Author Interviews, COVID -19 Coronavirus, Infections, UCSD / 13.03.2021

MedicalResearch.com Interview with: Abhishek Saha, PhD Assistant Professor Department of Mechanical and Aerospace Engineering University of California San Diego MedicalResearch.com: What is the background for this study? Response: At a very early stage of COVID 19 pandemic, the scientific community identified that respiratory droplet is the primary mode of transmission of the SARS-CoV2 virus. Naturally, the health agencies have encouraged facemasks to restrict these droplets from spreading during respiratory events, like coughing, sneezing, talking, etc. While WHO recommended using either N95 masks or other types of three-layer masks, due to a sharp increase in demand and scarcity in supplies, a variety of either home-made or locally purchased masks became popular. Naturally, one wonders if these single- and double-layer masks provide enough protection. To provide some insight into this critical question, our team, which also includes Professor Swetaprovo Chaudhuri from the University of Toronto, and Professor Saptarshi Basu of the Indian Institute of Science, experimentally analyzed what happens to the respiratory droplets when they impact single- and multi-layer masks.  (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Emory, JAMA, Occupational Health / 12.03.2021

MedicalResearch.com Interview with: Jesse T. Jacob, MD School of Medicine Director, Antibiotic Stewardship Program Emory University, Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: Since coronavirus disease 2019 (COVID-19) was recognized in the United States in January 2020, the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) attributed to exposures in the health care workplace has been studied with conflicting results, and the role of job functions (such as nurse) or specific workplace activities, including care for individuals with known and unknown SARS-CoV-2 positivity, increase the risk of SARS-CoV-2 infection. We assessed more than 24,000 healthcare providers between April and August 2020 across four large academic medical systems (Emory, Johns Hopkins, Rush University Medical Center, and University of Maryland) which collaborate in the CDC’s Prevention Epicenter Program and conduct innovative infection prevention research. Each site conducted voluntary COVID-19 antibody testing on its health care workers, as well as offered a questionnaire/survey on the employees’ occupational activities and possible exposures to individuals with COVID-19 infection both inside and outside the workplace. We also looked at three-digit residential zip-code prefixes to determine COVID-19 prevalence in communities.   (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, Kidney Disease, Yale / 11.03.2021

MedicalResearch.com Interview with: Jim Nugent, MD MPH Pediatric Nephrology Fellow Yale University School of Medicine MedicalResearch.com: What is the background for this study? Response: It is now well-established that acute kidney injury is common in patients hospitalized with COVID-19. In addition, patients with COVID-19 tend to have more severe acute kidney injury than patients who have acute kidney injury due to other causes. However, the intermediate and longer-term kidney outcomes after COVID-19-associated acute kidney injury have not yet been described. Our study compares the rate of change in estimated glomerular filtration rate after hospital discharge between patients with and without COVID-19 who experienced in-hospital acute kidney injury. Due to their more severe acute kidney injury in the hospital, we hypothesized that patients with COVID-19-associated acute kidney injury would have greater decline in kidney function after discharge compared to patients with acute kidney injury who tested negative for COVID-19. In order to answer this question, we reviewed the medical records of adult patients at 5 hospitals in Connecticut and Rhode Island admitted between March and August 2020 who had developed acute kidney injury during their hospitalization, survived until discharge, and were discharged off dialysis. For our study, we included patients who had at least one outpatient serum creatinine measurement after discharge. (more…)
Author Interviews, COVID -19 Coronavirus, Dermatology, JAMA / 11.03.2021

MedicalResearch.com Interview with: Jonathan Silverberg, MD, PHD, MPH Associate Professor Director of Clinical Research Director of Patch Testing George Washington University School of Medicine and Health Sciences Washington, DC MedicalResearch.com: What is the background for this study? Response: The COVID pandemic hit the Orthodox Jewish community in the United States particularly hard, especially in the early days when much was unknown. At that time of great loss, Jewish communities around the United States rallied to help the millions of other people impacted by the pandemic. A partnership was established of local community organizations across 5 states with premier academic universities across the United States and Canada. Over a 10 day period in May 2020, more than 6500 people came out to participate in the The Multi-Institutional Study Analyzing anti-CoV-2 Antibodies (MITZVA) cohort. Participants completed surveys and donated blood in order to become potential convalescent plasma donors and help learn more about the science of COVID. (more…)
Annals Internal Medicine, Author Interviews, COVID -19 Coronavirus, Tobacco, Tobacco Research, UCLA / 09.03.2021

