In This Article
- Massachusetts General Hospital is collaborating with several other institutions to design and initiate clinical trials that can accelerate the development of a treatment for COVID-19
- The COVID-19 clinical trials platform, led by Keith Flaherty, MD, director of Clinical Research at the Mass General Cancer Center, facilitates collaboration between experts across disciplines
The new coronavirus harbors 15 genes; a seemingly simple organism. But how it infects individuals, spreads from person to person, and causes such a wide range of symptoms and severity are unknown. In the most severe cases, a deleterious immune response depletes energy reserves and damages organs. Yet, an immune response is critical to clearing the virus and generating protection against reinfection.
With rising death rates and a mounting strain on U.S. health systems due to COVID-19, there is a great need to rapidly identify and test existing therapeutic agents that may be able to help. The need for immediate action has prompted Massachusetts General Hospital and other academic medical centers to start designing and executing clinical trials where scientists and investigators can work together in real time.
To bring all players together and to quickly conduct multiple overlapping drug trials, Mass General has launched a COVID-19 clinical trials platform that pairs its infectious disease and immunology experts with organ-specific physiology and clinical care leaders to rapidly implement and conduct new investigator- and industry-initiated clinical trials. The program is led by Keith Flaherty, MD, director of Clinical Research in the Mass General Cancer Center and veteran architect of “basket” trials in oncology.
New COVID-19 Trials Network
In the last week of March 2020 alone, 15 such trials at Mass General were conceived and proposed. Four trials have started.
“There is a lot of activity and 24-hour cycle progress being made on 10-12 fronts when it comes to COVID-19 clinical research,” Dr. Flaherty says. ”I’ve never worked harder in my life. I’ve met dozens and dozens of people who are sprinting right now to get ahead of this pandemic.”
The COVID-19 Clinical Research team will leverage Mass Generals unique capacities for monitoring antiviral and inflammatory responses to potential treatments to understand if these drugs are doing their job, while maintaining a primary focus on improving patient outcomes.
Three committees have been set up to oversee the basket clinical trials: The Clinical Trials Steering Committee, the Scientific Review Committee and the Clinical Trials Implementation Committee.
- The Clinical Trials Steering Committee (CTSC) is a group of investigators that bring expertise in clinical trials across various care environments and therapeutic modalities. They will work with Mass General faculty to develop investigator-initiated and industry-sponsored trials. The CTSC will also directly interact with pharmaceuticals companies offering access to investigational agents
- The Scientific Review Committee provides a scientific assessment of those interventions anticipated to be most impactful
- The Clinical Trials Implementation Committee supports COVID-19 clinical trials that have been prioritized by the COVID-19 Clinical Trial Scientific Review Committee prior to and following IRB approval. They work with investigators and study personnel to address operational issues and monitor patient and staff safety
These trials are using experimental new drugs and a pipeline of “repurposed” antiviral therapies known to be effective in other settings. The drugs target specific molecules produced by the immune system believed to be most responsible for life-threatening organ damage that occurs in severe cases of COVID-19. Deploying unique monitoring tools, the teams can rapidly confirm that a drug is able to break the cycle of viral replication and new cell infection.
“Laboratory research methods have been developed into validated tests in record time in order to more accurately diagnose and track the ability of investigational treatments to tamp down the detrimental immune response and to help patients clear the virus,” Dr. Flaherty says.
Keeping in line with standard anti-cancer strategies where one drug does not usually cure, single drugs that are partially effective will serve as the backbone for combination therapies to be deployed in the next wave of clinical trials. The program is making daily progress in developing and implementing a portfolio of clinical trials to follow the initial wave of studies.
Going Beyond Therapeutics
Clinical research at Mass General goes beyond therapeutics. Experts in the development of digital technologies have assembled and are deploying tools for early detection of COVID-19-related symptoms, monitoring of disease course and tracking recovered patients’ well-being for long-term consequences. These approaches will enable investigators to collect data on COVID-19 patients outside of the hospital and offer the possibility of detecting COVID-19 in otherwise asymptomatic individuals.
Another goal is to develop and distribute preventative therapies. Mass General is currently designing a clinical trial for an antiviral drug to protect families and household contacts of suspected or known COVID-19 infected individuals.
To inform and optimize vaccine development against the recurrence of COVID-19, Mass General is researching immune responses that clear the virus, with the aim of understanding which protein component of the virus is being targeted by antibodies.
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