A group photo of the COVID-19 Clinical Trial Unit, part of the Mount Sinai Infectious Diseases Clinical and Translational Research Center.
When the COVID-19 pandemic ramped up in New York City in March 2020, the disease was so novel there was no approved treatment for it.
“We saw people come to the hospital with COVID-19, and without specialized treatments, many died,” said Sean Liu, MD, PhD, Associate Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai. “I remember feeling helpless, and helplessness is probably the worst feeling that a doctor could experience, because people come to you for help but there is only so much you can do or give.”
With a dire need to discover treatments for patients, the Mount Sinai Infectious Diseases Clinical and Translational Research Center (CTRC) formed the COVID-19 Clinical Trial Unit (COVID CTU) in June 2020 to find ways to stop the disease.
“We already had experts beginning the effort, and with the support of Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine, and under the leadership of Judith Aberg, MD, Director of the CTRC, we were able to form the COVID CTU and go all in to stop COVID-19,” said Dr. Liu, who was tapped as Medical Director of the research unit.
The COVID CTU conducted interventional studies in all aspects of tackling COVID-19, including several drugs that were ultimately approved by the U.S. Food and Drug Administration (FDA). These include Regeneron’s monoclonal antibody therapies, Gilead Sciences’ remdesivir, and two COVID-19 vaccines.
Judith Aberg, MD, Director of the Mount Sinai Infectious Diseases Clinical and Translational Research Center (left) and Sean Liu, MD, PhD, Medical Director of the COVID-19 Clinical Trials Unit (right).
In this Q&A, Dr. Liu and Dr. Aberg share their experience of how the COVID CTU worked tirelessly throughout the pandemic, and where it is headed in the future.
How did the COVID CTU come to be formed?
Dr. Aberg: We were able to build upon the infrastructure that was created for HIV clinical trials, along with the support of many, to immediately start two different drug trials for COVID-19. One drug aimed at the SARS-CoV-2 virus and the other was a potent anti-inflammatory. And I must say, our prompt efforts paid off. We were able to give remdesivir, an antiviral drug, via a compassionate use application on March 9—within two days of the admission of our first patient at Mount Sinai West.
Dr. Liu: When the pandemic first hit, I was working as a hospitalist—someone who cares for admitted patients—at Mount Sinai Queens, and Dr. Aberg asked me to help with clinical trials at The Mount Sinai Hospital.
As pharmaceutical companies started developing more candidates for COVID-19 treatment, the team working on the initial studies started taking on more studies, supported by the CTRC, the Infectious Diseases Division, and the Medicine Clinical Trials Office at the Icahn School of Medicine. When we realized we sorely needed to expand and formalize a team for COVID-19-related trials, Dean Charney provided seed funding, and during the summer of 2020, we were able to hire more staff needed to run the trials.
How big was the COVID CTU then, and how has it grown since?
Dr. Liu: It started with 11 people, including six from the CTRC. By 2021, we had 25 staff.
What was it like fielding a clinical trials team during the pandemic?
Dr. Liu: Dr. Aberg already had a research unit working with HIV before the pandemic, and we pooled together a staff of clinical researchers, project managers, research nurses, coordinators, and regulatory staff. It was incredible seeing so many people come together quickly to tackle one of the biggest challenges we’ve faced in health care.
In addition to assessing the effectiveness of industry-developed treatments, the unit became a translational springboard where basic science researchers could come to us with their ideas, and we could help apply them in a phase 1 study, creating a bridge between preclinical and in-human studies.
What were some of the COVID-19 trials done at Mount Sinai?
Drs. Aberg and Liu recall some of the studies done by the COVID CTU:
Remdesivir: The antiviral drug is currently approved by the FDA to treat patients hospitalized for COVID-19. We initially opened trials for this drug via an emergency investigational new drug application at seven hospitals. In less than a month, we opened the Gilead-sponsored studies at four hospitals.
