publication date: Apr. 17, 2020
AstraZeneca trial to test Calquence in COVID-19 patients
AstraZeneca said it will initiate a randomized, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients.
The trial design is based on scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines and on encouraging early clinical data. Calquence is a next-generation, highly selective BTK inhibitor currently used to treat certain types of blood cancers.
The trial, called CALAVI, is based on early clinical data with Calquence demonstrating that a decrease in inflammation caused by BTK inhibition appears to reduce the severity of COVID-19-induced respiratory distress. The goal of the trial is to evaluate the efficacy and safety of adding Calquence to best supportive care (BSC) to reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms.
“We can confirm that NCI is involved with administration of off-label use of acalabrutinib in a small number of selected patients with severe COVID-19,” NCI said in a statement. “While some clinical benefit has been observed in select patients with advanced lung disease caused by COVID-19, it is premature to conclude that it will provide benefit across patients with advanced lung disease due to the very early and limited use of this agent in COVID-19 at this time.
“Thus, it will be necessary to gather data from randomized, controlled clinical trials in order to understand the best and safest treatment options for patients. NCI’s chief concern is the safety and well-being of patients, caregivers, and researchers, and staff.”
This large, multicenter, global, randomized trial uses a two-part patient-centric design developed in record time to accelerate data capture and analysis. Part One evaluates the addition of Calquence to BSC versus BSC alone in patients hospitalised with COVID-19 who are not in the intensive care unit. Part Two evaluates the addition of Calquence to BSC in a cohort of patients in the ICU.
“With this trial, we are responding to the novel insights of the scientific community and hope to demonstrate that adding Calquence to best supportive care reduces the need to place patients on ventilators and improves their chances of survival,” José Baselga, executive vice president and head of Oncology R&D at Astrazeneca, said in a statement. “This is the fastest launch of any clinical trial in the history of AstraZeneca.”
The CALAVI trial is expected to open for enrollment in the coming days in the U.S. and several countries in Europe. Wyndham H. Wilson, of NCI, will serve as the principal investigator of the trial.
“Given the well documented role of the protein BTK in regulating inflammation, it is possible that inhibiting BTK with acalabrutinib could provide clinical benefit in patients with advanced COVID-19 lung disease,” Louis M. Staudt, chief of NCI’s Lymphoid Malignancies Branch and senior investigator of the CALAVI trial, said in a statement. “As with all new treatments, it will be necessary to gather data from clinical trials in order to understand the best and safest treatment options for patients.”
Clinical trial accruals at OneOncology increase in the face of COVID-19
Enrolling patients in clinical trials at OneOncology partner practices has slightly increased in March and April, as the COVID-19 pandemic hit its communities hardest.
OneOncology, a national partnership of independent, community oncology practices, includes five large community oncology practices representing over 400 physicians practicing at more than 160 sites of care in the United States.
“Elective medical procedures have stopped, but caring for cancer patients isn’t elective,” Jeff Patton, OneOncology’s acting CEO and president of Physician Services, said in a statement. “Not only do community oncology centers remain open, providing patients life-saving treatments, we also continue to provide clinical trials at a steady to increased rate. Our centers are continuing to fulfill our collective mission.”
When the Centers for Medicare and Medicaid temporarily loosened its regulations to allow providers to be reimbursed for telehealth visits, the agency allowed researchers to keep some clinical trials open by evaluating and enrolling out-of-state patients.
“By loosening the regulations at both the federal and state levels, we were able to evaluate patients for eligibility in clinical trials that we otherwise couldn’t because of state licensing requirements,” Natalie Dickson, chief medical officer at Tennessee Oncology and chair of OneCouncil, the partnership’s all-physician committee, said in a statement.
American Cancer Society opens COVID-19 tracking study
The American Cancer Society is inviting participants to join its ongoing Cancer Prevention Study 3 (CPS-3) to use a new app to help investigators track the COVID-19 epidemic and inform future research efforts.
The app, the COVID Symptom Tracker, was created by doctors and scientists at the Harvard T.H. Chan School of Public Health, Massachusetts General Hospital, King’s College London, and Stanford University School of Medicine, working in partnership with the health science company ZOE. It is available to anyone in the United States or United Kingdom.
Participants of the study are asked to download the app and track whether they feel any symptoms each day.
The goal of the app is to:
Better understand symptoms of COVID-19,
Evaluate how fast the virus is spreading in different areas,
Identify high-risk areas in the country,
Identify who is most at risk by better understanding symptoms linked to health conditions; and
Identify the exposure of healthcare workers to COVID-19.
“By inviting CPS-3 participants to use this app, we hope to be able to help address the immediate and long-term needs of cancer patients and survivors,” Alpa Patel, senior scientific director, epidemiology research and lead investigator for CPS-3, said in a statement. “In the short term, data gathered from the app will help characterize the progression of symptoms and trajectories related to coronavirus. Over time, the data can be combined with CPS-3 data to study the longer-term health effects related to infection, including in vulnerable populations like cancer survivors.”
