Key Points About BU CTSI Responsiveness & Accomplishments
In response to the COVID-19 pandemic, the BU CTSI prioritized the development and implementation of high-quality translational research. In order to mitigate the public health crisis, we have strengthened research infrastructure, resources, services, expertise, tools, and partnerships. Specifically, The BU CTSI accomplished the following:
- Catalyzed data collection and sharing among investigators by supporting the establishment of an EMR-based database that uses pre-COVID clinical informatics infrastructure and platforms to monitor health-related information on COVID-19 patients.
- Provided rapid turn-around pilot funding totaling $431,562 for 21 COVID-19 research projects that span the translational continuum, including areas from basic virology, creation of novel mouse models, 3D synthesis of PPE, and clinical studies of COVID outcomes.
- Empowered investigative teams to quickly set up new operational workflows, remove traditional roadblocks, and complete the required regulatory policies and procedures to launch clinical trials.
- Supported the continuation of existing studies and the implementation of new COVID-19 related studies at the GCRU.
NCATS’ Response to COVID & the BU CTSI’s Contributions
- Researchers studying COVID-19 now are able to access an innovative new analytics platform, part of the NCATS National COVID Cohort Collaborative (N3C), that contains clinical data from the electronic health records of people tested for the novel corona-virus or who had related symptoms.
- Created through a collaboration between the U.S. Food and Drug Administration (FDA) and NCATS, CURE ID enables the crowdsourcing of medical information from health care professionals to facilitate the development of new treatments using repurposed drugs for difficult-to-treat infectious diseases.
- When the COVID-19 pandemic began, no approved therapeutics or vaccines were available to counteract SARS-CoV-2. NIH responded swiftly with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership to coordinate the development of the most promising treatments and vaccines. Alongside industry partners, NCATS has a lead role in a range of ACTIV efforts.
- As the COVID-19 pandemic rapidly evolved and underscored the urgency to get trials underway faster, NCATS’ Trial Innovation Network (TIN) and CTSA Program hubs stepped up to ensure effective support and rapid implementation of clinical research studies aimed to treat or understand various aspects of COVID-19.
- Collaboration with the Rapid Acceleration of Diagnostics (RADxSM) initiative: Launched on April 29, 2020, to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, the initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations, and RADx Radical. It leverages the existing NIH Point-of-Care Technology Research Network and partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and the U.S. Food and Drug Administration. Learn more about the RADx initiative.
For More information about the NCATS Response to COVID go here
Preliminary Results of COVID-19 Related Research Projects
COVID-19 in Pregnant Women and in Their Infants
A CTSI grant catalyzed the launch of the perinatal COVID-19 research program. Led by Drs. Elizabeth Barnett and Elisha Wachman, the overall goal for this research is to gain a better understanding of the array of clinical manifestations of COVID-19 in mother-infant dyads and the extent that transmission occurs horizontally or vertically in order to develop best practice recommendations.
Their research includes both retrospective and studies. There is a retrospective review of 36 SARS-CoV-2 positive symptomatic COVID-19 pregnant women who delivered at Boston Medical Center between March and mid-June 2020. Preliminary data revealed, (1) 88% were under-represented minority women, (2) 19% had hypertension, (3) 37% had pre-pregnancy obesity, (4) almost 50% delivered by cesarean section, (5) the preterm delivery rate was 15.4%, and (6) 14% of the newborns had positive PCR testing for SARS-CoV-2.
In July 2020, a prospective cohort of COVID-19 mother-infant dyads was created from which biological samples (maternal blood, infant blood, cord blood, placental, infant urine, infant rectal swab, and breast milk samples), clinical data, and maternal questionnaire data were collected and analyzed.
Within few months of the CTSI award, the investigators published a paper on more than 60 placental samples from the cohort of COVID-19 positive women. A second manuscript on preliminary findings from the retrospective review is under review. These critical preliminary data are being leveraged to apply for larger grants to support the perinatal COVID-19 research program.
Sneckie PPE: Quick Dry Masks for the Homeless
This research proposes to test and rate the protection level of commercially available facemasks that resist moisture, dry quickly, and restrict permeability, to assist homeless populations from contracting COVID-19.
Led by Drs. Joyce Wong and Joshua Barocas, the team is working on a device that will be able to measure how porous different materials are under different simulated conditions. After that, we will be able to determine the type of material that might work best for this particularly vulnerable population.
Impact of Covid-19 on Vulnerable Families
This proposal brings together researchers from Boston Medical Center’s Department of Pediatrics to address the evidence gap regarding the specific mechanisms through which the COVID-19 pandemic is affecting low- income families with young children. Led by Dr. Emily Feinberg, the overarching goal is to efficiently provide empirical data that can be used to target programmatic and policy initiatives to support family well-being and resilience. By enrolling families of children with development and psychosocial risk from past and ongoing studies, the investigators have started interviews and are in a unique position to identify a diverse sample of families likely to be highly impacted by the pandemic and monitor them over time. Although findings have not been analyzed, common themes have been noticed: insufficient food or healthy food; increased conflicts between children in the home and between parents and children; feeling that telehealth visits are not comparable to in-person visits, despite being comfortable speaking with the provider during the visit.
See COVID-19 Related Research Awards and learn how the CTSI has been Helping investigators to expedite clinical and translational research and discovery related to COVID-19 specific challenges.
CTSI Informatics Supporting COVID-19 Research
The National COVID Cohort Collaborative (N3C)
This is an open science community that focuses on analyzing that aims to reveal patterns in COVID-19 and unify large amounts of data required for innovative machine learning and statistical analysis. The goal is to enable rapid collaboration among clinicians, researchers, and data scientists in order to identify treatments, provide specialized care, and reduce the overall severity of COVID-19.
