For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
As the entire healthcare ecosystem grapples with the COVID-19 virus, more evidence surfaces every day of manifestations beyond fever, respiratory symptoms and fatigue. In fact, a recent publication in the American Journal of Gastroenterology1 concluded that digestive symptoms, such as abdominal pain, nausea, vomiting, diarrhea and loss of appetite, are common in patients with COVID-19.
Because of the lack of respiratory symptoms, these patients typically wait longer from onset of illness to seek care and be admitted to the hospital. The index of suspicion may need to be raised earlier in at-risk patients presenting with digestive symptoms. This knowledge may help with earlier identification of COVID-19, faster time to treatment, earlier quarantine and lower exposure to bystanders.
Implications for Clinical Trials
The global pandemic has significantly impacted trial enrollment. With uncertainty over how long the pandemic will last, many large studies are temporarily on hold; project cancellations are widespread, and more than two-thirds of sites have closed to enrollment.
Given that COVID-19 infection can present with gastrointestinal and liver abnormalities without respiratory illness in asymptomatic volunteers in Phase I trials, ongoing clinical trials may incorrectly report these symptoms as serious adverse events (SAEs). Likewise, ongoing trials might incorrectly attribute these findings, such as elevated liver enzymes, to the investigational drug.
Special considerations must be given to patients with inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), who are currently in clinical trials. Experts from the American Gastroenterological Association (AGA) and The International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) have made a number of valuable recommendations.2
In patients with underlying chronic liver diseases who are in clinical trials, the recommendations are less clear. It is not known if patients with chronic viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD/NASH), decompensated cirrhosis and other genetic/metabolic liver conditions are at higher risk of COVID-19 infection. Patients on immune-suppressing medications for hepatocellular carcinoma and to prevent rejection of a liver transplant should be considered at increased risk for COVID-19, although it is not clear if they are at risk for more severe infection. It has been suggested that immunosuppression prolongs viral shedding. It is uncertain if COVID-19 exacerbates these underlying liver conditions. However, experts from the American Association for the Study of Liver Diseases (AASLD) have issued preliminary guidance.3
Parexel is in a unique space to support the development of diagnostics and therapeutics for this pandemic. As of May 2020, Parexel is involved in more than 150 studies related to COVID-19, including:
Parexel is embracing a full range of virtual solutions that can be incorporated into clinical trials, whenever possible, to help minimize disruptions due to COVID-19. These approaches include:
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Best practices and lessons learned in a challenging IBD study
Jul 19, 2023
New Infectious Disease, Vaccines Head brings clinical, philanthropic experience
Jun 20, 2023
Population diversity: important considerations in vaccine development
Jun 14, 2023
Biotech Showcase: Fireside Chat with Jamie Macdonald
Jan 3, 2022
Master Protocols from Design to Delivery
Sep 30, 2021
What COVID Taught Us About Focus, Innovation, and Leadership
Sep 24, 2021
Decentralized clinical trials - A more patient-centric approach
May 10, 2021
The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development
Feb 8, 2021