Monoclonal antibodies (mAbs): We were involved in Regeneron’s mAb studies in many different settings. These included an outpatient treatment study, an outpatient post-exposure prophylaxis study, and a pre-exposure prophylaxis study. One of Regeneron’s mAb that we did a study on was sarilumab, a potent IL-6 inhibitor. While this study did not demonstrate the robust findings of another IL-6 inhibitor we had worked on, Roche’s tocilizumab, it was the first study that paved the way for potent immune-modulating therapies to treat COVID-19 as we do currently.
mRNA vaccine: We were heavily engaged in the Pfizer/BioNTech COVID-19 vaccine trial, enrolling hundreds of participants from diverse backgrounds. Mount Sinai was recognized for enrolling the 40,000th participant in the initial phase 3 trial.
NDV-HXP-S: Mount Sinai developed its own COVID-19 vaccine, which can be delivered via injection or the nose. The technology was developed by our Microbiology Department, and the COVID CTU helped run the phase 1 trial. With our data, the vaccine went on to be developed further in other countries and has gone on to be approved as booster shots in Mexico and Thailand.
Hyperimmune immunoglobulin: This was a blood product-derived treatment using extracted antibodies from a pool of convalescent plasma donors who had recovered from COVID-19. With hyperimmune immunoglobulin, the patient is receiving a known purified amount of antibody from the donor. Studies are ongoing to identify who would benefit the most as well as timing in relation to onset of symptoms.
The COVID Clinical Trials Unit team received a letter of recognition for enrolling 280 participants—as well as the 40,000th participant—in the Pfizer/BioNTech COVID-19 vaccine trial.
What were some lessons learned on running clinical trials to address the pandemic?
Dr. Liu: There were so many studies to undertake, but we had to learn to focus. A part of it was trial and error, but as we gained experience, we became better at identifying what studies were likely to yield promising results. Some clinical trials might sound great on paper, but given limited resources, we had to weigh what factors went into them—such as enrollment opportunity or viral targets—and choose our trials accordingly or make adjustments.
Dr. Aberg: Decisive action can help change the trajectory of a pandemic. When Regeneron finalized its protocol for sarilumab trials, within seven days we opened a randomized, placebo-controlled trial of the drug. Its interim results, along with our remdesivir clinical trials and observational use of tocilizumab, helped advise us of the narrow window where these types of drugs may be effective to prevent patients from developing respiratory failure, requiring them to go on a ventilator, and even death.
What’s next for the COVID CTU?
Dr. Aberg: The COVID CTU no longer needed to be distinct from the CTRC. However, we are still involved in COVID-19 studies. One such trial is RECOVER-VITAL, a National Institutes of Health (NIH)-funded study to explore whether Pfizer’s Paxlovid™ treatment can be used to treat the chronic disease state commonly referred to as long COVID.
We are also in the NIH-funded Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE) consortium. A COVID-19 study we are involved in as part of the network is STRIVE-1, exploring whether the antiviral medication ensitrelvir can reduce symptoms and duration of hospitalization in persons with moderate to severe COVID-19. Another STRIVE COVID-19 study is exploring the additional use of immunomodulating agents for hospitalized patients.
Beyond COVID-19, we completed enrollment for a few other studies, including an mRNA shingles vaccine study by Pfizer and an exciting novel dual-affinity retargeting molecule for HIV. There are other studies we anticipate opening in 2025, including a C. difficile vaccine, as well as several HIV prevention and treatment studies.
Dr. Liu: We will never forget how the COVID-19 pandemic changed our lives. Thanks to tested vaccines and treatments, we are able to return to a normal life of packed movie theaters and lecture halls. Some of our team of skilled and knowledgeable research staff are being transferred to other areas where groundbreaking research is occurring throughout the Mount Sinai Health System. We are forever grateful for the contributions of the COVID CTU in reducing the morbidity and mortality from the COVID-19 pandemic.
From left: Farid Khan, MBBS, co-chair of the Fellows in Training Program of the New York Chapter of the American College of Cardiology; Helen Gordan; and Samuel Kim, MD, the chapter’s program chair
Helen Gordan, a second-year medical student at the Icahn School of Medicine at Mount Sinai, recently won best clinical case abstract at the New York Chapter of the American College of Cardiology Fellows in Training competition.
