Author Interviews, COVID -19 Coronavirus, JAMA / 15.07.2021
Remdesivir: Study Finds No Improved Survival in Hospitalized COVID-19 Patients
MedicalResearch.com Interview with:
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Dr. Ohl[/caption]
Michael Ohl, MD, MSPH
Associate Professor of Internal Medicine-Infectious Diseases
Roy J. and Lucille A. Carver College of Medicine
University of Iowa
MedicalResearch.com: What is the background for this study?
Response: The background is that remdesivir was approved for treatment in 2020 largely based on the results of the Adaptive COVID-19 Treatment Trial 1 (ACTT-1), which found that remdesivir treatment was associated with more rapid recovery from illness among people hospitalized with COVID-19. The intention was that - even if remdesivir did not lead to substantial improvements in survival- it could help people to recover more quickly and be discharged from hospital sooner, potentially opening scare hospital pends to treat more patients during the pandemic.
Dr. Ohl[/caption]
Michael Ohl, MD, MSPH
Associate Professor of Internal Medicine-Infectious Diseases
Roy J. and Lucille A. Carver College of Medicine
University of Iowa
MedicalResearch.com: What is the background for this study?
Response: The background is that remdesivir was approved for treatment in 2020 largely based on the results of the Adaptive COVID-19 Treatment Trial 1 (ACTT-1), which found that remdesivir treatment was associated with more rapid recovery from illness among people hospitalized with COVID-19. The intention was that - even if remdesivir did not lead to substantial improvements in survival- it could help people to recover more quickly and be discharged from hospital sooner, potentially opening scare hospital pends to treat more patients during the pandemic.
Dr. Strauss[/caption]
David Strauss, MD, PhD
Director, Division of Applied Regulatory Science
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Dr. Keire[/caption]
David Keire, PhD
Director, Office of Testing and Research
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
MedicalResearch.com: What is the background for this study?
Response: In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine, a widely used prescription and over-the-counter drug, contained the probable human carcinogen N-nitrosodimethylamine (NDMA). In addition, the petitioner proposed that ranitidine could convert to NDMA in humans; however, this was based on a small clinical study with limitations and an in vitro study that included high level of supplemental nitrite. In response, the FDA immediately alerted the public and began an investigation.
The FDA’s initial research found that the procedures previously used to quantify NDMA were not appropriate for assessing its presence in ranitidine, owing to the use of high temperatures that could convert ranitidine to NDMA during that analysis. New lower-temperature analytical methods found that the amounts of NDMA contained in ranitidine products were 3,000-fold lower than those reported in the citizen petition; however, these lower amounts of NDMA were still above the FDA-acceptable level and could increase over time, prompting the FDA to request the market withdrawal of ranitidine products.
The FDA noted, however, that if ranitidine products could be manufactured to control NDMA amounts, they could be allowed back on the market—but additional information would first be needed to understand whether NDMA could form in vivo from ranitidine in humans.
Dr, Ferguson[/caption]
Michael Ferguson, PhD
Instructor in Neurology | Harvard Medical School
Lecturer on Neurospirituality | Harvard Divinity School
Center for Brain Circuit Therapeutics
Brigham and Women’s Hospital
MedicalResearch.com: What is the background for this study?
Response: Over 80% of the global population consider themselves religious with even more identifying as spiritual, but the neural substrates of spirituality and religiosity remain unresolved.
MedicalResearch.com: What are the main findings? Where is this circuit located in the brain? What other effects does this circuit control or influence?
Response: We found that brain lesions associated with self-reported spirituality map to a human brain circuit centered on the periaqueductal grey.
Dane Kim[/caption]
Dane Kim, Dental Student
University of Pennsylvania School of Dental Medicine
MedicalResearch.com: What is the background for this study?
Response: This large study was inspired, in part, by a previous publication, Gustatory Function After Third Molar Extraction (Shafer et al. 1999), which examined the effect of third molar extractions on human taste function. Their work was based upon more severe extractions and followed patients only up to six months after their surgery. Studies examining taste function over a longer period, i.e., beyond six months from the surgery, were non-existent.
The Smell and Taste Center of Penn Medicine, which is the only center of its type in the United States, has a large unique database of patients who have been thoroughly tested for both smell and taste function. This provided us with the opportunity to compare data from hundreds of persons who had previously received third-molar extractions to those who had not received such extractions. Importantly, the extracts had occurred years before thee taste testing.
Dr. Kelley[/caption]
Mireille E. Kelley Ph.D.
Staff Consultant for Engineering Systems Inc.
MedicalResearch.com: What is the background for this study?