Local Resources & Research Networks
Our foundational systems have provided a vital research resource during the COVID pandemic, as evidenced by two projects led by BMC/BUMC researchers.
COVID-Related Data Science
The Virtual COVID Repository was developed by Dr. Heather Hsu from BMC-CDW and colleagues from the BMC ACO Population Health Research Team. The goal is to accelerate the pace of COVID-19 research at BU and BMC and access to clinical data.
The team established a framework that uses standardized data queries and approaches and provides expertise and support. Drs. Hsu and Adams were also awarded an NCATS supplement to include Boston HealthNet CHCs and lead efforts to include data related to social determinants of health in the N3C dataset.
Led by Ioannis Paschalidis, PhD from the BU Center for Information and Systems Engineering program, a second project titled “Predictive Models of COVID-19 Outcomes” seeks to identify the key variables for COVID outcomes to predict patient: (i) hospitalizations; (ii) need for ICU treatment; (iii) need for intubation; and (iv) mortality. The goal is to develop personalized prescriptive models to make treatment recommendations from among the variety of emerging therapies, including several antiviral and immuno-suppressant medications.
The SCCM Discovery VIRUS Registry
VIRUS COVID-19 Registry was created in March 2020 to provide near real-time, detailed data regarding hospitalized and critically ill patients with C-19. As of August 07, 2020, we have enrolled more than 16,000 patients across 244 hospitals in 22 countries with daily medication, laboratory, vital sign, and healthcare outcomes in order to inform a wide range of research questions.
The data from the VIRUS registry displays real-time outcome information for patients with COVID-19 on the data dashboard https://sccmcovid19.org/ and currently serves as a source for more than 40 research studies.
Further work includes refining processes to validate automated data collection from electronic health records at scale. This facilitates accurate data collection for discovery regarding future pandemic and rapid healthcare response needs. Find more information at VIRUS COVID-19 Registry
COVID-19 Biorepository
In response to the emergence of the novel beta coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the COVID-19 Biorepository was developed to facilitate innovative research conducted by investigators at Boston Medical Center (BMC) and Boston University (BU). The Biorepository is made up of samples contributed from an ongoing prospective cohort of COVID-19 patients as well as discarded clinical samples from BMC.
The Biorepository contains plasma, serum, PBMCs, viral transport media from naso/oropharyngeal swabs, saliva, stool, rectal swabs, and urine. Discarded clinical samples (blood and swabs) from COVID-19 negative controls are also available. The Biorepository Scientific Review Committee (SRC), an executive committee of faculty from across BMC and BU and led by co-chairs Stephen Pelton, MD, and Chris Andry, PhD, oversees the allocation of COVID-19 samples to scientifically rigorous and innovative research. Since its launch in May 2020, the SRC has approved eight proposals that are listed below.
Applications are accepted on a rolling basis (apply here). Investigators interested in leveraging Biorepository samples in their research are encouraged to contact the SRC for consultation.
The prospective COVID-19 cohort (a component of the BMC/BU COVID-19 Biorepository) is in partnership with the Massachusetts Consortium of Pathogen Readiness (MassCPR). This collaborship provides access to samples collected across MassCPR sites, including Mass Brigham sites, Tufts, UMass, and BMC. As a member site, our researchers are encouraged to apply for access to this broader repository of samples from the MassCPR.
More information can be found here.
For all inquiries about the COVID-19 Biorepository, please contact COVIDBiorepository@bmc.org.
RNT Support for COVID Research
In response to the need for rapid implementation of COVID-19 research, the Research Navigator Team (RNT) provided direct services for several studies. For the Pfizer vaccine trial, the RNT assisted with the development and data management of the pre-screening RedCap survey and provided the research team with a daily updated database on potential participants to contact. The RNT also called more than 120 participants over a two week period to schedule vaccine visits.
For 17 other COVID-19 studies, the RNT facilitated protocol implementation and laboratory services through the GCRU. In addition, the RNT prepared the IRB application and supporting documents to quickly mobilize a study to validate saliva samples for a BU SARS- CoV-2 assay.
RNT Bridge Study Coordinator Gaps
Through a collaboration between the CTSI and the Department of Medicine (DOM), a Research Navigator was hired as part of the RNT team to bridge personnel gaps in study implementation in the DOM.
The Research Navigator effectively worked on eight different studies and served as a lead project manager/study coordinator for three studies by Drs. Ghai, Neogi, and Beck. The PIs were very satisfied with this RNT service. Dr. Neogi commented that the RNT member was:
“a stellar study coordinator and project manager. Her attention to detail and exceptional organizational skills were critical to the success of a fast-moving COVID-19 randomized clinical trial. Without [the RNT member], it would not have been possible for our institution to engage in this highly critical and clinically relevantCOVID-19 trial. The service provided by the CTSI enabled us . . . to rapidly deploy this trial within an exceedingly short timeframe.”
Shining a Health Equity Lens on COVID-19
Early in the pandemic, the Community Engagement (CE) Program acted quickly to increase bi-directional communication between researchers and community stakeholders that could shine a health equity lens on preventing, testing and treating the virus. The existing partnership with three other MA CTSA’s (Tufts, Harvard, UMass) CE programs, was leveraged to collaboratively organize a recurring COVID-19 Community Research Forum series, which started on April 23. Conducted via Zoom and hosted by one of the four MA CTSA CE programs, each forum covers a timely COVID-19 related health topic being addressed by investigators in MA and incorporates health equity concerns raised by community stakeholders. More than 200 participants attended the fourth forum in May on “Building an Equity Research Infrastructure for COVID-Treatment”, which was hosted by Dr. Battaglia, Co-Director of the BU CE Program. The forum series is ongoing and 78% of the hundreds of community and academic partners who attended the first six forums reported learning about the series from email communication.