Her abstract titled “Unraveling a Genetic Diagnosis After a Near Drowning Incident” describes the diagnostic odyssey of a 9-year-old boy who was cared for at Mount Sinai Kravis Children’s Hospital after he was resuscitated from near-drowning in a swimming pool.
Careful sleuthing ultimately elicited a novel cardiac genetic cause. The patient made a full recovery and is being treated successfully, and the genetic discovery will permit others to benefit in the future.
Ms. Gordan’s award is all the more impressive for having won it as a second-year medical student, competing against much more senior trainees in internal medicine and cardiology fellowship training. Ms. Gordan presented the work in an oral presentation in December.
In a Q&A, Ms Gordan discusses why she chose the Icahn School of Medicine at Mount Sinai, what has drawn her to explore pediatric cardiology as a potential career choice, and her research interests.
What inspired you to explore pediatric cardiology as a medical student?
From the beginning of medical school, I was drawn to specialties that offer meaningful long-term patient relationships and combine medical management with precise interventions. Pediatric cardiology fulfills both these criteria and more. Since every heart is unique, cardiologists must rely on fundamental physiologic principles to tailor treatments to each case. The opportunity for early intervention, especially in congenital heart defects, has an immeasurable impact on long-term outcomes, enabling children to thrive and lead full lives. It opens the door to the kind of long-term relationships with patients and families that I desire in my career.
What are your research interests?
My research interests lie at the intersection of engineering and clinical care. My undergraduate degree is in electrical engineering, so I am particularly interested in how technology can be harnessed to both enhance therapeutic outcomes and improve access to care for underserved populations. For example, asynchronous online care platforms—which allow physicians to assess patient concerns and provide treatment through messaging, patient portals, or online questionnaires— offer unique opportunities to bridge gaps in accessibility, especially for resource-limited settings. Understanding how these models can integrate with chronic disease management, including heart disease, is a growing area of interest.
What does winning this abstract award mean to you and how will it help propel your studies?
I was incredibly excited and honored to win this case competition. It has encouraged me to continue to explore challenging questions and raise questions about frameworks for diagnoses. It has allowed me to receive feedback from experts that have both refined my skills and broadened my perspective. Most importantly, it has underscored the importance of great mentorship and collaboration. I am incredibly grateful for the support I received from Dr. Barry Love and Dr. Amy Kontorovich while working on this case.
Why did you choose the Icahn School of Medicine school and how has the medical school experience been so far?
The Icahn School of Medicine stood out to me because of its emphasis on fostering diverse academic backgrounds. Coming from an engineering discipline, I was eager to join a medical institution that values multidisciplinary approaches to problem-solving and allows students to incorporate their own interests into their clinical training. The culture of innovation and research has completely exceeded these expectations. I have been able to learn about entrepreneurship in medicine through Sinai BioDesign’s THRIVE program, explore access-to-care barriers through a summer global health research program, and explore different specialties with the support of amazing faculty. My experience has been exceptional, largely due to the supportive mentorship I’ve received from Dr. Love, Dr. Gault, and many others.
What do you hope your impact will be on patients, field, and practice?
First and foremost, I hope to be an exceptional clinician. I would like to provide the expertise and empathy patients need when facing scary and vulnerable moments. I also aspire to combine innovation with equitable care to make an impact. I hope to provide solutions that enhance quality of life while ensuring accessibility to care, regardless of socioeconomic or geographic barriers. Ultimately, I want my career to serve as a bridge between disciplines and help to drive advancements that improve both individual patient experiences and systemic health care delivery.
Jose Silva, PhD, left, Program Director, Master of Science in Biomedical Science, and Professor, Pathology, Molecular and Cell Based Medicine, and Oncological Sciences, shown in his lab.
The Graduate School of Biomedical Sciences, part of the Icahn School of Medicine at Mount Sinai, has announced a new curriculum structure for its Master of Science in Biomedical Science (MSBS) program.