MedicalResearch.com Interview with: Brian P. Lee, MD, MAS Assistant Professor Clinical Medicine University of Southern Californi Keck School of Medicine Los Angeles, California MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has been associated with mental health stressors, including anxiety, loneliness, and social instability. We hypothesized the pandemic may have led to increased alcohol and tobacco use as a coping mechanism for these stressors. National retrospective questionnaires had suggested higher reports of substance use, but these are limited by selection and recall biases, in addition to subjective report – we sought to address this knowledge gap by using a nationally-representative longitudinal cohort (Nielsen National Consumer Panel) tracking real-time purchases of households across the US.  (more…)
Author Interviews, Cost of Health Care, COVID -19 Coronavirus, Critical Care - Intensive Care - ICUs, JAMA / 05.03.2021

MedicalResearch.com Interview with: Ninh T. Nguyen, MD Chief of Gastrointestinal Division, Surgery UCI  MedicalResearch.com: What is the background for this study? What are the main findings  Response: There are limited national data on hospitalized patients in the US. To our knowledge, the current publication provides data on the largest cohort of COVID-19 patients hospitalized at US academic centers. (more…)
Author Interviews, Columbia, COVID -19 Coronavirus, Exercise - Fitness, Heart Disease, JAMA / 05.03.2021

MedicalResearch.com Interview with: David J. Engel, MD, FACC Division of Cardiology Columbia University Irving Medical Center New York, New York MedicalResearch.com: What is the background for this study? Response: ​​Early reports and observations in the COVID-19 pandemic found that patients recovering from mild to severe forms of COVID-19 illness had a higher prevalence of cardiac injury in comparison with what historically has been seen and reported with other viruses. This cardiac injury, categorized as inflammatory heart disease, could have serious implications, including a risk for exercise-triggered sudden cardiac death, for athletes and highly active people who have had prior COVID-19 illness and who return to intensive exercise activity with unknowing subclinical cardiac injury. To address these concerns in COVID positive athletes, the ACC generated return to play cardiac screening recommendations (troponin blood test, ECG, resting echocardiogram) for all competitive athletes after COVID-19 infection prior to resumption of competitive and intensive sport activity. The professional leagues were among the first organizations to return to full-scale sport activity in the setting of the pandemic, and they uniformly adopted and implemented the ACC return to play screening recommendations for all athletes that tested positive for COVID-19. The leagues recognized that there was value in collaborating and formally analyzing their pooled cardiac data, not only for league athlete health and safety purposes, but also to share broadly this information to add to the growing body of knowledge about the virus. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, Pediatrics, Pulmonary Disease / 04.03.2021

MedicalResearch.com Interview with: Dott.ssa Silvia Bloise MD Prof. Riccardo Lubrano MD PhD Pediatric and Neonatology Unit Maternal and Child Department Sapienza University of Rome Rome Italy MedicalResearch.com: What is the background for this study? Response: Pending new evidence, the universal facial masking, with other preventive measures remain the only strategies to limit the spread of SARS-CoV-2 infection. The use of face mask is particularly debated in the children, especially in younger children. Therefore, we wanted to test whether their in children was associated with episodes of desaturation or respiratory distress. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, COVID -19 Coronavirus, Electronic Records, JAMA, Technology / 04.03.2021

