Author Interviews, COVID -19 Coronavirus, Critical Care - Intensive Care - ICUs, JAMA / 13.12.2021
COVID-19: Study Finds Changes in Convalescent Plasma Efficacy Over Time
MedicalResearch.com Interview with:
[caption id="attachment_58516" align="alignleft" width="150"]
Dr. Pirofski[/caption]
Liise-anne Pirofski, M.D.
Mitrani Professor of Biomedical Research
Chief, Division of Infectious Diseases
Albert Einstein College of Medicine and
Montefiore Medical Center
Liise-anne Pirofski, MD on behalf of lead authors Mila Ortigoza MD, PhD, Assistant professor at NYU Langone Health and Hyunah Yoon MD, Assistant Professor, Albert Einstein Medical Center
and the CONTAIN COVID-19 trial authors and team
MedicalResearch.com: What is the background for this study?
Response: The study was designed to determine the efficacy of COVID-19 convalescent plasma (CCP) in hospitalized patients with COVID-19. It was designed and launched in New York City in April 2020 during the height of the first COVID-19 pandemic wave and later extended to sites in Miami, Houston, and other regions affected by subsequent waves of the pandemic. At that time, there were no validated therapeutic options for COVID-19, and there was clinical equipoise for CCP use in hospitalized patients. COVID-19 convalescent plasma was considered worthy of investigation because of the historical success of convalescent plasma in prior pandemics and epidemics dating to the beginning of the 20th century, and importantly, biological plausibility because convalescent plasma contains antibodies to agents from which people have recovered, and case series and observational studies showing signals of CCP efficacy in patients with COVID-19. The trial was designed to focus on patients with moderate to severe COVID-19 who required supplemental oxygen, but not mechanical intubation. At the time the trial was designed, hospitals in New York City were overwhelmed with severely and critically ill patients with COVID-19, an entirely new disease about which more and more was learned over the 11 months the trial was conducted.
Dr. Pirofski[/caption]
Liise-anne Pirofski, M.D.
Mitrani Professor of Biomedical Research
Chief, Division of Infectious Diseases
Albert Einstein College of Medicine and
Montefiore Medical Center
Liise-anne Pirofski, MD on behalf of lead authors Mila Ortigoza MD, PhD, Assistant professor at NYU Langone Health and Hyunah Yoon MD, Assistant Professor, Albert Einstein Medical Center
and the CONTAIN COVID-19 trial authors and team
MedicalResearch.com: What is the background for this study?
Response: The study was designed to determine the efficacy of COVID-19 convalescent plasma (CCP) in hospitalized patients with COVID-19. It was designed and launched in New York City in April 2020 during the height of the first COVID-19 pandemic wave and later extended to sites in Miami, Houston, and other regions affected by subsequent waves of the pandemic. At that time, there were no validated therapeutic options for COVID-19, and there was clinical equipoise for CCP use in hospitalized patients. COVID-19 convalescent plasma was considered worthy of investigation because of the historical success of convalescent plasma in prior pandemics and epidemics dating to the beginning of the 20th century, and importantly, biological plausibility because convalescent plasma contains antibodies to agents from which people have recovered, and case series and observational studies showing signals of CCP efficacy in patients with COVID-19. The trial was designed to focus on patients with moderate to severe COVID-19 who required supplemental oxygen, but not mechanical intubation. At the time the trial was designed, hospitals in New York City were overwhelmed with severely and critically ill patients with COVID-19, an entirely new disease about which more and more was learned over the 11 months the trial was conducted.
Dr. Lee[/caption]
Cecilia S. Lee, MD, MS
Associate Professor,Director, Clinical Research
Department of Ophthalmology
Harborview Medical Center
University of Washington Seattle, WA
MedicalResearch.com: What is the background for this study?
Response: Cataract is a natural aging process of the eye and affects the majority of older adults who are at risk for dementia. Sensory loss, including vision and hearing, is of interest to the research community as a possible risk factor for dementia, and also as a potential point of intervention. Because cataract surgery improves visual function, we hypothesized that older people who undergo cataract surgery may have a decreased risk of developing Alzheimer disease and dementia.
We used the longitudinal data from an ongoing, prospective, community based cohort, Adult Changes in Thought (ACT) study. The ACT study includes over 5000 participants to date who are dementia free at recruitment and followed until they develop Alzheimer disease or dementia. We had access to their extensive medical history including comprehensive ophthalmology visit data. We investigated whether cataract surgery was associated with a decreased risk of developing Alzheimer disease and dementia.
Dr. Dalton[/caption]
Kristine Dalton PhD FAAO, FBCLA
School of Optometry & Vision Science
University of Waterloo
Waterloo, Canada
MedicalResearch.com: What is the background for this study?