The Cancer Prevention Study includes more than 300,000 participants from 35 states and Puerto Rico who completed a comprehensive baseline survey that included extensive medical, lifestyle, and other information. Participants are contributing to a better understanding of the roles of lifestyle, genetic, and other factors in cancer.
COVID-19 Tracker can be used with other major studies, including the Nurses’ Health Study, one of the largest and longest-running scientific studies in the world with 280,000 participants, many of whom are active health care workers treating people with COVID.
Research!America urges Congress to modify budget caps, increase FY21 funding for health agencies
Research!America is urging Congress to modify the budget caps and increase funding for health agencies for FY21 in light of the COVID-19 pandemic.
The letter from President and CEO Mary Woolley follows:
“Dear Chairman Shelby, Chair Lowey, Vice Chairman Leahy, and Ranking Member Granger:
“On behalf of the Research!America alliance, please know how sincerely grateful we are for your bipartisan efforts to mitigate the devastating effects of the COVID-19 pandemic. Your determination to advance the Fiscal Year 2021 appropriations process is an important facet of those efforts, and we deeply appreciate your leadership and commitment.
“In that context, we fully support the strategy of modifying the FY21 budget caps in a manner that enables our nation to end the COVID-19 threat and dramatically build out our public health threat preparedness and response capabilities. COVID-19 is a warning our nation must heed, knowing that the next threat could follow directly on the heels of COVID-19.
“Further, we firmly believe that FY21 funding should respond to what we as a nation are witnessing in real time: research-driven medical and public health progress conveys value to society that profoundly exceeds our investment in it.
“It is not only imperative to ramp up COVID-19 related funding for NIH, CDC, FDA, AHRQ, NSF, BARDA and our nation’s other research and public health agencies; it is imperative to assign a higher funding priority to the day-in-and-day-out efforts of these agencies to combat deadly and debilitating health threats and to ensuring our nation’s research ecosystem can emerge from COVID-19 stronger than ever.
“By modifying the budget caps and prioritizing funding for the Labor, Health and Human Services, Education, and Related Agencies Subcommittee, Congress can begin to empower a future in which emerging health threats like COVID-19 cannot blindside our nation, and longstanding health threats like Alzheimer’s and cancer cannot rob Americans and populations across the globe of hope, independence and time.
“Thank you again for your considered leadership, and please thank your respective staff members for their hard work in support of your efforts.”
NAS, NAE, and NAM presidents: U.S. funding for WHO should not be interrupted during COVID-19 pandemic
The presidents of the National Academy of Sciences, National Academy of Engineering, and National Academy of Medicine are urging the U.S. government to continue funding for the World Health Organization during the COVID-19 pandemic. NAS President Marcia McNutt, NAE President John L. Anderson, and NAM President Victor J. Dzau wrote the following:
“It is critical for the U.S. to continue its funding for the World Health Organization in the midst of the COVID-19 pandemic, given the WHO’s lead role in coordinating an international response, especially in developing countries. The WHO’s leadership in helping to curb the pandemic in other countries undoubtedly benefits the United States as well, as we cannot begin to fully recover here until the threat of the pandemic subsides in other nations. Even a temporary halt in U.S. funding would have a potentially damaging impact on the WHO’s essential activities and global health security.
“Continued funding to the WHO is critical to ensure global access to primary care and essential medicines; train the health workforce; improve monitoring and prepare for future public health emergencies; prevent noncommunicable diseases; and promote mental health, among countless other important services. Any threat to WHO’s funding could cut off a lifeline for low- and middle-income countries and place hundreds of millions of people at risk.
“The U.S. has long been a leader in global health, and we must not reverse course now. For more than 20 years, the National Academies have conducted periodic assessments of U.S. strategic priorities in global health to inform federal policymakers. Our 2017 report Global Health and the Future Role of the United States concluded that ‘the U.S. government should maintain its leadership position in global health as a matter of urgent national interest and as a global public benefit that enhances America’s international standing.’ The National Academies stand ready to evaluate U.S. investment in global health, but the nation’s commitment to funding the WHO should not waver during this pandemic.”
White House expands coverage for essential diagnostic services
Centers for Medicare & Medicaid Services and the Departments of Labor and the Treasury issued guidance to enable Americans with private health insurance to get coverage of COVID-19 diagnostic testing and other related services, including antibody testing, at no cost.
Issued on April 11, the guidance implements the recently enacted Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act, which require that private health issuers and employer group health plans cover COVID-19 testing and certain related items and services furnished during the COVID-19 pandemic, with no out-of-pocket expenses.
The guidance requires group health plans and group and individual health insurance to cover diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test.
Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
Bipartisan bill proposes telehealth expansion
House Health Subcommittee Chair Anna G. Eshoo (D-CA) and Rep. Don Young (R-AK) introduced H.R. 6474, the Healthcare Broadband Expansion During COVID-19 Act, which would provide $2 billion to expand telehealth and high-quality internet connectivity at public and nonprofit healthcare facilities, including mobile clinics and temporary health facilities deployed to respond to the coronavirus pandemic.