The MSBS program, started in 2005, features the multidisciplinary research education available at the school, a commitment to translating fundamental biomedical research into disease prevention and novel therapies, and a dedication to preparing students to contribute to the biomedical enterprise in the non-profit or for-profit sectors.
The program prepares students for a range of health-related advanced degree programs and careers, whether focused on medicine, such as the MD program; research, such as the PhD and MD-PhD programs; or manager-level employment in the clinical and industrial sectors. Eligible students should have a degree in science or a related discipline from an accredited college or university.
“For 20 years, our MSBS program has successfully prepared our students for future success in advance degree programs. Nonetheless, we recognized that a changing job environment required us to provide students with more options, and the new program structure does just that,” says Eric Sobie, PhD, Senior Associate Dean for Master’s in Basic Science Programs.
The program has been restructured to address the changing educational landscape. The new MSBS program offers four distinct tracks that target different types of students and provide greater flexibility for how students can complete the program. The total minimum credits has been reduced from 45 to 36 credits over two to four semesters.
Students will choose their track based on their career goals and stage of life:
Track 1: Post-Baccalaureate Pre-doctoral (pre-PhD or pre-MD-PhD): This full-time, four-semester track requires students to complete a master’s thesis based on original laboratory research and features a staggered block schedule to facilitate focused study. Students will learn the fundamentals of biomedical sciences while engaging in hands-on research in the laboratories of their chosen Principal Investigators.
Track 2: Post-Baccalaureate Pre-medical (pre-MD): This full-time, three-semester track also follows a block schedule structure. Students graduate with a capstone project and a final comprehensive examination. This track allows students interested in applying to MD programs to better prepare for the MCAT exam by offering a lighter course load during the spring semester. Students also benefit from non-curricular experiences available at The Mount Sinai Hospital, such as clinical shadowing.
Track 3: Industry/Clinical/Professional Development: This flexible track, available in three or four semesters, combines a block schedule alongside a capstone project. It caters to individuals working in the clinical, educational, or private sector who aim to enhance their skills and advance their careers into higher-ranked, better-paid positions.
Track 4: Accelerated Industry/Clinical/Professional Development: This faster-paced version of Track 3 consists of two full-time semesters with a block schedule, a capstone project and a final comprehensive examination. It is designed for individuals seeking to enhance their skills within a condensed time frame.
“Our new curriculum retains our unique hands-on training while offering more options and flexible tracks to support your career goals. Whether you’re interested in research, healthcare, or industry, and whether you’re a recent graduate or a professional looking to advance, we’re committed to helping you gain the knowledge and experience needed to take your career to the next level,” says Jose Silva, PhD, MSBS Program Director and Professor, Pathology, Molecular and Cell Based Medicine, and Oncological Sciences.
These tracks will continue to leverage the multidisciplinary training areas available at the Icahn School of Medicine at Mount Sinai through the PhD programs in Biomedical Sciences, Neuroscience, and the recent joint PhD program in Health Sciences in Engineering with the Rensselaer Polytechnic Institute. This structure allows students to earn a specific concentration or specialization notation on their transcripts by completing a minimum of six credits in concentration-related elective courses, in addition to the required courses and a thesis or capstone project in concentration-related fields.
Students can choose from nine specialty areas to tailor their studies, including:
Cancer Biology
Disease Mechanisms and Therapeutics
Development, Regeneration, and Stem Cells
Immunology
Genetics and Genomics
Microbiology
Neuroscience
Artificial Intelligence and Emerging Technologies in Medicine
Health Sciences in Engineering
Visit our website or contact us to learn more about this program and find out which track aligns with your schedule and career goals.
Young children of parents who declined the COVID-19 vaccine were about 25 percent less likely to receive vaccination against measles, mumps, and rubella (MMR), according to the results of a new study. Historic political and socioeconomic disparities remain important predictors of MMR vaccine hesitancy, but the pandemic appears to have further increased MMR skepticism, researchers said.
