent need to both precisely characterize the biology of SARS-CoV-2 and to develop models that predict clinical outcomes accurately and reliably. The most efficient method to approve such a process at NYULH was to amend an existing protocol: the UC. The vital benefits of the UC for an institutional research program include enhancing patient protections and amassing population-level data, as non-clinical staff obtain consent and participation in the UC is institution-wide and not disease-specific. Using similar mechanisms will foster robust COVID-19 research by increasing the number of patients with different socioeconomic statuses, ethnic backgrounds, and medical histories, which will subsequently provide more generalizable results. By modifying the UC protocol to adapt to the current crisis, we built on the existing infrastructure developed at NYULH to maximize patient accrual, eliminate human error, and enable real-time data tracking in order to bank essential biospecimens required to further our understanding of COVID-19 pathology.
The protocol for COVID-19 biospecimen collections for research at NYULH minimizes interruptions in the delivery of care, includes vital biosafety measures, and maximizes the research potential for banked COVID-19 biospecimens (Figure 1). NYULH saw its first confirmed case of COVID-19 on March 11, 2020. In accordance with national and international policies, the IRB approved a waiver of consent to permit COVID-19 biospecimen collection on March 28, 2020. Within the next three weeks, over 10,000 patients were tested across all NYULH locations. Of the first 11,120 patients accrued to the COVID-19 database, 4,267 (38.4%) tested positive and approximately 10% required hospitalization. As of April 18, 2020, we successfully collected leftover nasopharyngeal fluid from all 11,120 patients tested, and baseline and longitudinal biospecimens from 1,000 hospitalized patients. By granting fast and safe collection, our timeline fosters clinical innovation that addresses the current crisis and promotes translational innovation that exploits the virus’s biology in unpredictable ways.
Centralizing governance and processing of the human samples under the CBRD also reduces exposure risk and expedites scientific progress. We therefore suggest establishing a main biorepository with institutional governance for all patients tested for COVID-19. Most importantly, this approach reduces potential exposure by diminishing transfer of biohazardous materials, limiting the number of additional specimens needed for collection, and adhering to biosafety guidelines. Further, it creates the potential to generate a holistic, statistically powered, and standardized cohort characterization by compiling all results in one bank, and it fosters important long-term follow up by overcoming the well-documented issues with decentralized biobank sustainability6-14. The creation of this resource at NYULH has enriched the community with high-quality patient-linked COVID-19 specimens, which has already contributed to novel findings about SARS-CoV-2 epidemiology3.
Our amended UC protocol actively supports studies of the New York outbreak in real time and critical research to combat the pathology of COVID-19. Over the past 4 weeks, viral RNA has been extracted from 236 samples collected in this pipeline, enabling a large ongoing sequencing project that provides valuable information about the source of infections and asymptomatic spread. New sequences are continuously uploaded in the GISAID EpiCov repository (www.gisaid.org) as they are analyzed. This biobank pipeline also provides the necessary resources to support the clinical laboratory in the current validation of ELISA assay for antibody detection with the collection of leftover whole blood and sera from COVID-19 patients.
Biospecimen research at NYULH is continuously evolving to address the health needs of the global population that it serves. In this critical moment, we provide vital resources and recommendations for the current crisis, founded on evidence-based protocols that we amended to overcome issues faced in the heart of the global pandemic. As we continue to reveal critical findings on the recent SARS-CoV-2 outbreak, we hope to invoke a worldwide effort to build up the resources needed to eradicate COVID-19 collectively, and serve as a reminder that resilience requires adaptability even in the face of the most challenging circumstances.