For decades, Brigham and Women’s Hospital has been a leader in clinical research studies to advance patient care. Since the start of the COVID-19 pandemic, the Brigham has built on that legacy by working rapidly and collaboratively to address the most urgent challenges of the crisis.
Brigham investigators have led clinical trials to evaluate a new COVID-19 vaccine and therapeutics against the disease. Researchers have come together to better understand the virus that causes COVID-19 to develop treatments and prevent infection. Medical recommendations became COVID-19 guidelines, which have been accessed by clinicians all over the world. In addition, Brigham scientists and engineers are spearheading innovative solutions to help their colleagues, patients and the world beyond on its walls.
“The Brigham was uniquely positioned to have a transformative impact during the COVID-19 pandemic,” said Paul Anderson, MD, PhD, chief academic officer and senior vice president of Research and Education at the Brigham. “The Brigham has the expertise, the advanced technology and some of most highly trained clinicians and researchers in the country. We’re used to performing state-of-the-art research. We’re used to innovating. It’s in our DNA.”
In April of 2020, leadership at the COVID-19 Prevention Network (CoVPN) chose Lindsey Baden, MD, director of the Brigham’s Center for Clinical Investigation (CCI), as the co-principal investigator of an mRNA phase 3 vaccine trial to evaluate the effectiveness and safety of the vaccine and its ability to prevent COVID-19 illness.
“The Brigham was chosen to lead this vaccine trial because of our clinical research experience, the depth of scientific talent and our growing knowledge of COVID-19,” said Dr. Baden. “Taking a leadership role in COVID-19 vaccine trials, the Brigham has worked diligently across industry, academia and government to help launch this clinical trial and others rapidly and safely.”
The mRNA-1273 trial was the first phase 3 trial in the U.S. to test the effectiveness of a vaccine against COVID-19. The Brigham was the only New England hospital to serve as a site in the trial. Phase 3 results from across 99 clinical trial sites, including the Brigham, recently showed that the mRNA-1273 vaccine is 94.5 percent effective in preventing COVID-19.
Throughout the pandemic, Brigham investigators have tested a wide range of therapeutics to treat COVID-19. The Brigham was one of multiple sites around the world for two phase 3 clinical trials to test the safety and efficacy of remdesivir among adults hospitalized with COVID-19. Led by Francisco Marty, MD, an infectious disease expert, the clinical trial helped contribute to remdesivir being the first approved therapeutic for severe COVID-19 disease.
While antiviral medications such as remdesivir took aim at the virus itself, another therapeutic strategy was recently tested at the Brigham to control systemic inflammation. Ann Woolley, MD, MPH, was the site principal investigator for a clinical trial that tested tocilizumab against COVID-19, along with Sarah Nikiforow, MD, PhD, of the Dana-Farber Cancer Institute (DFCI).
“Managing COVID-19 patients requires collaboration across many areas of expertise,” said Dr. Woolley. “Our clinical trial was a collaboration among infectious disease specialists, oncologists, cardiologists and rheumatologists. The Brigham has a multidisciplinary approach to providing care, so we were well-positioned to address the most urgent challenges of this crisis.”
In October, Jean Connors, MD, and Paul M. Ridker, MD, MPH, launched a clinical trial to determine if anticoagulants or antithrombotic therapy can reduce life-threatening cardiovascular or pulmonary complications from COVID-19. As part of the National Institute of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial aims to determine the best treatments for preventing blood clots in COVID-19 patients.
Gregory Piazza, MD, MS, director of the Vascular Medicine Section in the Division of Cardiovascular Medicine, is leading a clinical trial that tests the use of rivaroxaban to reduce clotting risk in COVID-19 patients. The Brigham’s Thrombolysis in Myocardial Infarction (TIMI) Study Group is leading the COVID-PACT clinical trial, investigating the safety and efficacy of anticoagulants in preventing blood clots in critically ill COVID-19 patients.
Since the beginning of the COVID-19 pandemic, the Brigham has been incorporating its accumulated clinical knowledge and rapidly changing medical recommendations into one living document called the COVID-19 Clinical Guidelines. Founded by C. Lee Cohen, MD, MBA, and Edy Yong Kim, MD, PhD, pulmonary and critical-care experts, the website contains procedures for respiratory and pulmonology care, along with two dozen other disciplines.
“The Brigham was one of the first institutions in the U.S. to develop a coded and mobile-optimized website for guidelines to treat COVID-19,” said Dr. Kim, content director of the guidelines. “Our website allowed frontline workers to quickly access specific, concrete guidance that physicians could leverage every day during the health crisis.”
A mix of educational content and clinical protocols, the Brigham’s COVID-19 Clinical Guidelines became a valuable reference tool for hospitals worldwide. There are more than 250 pages of content representing 24 medical disciplines. The website has been accessed by people from over 100 countries. It now has more than 400,000 users and 1.5 million page views.
“Many of the early users were in hospitals in hotspots in New York City,” said Dr. Cohen, editor-in-chief of the COVID Protocols. “Since the beginning of the pandemic, many community hospitals across the country have reached out to express their gratitude for our protocols.”
At the Mass General Brigham Center for COVID Innovation (MGBCCI), colleagues at Massachusetts General Hospital (MGH) and the Brigham research community have been developing innovations to protect frontlines workers and patients.
During the pandemic, Brigham-led research teams at MGBCCI prototyped and tested new personal protective equipment (PPE) and created alternatives to respirators. They found innovative methods to sterilize and reuse face masks, face shields, nasal swabs and respirators. Early in the pandemic, a Brigham team of clinicians and researchers developed an in-house diagnostic test that offered results within twenty-four hours.
“It’s inspiring to see how highly collaborative the Brigham research community has been during this health crisis,” said Jacqueline Slavik, PhD, MMSc, executive director of Brigham Research Institute (BRI). “Our innovation and research efforts have involved countless individuals from many academic institutions, the technology sector, industry and private companies—all of whom are working toward the common goal of mitigating COVID-19.”
Many researchers at the Brigham are focusing their efforts on at-home testing and vaccine distribution. At the MGBCCI, David Walt, PhD, is developing a direct-to-consumer diagnostic test that could be used at home. At Ariadne Labs, Rebecca Weintraub, MD, is researching various vaccine-distribution strategies.
Through the TestBoston study, led by Dr. Woolley, Lisa Cosimi, MD, and Deborah Hung, MD, PhD, investigators are facilitating at-home testing on 10,000 people in Massachusetts to reveal accurate COVID-19 infection rates in Boston. The results could help the state respond better to the pandemic by offering an early warning sign of a surge.
“Throughout the pandemic, physicians and researchers at the Brigham have made pioneering discoveries and created numerous innovations that have helped advance our understanding of COVID-19 and take care of patients who need our help,” said Dr. Slavik. “We are committed to using our vast resources and intellectual capital to solve the world’s most pressing problem.”