Response: Dynamic visual acuity refers to the ability to detect and perceive small details in objects that are moving relative to an observer. Dynamic visual acuity is a complex visual function, that involves a number of different aspects of vision, including detecting the target, moving the eyes appropriately to observe the target, and processing the visual information from the target in the brain to interpret what we are seeing. What makes dynamic visual acuity so interesting to study, is that as a visual function, it appears to play an important role in a number of real-world situations, including playing sports, driving, and piloting, and it may provide us more information about how the visual system is functioning compared to the more traditional, static vision tests alone.
Previous research has demonstrated that consumption of caffeine has been shown to benefit physiological, psychomotor, and cognitive performance. More recently there has been an increased interest in studying the impacts of caffeine on the vision system, however the impact of caffeine on dynamic visual acuity has not been studied. This study was designed to address this limitation in the literature, particularly because dynamic visual acuity appears to be such an important visual function for real-world activities.
Dr. Dickerman[/caption]
Dr. Barbra Dickerman, PhD
CAUSALab investigator and instructor
Department of Epidemiology
Harvard T.H. Chan School of Public Health
MedicalResearch.com: What is the background for this study?
Response: Early randomized trials showed that the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines were both remarkably effective at preventing symptomatic disease, when comparing each vaccine with no vaccine. However, head-to-head comparisons of these vaccines have been lacking, leaving open the question of which vaccine is more effective.
In this study, we analyzed the VA’s high-quality databases in a way that emulated the design of the hypothetical trial that would have answered this question. Specifically, we used the findings from the original trials to benchmark our methods and then extended them to provide novel evidence for the comparative effectiveness of these two vaccines in a real-world setting and across diverse subgroups and different time periods.
Dr. Woodruff[/caption]
Carina M. Woodruff, MD
Department of Dermatolog
University of California, San Francisco
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Rigorous hand hygiene has been an important component of the CDC's COVID-19 guidelines. With millions of Americans now using hand sanitizers regularly, we are seeing many more cases of hand dermatitis. Our study evaluated the key product features and most common allergens in the top-reviewed, commercial hand sanitizers sold by major US retailers.
We found that the most common potential allergens were tocopherol, fragrance, propylene glycol and phenoxyethanol. Our study also showed that nearly 1 in 5 marketing claims on these products was misleading. For example, 70% of sanitizers with the marketing claim "hypoallergenic" included at least one common allergen in its formulation.
Dr. Israel[/caption]
Ariel Israel, M.D., Ph.D.
Director, Leumit Health Services
Tel Aviv, Israel
MedicalResearch.com: What is the background for this study?
Response: As a research institute of Leumit, one of the four state mandated health funds in Israel, we pursue research projects aimed at improving the health of our members, and reducing the burden of disease. For this purpose, we harness the unique resource of the electronic health records of our members, that is available in a central data warehouse for research purposes.
Israel was one of the first countries to roll-out a large-scale vaccination campaign, and to achieve control of the pandemics through vaccination. Nevertheless, since the middle of June '21, we have observed a gradual increase in the rate of COVID-19 infections among our members, even among the vaccinated. This increase was first believed to be due to the emergence of the delta strain, but when we compared vaccinated individuals who suffered from breakthrough infections to other vaccinated individuals, we found that the time that has elapsed since vaccination was significantly longer for individuals who got infected with COVID-19, in each of the age groups.
This prompted us to investigate the issue of a possible waning effect of the vaccine protection with time, that we present in this report, using the test negative study design.
We examined the electronic health records for 80,057 adults (average age 44 years) who received a PCR test at least three weeks after their second injection, and had no evidence of previous covid-19 infection. Of these 80,057 participants, 7,973 (9.6%) had a positive test result. These individuals were then matched to negative controls of the same age and ethnic group who were tested in the same week.
Dr. Ashwin Nathan[/caption]
Ashwin Nathan, MD, MSHP
Assistant Professor, Medicine, Perelman School of Medicine
Interventional Cardiologist
Hospital of the University of Pennsylvania and at the
Corporal Michael C. Crescenz VA Medical Center in Philadelphia
Penn Cardiovascular Outcomes, Quality & Evaluative Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We found that the rates of TAVR were lower in areas with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients. Inequities in access in areas with higher proportions of Black and Hispanic patients existed despite adjusting for socioeconomic status.
Kelly Gavigan[/caption]
Kelly Gavigan, MPH
Manager, Research and Data Science
Dr. Howard[/caption]
Jeffrey Howard, PhD
Associate Professor
Department of Public Health
College for Health, Community and Policy
University of Texas at San Antonio
MedicalResearch.com: What is the background for this study?
Response: Drug and alcohol related mortality has been on the rise in the US for the past decade, which has drawn a lot of focus from researchers. At the same time maternal mortality, deaths caused by pregnancy complications, is recognized to be higher in the US than in other developed nations.
Very little has been reported about deaths among pregnant and recently pregnant women that are not caused by pregnancy complications, so my collaborators and I wanted to explore this. We did not anticipate that drug and alcohol deaths and homicides would account for so many deaths among pregnant and recently pregnant women.