Nebraska Medical Center develops infectious aerosol capture mask to protect health care workers
Health care workers at Nebraska Medical Center began using Infectious Aerosol Capture Masks to capture exhaled aerosolized particles at their source from patients.
Approved by the Nebraska Medicine Innovation Committee, the hospital plans to initially deploy the IACM in the operating room for use with patients who aren’t showing symptoms of COVID-19, but may or may not have the disease.
Steven Lisco, chair of the UNMC Department of Anesthesiology, developed the mask, which was put to use April 15
The device is intended for use on patients undergoing monitored anesthesia care, and will be used during and after emergence from general endotracheal anesthesia, as well as in the post-anesthesia care unit. If successful in this environment, the IACM could also be used for patients confirmed to have COVID-19 and are receiving care in the ICU or emergency department.
Patients with COVID-19 produce microscopic aerosol particles, which fill the patient’s environment and increase the risk of disease transmission. A small percentage of patients also may produce aerosols when not showing symptoms or before showing symptoms.
These patients are a challenge for providers, as they may unknowingly produce infectious aerosols when coughing, wearing supplemental oxygen or undergoing aerosol-generating procedures like intubation and extubation—all common occurrences in operating rooms and in post-anesthesia care units.
The IACM device uses a face tent positioned upside down with a viral filter attached, connected to wall suction. The apparatus attaches to the vacuum source via standard suction tubing adapted to the device via a plastic piece created with a 3D printer by Nicholas Markin, director of perioperative imaging.
“The IACM performed very well in laboratory testing in conjunction with a nasal device used to deliver supplemental oxygen, catching more than 90% of airborne particles expelled in the mask, ultimately preventing the aerosol from entering the patient environment,” Lisco said in a statement. “Even when the vacuum wasn’t turned on, the mask was still 85% effective as a barrier.”
In these areas, patients are often given nasal cannula oxygen, which has been shown to increase the rate and density of aerosolized particles, Lisco said.
“We think it is far superior to put this device on patients in the PACU or ICU versus a surgical mask over a nasal oxygen delivery device,” Lisco said.
FDA authorizes blood purification device to treat COVID-19
FDA issued an emergency use authorization for a blood purification system to treat patients, ages 18 and over, with confirmed COVID-19 admitted to the intensive care units with confirmed or imminent respiratory failure.
The authorized product reduces the amount of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a cytokine storm that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
FDA issued this emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
Adolescent, young adult cancer non-profits provide guidance on COVID-19
Six non-profit adolescent and young adult cancer advocacy organizations have launched CovidAYACancer.org, a resource for young people with cancer and the health professionals who treat them.
Teen Cancer America, Stupid Cancer, The Leukemia and Lymphoma Society, Cancer and Careers, Lacuna Loft and CureSearch have formed an alliance with oncology specialists, including Craig Nichols, Archie Bleyer and Stu Seigel, to develop the website.
CovidAYACancer.org aims to be a repository for critical information specifically benefittng AYA cancer patients, patient advocates and medical professionals working with this unique population.
Oncologists in the AYA cancer field treat immunocompromised patients who are at elevated levels of risk as a result of COVID-19.
CovidAYACancer.org provides AYA cancer patients and survivors with financial resources, virtual events, employment and psychosocial support. It plans to provide access to online supportive programs and guidance to patients and their families.
The site also provides guidelines for doctors and frontline health teams. Nichols, Bleyer and Siegel have been consulting with colleagues about best practices during COVID-19, as normal protocols for oncological treatment have changed significantly.
The CovidAYACancer alliance is supported by international pharmaceutical company Servier, which is providing coordination and technical support.
FAQs and Guidances
American Society of Clinical Oncology FAQ: Emerging issues and challenges in caring for patients with cancer during the coronavirus pandemic
American Association for Cancer Research FAQ: Information on virtual annual meetings
American Cancer Society FAQ: Common questions about the new coronavirus outbreak
National Coalition for Cancer Survivorship webinar with Otis Brawley
Society for Immunotherapy of Cancer Resources: Patient management and basic and translational research
Community Oncology Alliance resources: Coronavirus (COVID-19) practice resources and protocols
Leukemia & Lymphoma Society FAQ: Resources and what you should know about the coronavirus
American Society for Radiation Oncology FAQ: COVID-19 recommendations and information
Joint recommendations for treatment of patients with breast cancer
American College of Surgeons resources: For the surgical community
Society for Immunotherapy of Cancer resources: Implications for patients, translational research
GO2 Foundation for Lung Cancer resources
Adolescent and young adult resources
American Society for Transplantation and Cellular Therapy resources
European Blood and Marrow Transplantation Society recommendations
World Marrow Donor Association resources
National Institute for Health Care Management Foundation resources