Response: Youth and high school football players can sustain hundreds of head impacts in a season and while most of these impacts do not result in any signs or symptoms of concussion, there is concern that these repetitive subconcussive impacts may have a negative effect on the brain.
The results of this study are part of an NIH-funded study to understand the effects of subconcussive head impact exposure on imaging data collected at pre- and post-season time points. The present study leveraged the longitudinal data that was collected in the parent study to understand how head impact exposure changes among athletes from season to season and how that relates to changes measured from imaging.
Dr. Els Broens[/caption]
Els M. Broens DVM, PhD, Dipl. ECVM, EBVS
European Veteirnary Specialist in Veterinary Microbiology
Associate Professor / Director VMDC
Department Biomolecular Health Sciences (Clinical Infectiology)
Faculty of Veterinary Medicine | Utrecht University
MedicalResearch.com: What is the background for this study?
Response: Several events have demonstrated that SARS-CoV-2 can infect animals, felines and mustelids in particular. In companion animals these are currently considered to be incidents with a negligible risk for public health since the main force of the pandemic is transmission between humans. However, it is urgent to understand the potential risk of animal infections for public health in the later stages of the pandemic when SARS-CoV-2 transmission between humans is greatly reduced and a virus reservoir in animals could become more important.
Incidental cases have shown that COVID-19 positive owners can transmit SARS-CoV-2 to their dog or cat. The close contact between owners and their dogs and cats and the interaction between dogs and cats from different households raises questions about the risk for pets to contract the disease and also about role of these animals in the transmission of SARS-CoV-2.
Scott Gray[/caption]
Scott Gray: Founder and CEO of Clincierge, the global leader in patient support services for clinical trials. With a team of patient coordinators around the world, Clincierge helps patients and their caregivers navigate the logistics of clinical trial participation, including prepaid air travel, ground transportation, and lodging as well as rapid reimbursements, translation and interpretation services, and individual solutions for trial participants in remote locations or with complex medical needs. For more information, visit clincierge.com.
MedicalResearch.com: What is the mission of Clincierge?
Background: To identify individual-level factors associated with COVID-19-related impacts on recovery in 216 participants originally enrolled in the SUBLOCADE® (buprenorphine extended-release) clinical program.
Within the fifteen-month study 216 participants, during the period of September 2021 through January 2021, were asked how the COVID-19 crisis affected their recovery from substance use, utilizing self-reported measures.
Dr. Begdache[/caption]
Lina Begdache, PhD, RDN, CDN, CNS-S, FAND
Assistant Professor
Health and Wellness Studies Department GW 15
Decker School of Nursing
Binghamton University
MedicalResearch.com: What is the background for this study?
Response: My research focuses on understanding the link between the modifiable risk factors (such as diet, sleep and exercise) and mental distress. In this study, adults of different age-groups (18 years and older) were followed for 4 weeks. Participants recorded their dietary intake, sleep quality, exercise frequency, their physical and mental wellbeing on a daily basis.
Another research interest of mine is to assess these factors in relation to sex (different brain morphology) and age-groups (based on brain maturity). The rationale of this categorization is that brain morphology and brain development vs maintenance and repair may require a different repertoire of food and environmental factors. Therefore, we also studied the sex and age-groups effect.
We also added the season factor as one of our
Dr. Nation[/caption]
Daniel A. Nation, Ph.D.,
Associate Professor of Psychological Science
Institute for Memory Impairments and Neurological Disorders
University of California, Irvin
MedicalResearch.com: What is the background for this study?
Response: Hypertension is a risk factor for cognitive decline and dementia, and treatment of hypertension has been linked to decreased risk for cognitive impairment.
Prior studies have attempted to identify which specific type of antihypertensive treatment conveys the most benefit for cognition, but findings have been mixed regarding this question. We hypothesized that antihypertensive drugs acting on the brain angiotensin system may convey the greatest benefit since they affect the brain angiotensin system that has been implicated in memory function.
Dr. Forbes[/caption]
Lisa Forbes, Ph.D, LPC, NCC
Clinical Assistant Professor
Counseling Program
University of Colorado Denver
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The most common mode of learning in tertiary education is lecture-based learning despite the knowledge that more active, engaged, and flexible approaches to teaching may better support the learning process. This study aimed to understand graduate students’ experiences with a playful pedagogy as an alternative approach to learning.
Dr. Seifi[/caption]
Ali Seifi, MD, FACP, FNCS, FCCM
Associate Professor
Director of Neuro Critical Care,
Fellowship Director, CAST Neurosurgery Critical Care
Department of Neurosurgery, Neurology, Anesthesiology and Medicine
The University of Texas Health Science Center at San Antonio
MedicalResearch.com: What is the background for this study?