“Our research highlights the link between parental characteristics and MMR vaccine uptake, showing how pandemic-related hesitancy may affect other routine vaccines,” said Eric G. Zhou, PhD, Instructor, Pediatrics, Cardiology, and Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, a lead author of the study. “Addressing these disparities, through equitable access and fostering trust and transparency in vaccine safety, is key to protecting children from preventable diseases like measles.”
The researchers conducted a cross-sectional study from July 2023 to April 2024 using a digital health survey to examine national population characteristics.
They analyzed responses from more than 19,000 parents of children younger than 5 years old to examine the association between self-reported parental characteristics (i.e., sociodemographics, politics, COVID-19 vaccination status) and children’s MMR vaccination rates, using logistic regression. The study was published January 16 in the American Journal of Public Health.
Children of parents who received at least one dose of the COVID-19 vaccine had higher MMR vaccination rates (80.8 percent) than did children of unvaccinated parents (60.9 percent). The researchers found higher MMR vaccination rates in the Northeast and Midwest regions of the United States.
“In the United States, we are experiencing a concerning resurgence of childhood vaccine-preventable diseases,” said Ben Rader, PhD, of Boston Children’s Hospital, the study’s corresponding author. “Our research suggests that COVID-19 vaccine hesitancy has fueled increasing MMR vaccine hesitancy, leaving children more vulnerable to highly contagious and life-threatening illnesses like measles.”
From left: Betty Chen, FNP; Rachelle Mallare, RN; Margaret Garrett, FNP; Christian Malatesta, FNP; Berenissis Valenzuela, MA; Karmiely Morillo, Patient Coordinator
The Clinical Research Unit (CRU) is a valued resource hub for researchers at Mount Sinai—providing everything from exam rooms, to research space and specimen storage, to compassionate nursing support, and help with administrative and procedural tasks.
Manisha Balwani, MD, MS, Chief of the Division of Genetics and Genomics, is appreciative of the skill and compassion of the team. “The CRU team have truly been excellent partners in getting rare disease treatments to patients. They have the skills to navigate administering complex therapies while creating a safe environment for patients who are vulnerable and anxious.”
The center was established in 1963 as part of a nationwide effort by the National Institutes of Health to provide dedicated space and resources for conducting medical research across medical disciplines within academic medical centers. Located in the Annenberg Building at The Mount Sinai Hospital, the CRU is a comprehensive resource hub for investigators and the Mount Sinai community who wish to undertake clinical research. Currently there are 122 active ongoing studies across multiple disciplines.
Christian Malatesta, FNP, on staff at the CRU, and at Mount Sinai for 30 years, calls the unit a “hidden gem” that is especially valuable for investigators who do not have the time or resources to implement the clinical procedures required for clinical trials. Along with Betty Chen, FNP, and Unit Nursing Director, Margaret Garrett, FNP, the team of nurse practitioners, one registered nurse, and one medical technician, are able to assist with study-related medical evaluations of research participants, including:
Performing physical examinations
Administering study medications
Adverse event monitoring including telemetry monitoring
Obtaining electrocardiograms
The team also assists with reviewing signed consent forms and the required study-related schedules of events to ensure that all elements are in place to safely and effectively proceed with clinical procedures.
Investigators across the system value their partnership with the CRU.
Alexander Kolevson, MD, a principal investigator on studies in autism spectrum disorder as part of the Seaver Autism Center for Research and Treatment, says, “We believe our work has made major contributions to the field of autism and neurodevelopmental disorders and I’m not exaggerating when I say that we could not have done it without the outstanding CRU team. They are highly skilled and consistently flexible and accommodating. Importantly, our most severely disabled and behaviorally challenging patients are treated effectively with kindness and empathy.”
Stephen Krieger, MD, FAAN, a neurologist at The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, also praises the CRU. “We are currently the only recruiting site in New York City for a trial of a new infused monoclonal antibody for progressive multiple sclerosis (frexalimab), and my team has worked hand-in-hand with the CRU from our initial site assessment and activation through to the enrollment and infusion of our patients. I am very grateful to the CRU team for their professionalism and the warm and compassionate way they have worked with our patients, many of whom have significant disability from their neurological disease.”
“Our teams think of AI as augmented intelligence, versus artificial intelligence,” says Robbie Freeman, DNP, RN, Vice President of Digital Experience and Chief Nursing Informatics Officer at the Mount Sinai Health System. “The goal is to leverage AI as a supportive tool to enhance clinical decision-making—not to replace it.”
He adds, “Risk assessment models and tools for guiding care have always been integral to nursing practice. By combining nursing expertise and critical thinking with the ability to analyze vast amounts of data, AI is transforming how we deliver care, elevating quality and safety to unprecedented levels. In the coming years, this technology will continue to support nursing practice by enabling the creation of highly targeted, personalized care plans for every patient.”
Shown from let: Eric Kim; Prem Timsina, ScD; Arianna Goldman; Dhaval Patel; Maria ‘Vickee’ Sevillano, RN; Kim-Anh-Nhi Nguyen, MSc; Robbie Freeman, DNP, RN; and Arash Kia, MD, MsC
“Every AI project starts with a working group,” says Dr. Freeman, “and that working group always includes the people who are delivering care. For example, if we’re working on a falls-related initiative, we sit down with front-line nurses, with geriatricians, with nurse leaders, and from day one we’re talking together about what might be helpful.”
Currently, Mount Sinai nurses are using a machine learning model that predicts which patients are most likely to fall while in the hospital. The data behind this tool largely came from examining electronic medical record (EMR) data. By combing through nursing notes using recognition algorithms, Mount Sinai also developed an AI tool to better identify which patients are at higher risk for becoming delirious while in the hospital so that tailored preventive interventions could be put in place at the earliest opportunity.
From left: Prem Timsina, ScD; David Reich, MD, Chief Clinical Officer, Mount Sinai Health System, and President of The Mount Sinai Hospital; Robbie Freeman; Matt Levin, MD, and Arash Kia, MD, MsC
Mount Sinai is leading the world in developing a variety of AI products that support nurses and keep patients safe, according to Dr. Freeman.
Another AI product came about when Maria ‘Vickee’ Sevillano, BSN, RN, CWCN, COCN, a Mount Sinai clinical nurse, proposed an idea focused on the prevention of pressure injuries, also known as bed sores.
“We embraced the idea, collaboratively explored its nuances through a co-design process, and partnered with our internal data scientists and software engineers to transform it into a fully realized product,” says Dr. Freeman. “We tested and fine-tuned it, and in early 2024 the idea brought forward was introduced to the clinical setting. This predictive software is currently embedded in our EMR at The Mount Sinai Hospital, and we hope to expand its use as we continue to evaluate the product.”
Mount Sinai has also done a lot of work with a new type of AI called large language models, which, among other tasks, can recognize and generate large amounts of text. One particular study involved examining nursing triage notes to identify predictors for which Emergency Department patients were likely to be admitted to the hospital.
“In many cases the nursing documentation can really power AI,” says Dr. Freeman. “Much of nursing documentation data reflects their expert observations and has predictive power. So, using things like natural language processing algorithms, the nursing observations and assessments are really helpful in the development of AI tools that have broader use and impact. ”Mount Sinai is also using AI to help reduce the amount of time nurses spend doing documentation by rolling out macros—a sequence of computer instructions to automate a task—and tools that can streamline the process and relieve the documentation burden.
Kim-Anh-Nhi Nguyen, MSc, left, and Maria ‘Vickee’ Sevillano, BSN, RN, CWCN, COCN
As this emerging field continues to grow, Dr. Freeman says it is important to note that Mount Sinai has governance in place to ensure there is a solid understanding of how these tools work, that they are safe, and that they are being used in ways that are ethical and sound before they are being used in patient care.
“There’s a science and methodology for ensuring AI products are used responsibly,” Dr. Freeman says. The shared decision-making structure plays a critical role. Mount Sinai is also part of the nonprofit Coalition for Health AI, which brings together a diverse array of stakeholders to drive the development, evaluation, and appropriate use of AI in health care.
“AI is here and has proven it holds promise for thoughtfully revolutionizing care delivery in ways never imagined,” he says.