MedicalResearch.com Interview with: Carlo Giovanni Traverso, MB, BChir, PhD Associate Physician, Brigham and Women's Hospital Assistant Professor, Peter R. Chai, MD, MMS Emergency Medicine Physician and Medical Toxicologist Harvard Medical School Brigham and Women's Hospital Department of Medicine   Dr-Spot-HealthCare-Assistant.jpgMedicalResearch.com: What is the background for this study? What are some of the functions that Dr. Spot can facilitate? Response: During the COVID-19 pandemic, we wanted to consider innovative methods to provide additional social distance for physicians evaluating low acuity individuals who may have COVID-19 disease in the emergency department. While other health systems had instituted processes like evaluating patients from outside of emergency department rooms or calling patients to obtain a history, we considered the use of a mobile robotic system in collaboration with Boston Dynamics to provide telemedicine triage on an agile platform that could be navigated around a busy emergency department. Dr. Spot was built with a camera system to help an operator navigate it through an emergency department into a patient room where an on-board tablet would permit face-to-face triage and assessment of individuals. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity, Vaccine Studies / 03.03.2021

MedicalResearch.com Interview with: Laura M. Bogart, PhD Senior Behavioral Scientist RAND Corporation Santa Monica, CA 90407-2138 MedicalResearch.com: What is the background for this study? Response: Recent media polls continue to show that Black Americans are less likely to intend to get the COVID-19 vaccine than White Americans, and initial state data show a similar racial/ethnic disparity in vaccination rates. Initial uptake of the vaccine has been significantly affected by inequities in vaccine access and supply. In addition to these challenges, other factors contribute to hesitancy around vaccination, including self-perceived risk of infection, trust in the vaccine itself, trust in healthcare systems, healthcare providers, and policymakers who support the vaccine, and trust in the pharmaceutical industry and clinical research. In this study, we conducted a survey of a nationally representative sample of 207 Black Americans in late 2020, after initial COVID-19 vaccine effectiveness and safety data were released to the public. We also did in-depth interviews with a subsample of those surveyed who said that they would not get vaccinated. In addition, we engaged with a stakeholder advisory committee comprised of individuals who represent different subgroups and organizations in Black communities in the U.S., in order to discuss the results and make recommendations for policies to increase COVID-19 vaccination among Black Americans. (more…)
Author Interviews, COVID -19 Coronavirus, Heart Disease, Nature, Statins / 27.02.2021

MedicalResearch.com Interview with: Aakriti Gupta MD MS Fellow, Interventional Cardiology Columbia University Irving Medical Center NewYork-Presbyterian Hospital  MedicalResearch.com: What is the background for this study? Response: While taking care of patients with COVID-19 last spring and summer at the height of the pandemic, we observed that patients who got very sick and required hospitalization had high rates of hyperinflammation with elevated CRP levels, and thromboembolic phenomena. As cardiologists who frequently prescribe statins for hyperlipidemia, they were a class of drugs that came naturally to mind for their anti-inflammatory, anticoagulant and immunomodulatory properties in addition to their cholesterol lowering properties. As such, we decided to look at the association of statin use with in-hospital mortality in patients who are hospitalized with COVID-19. (more…)
Author Interviews, COVID -19 Coronavirus, Education, JAMA, UCLA / 22.02.2021

MedicalResearch.com Interview with: Frederick Zimmerman, PhD Professor, Department of Health Policy and Management Fielding School of Public Health UCLA   MedicalResearch.com: What is the background for this study? Response: The science on school transmissions of COVID is becoming clearer all the time in its conclusion that there is little to no transmission in school environments as long as reasonable precautions are taken.  Yet one recent study got a lot of attention for claiming that states that allowed their schools to remain open in the early days of the pandemic saw more cases.  That study did not control for several important factors that might explain this association, so our study aimed to correct that work. (more…)
Author Interviews, COVID -19 Coronavirus, Nature, Pediatrics / 19.02.2021

MedicalResearch.com Interview with: Dr Melanie Neeland PhD Research Fellow Murdoch Children's Research Institute Royal Children's Hospital Flemington Road, Parkville Victoria Australia  MedicalResearch.com: What is the background for this study? Response: Children generally have mild COVID-19 disease compared to adults, however the immune mechanisms underpinning this response are unclear. Understanding the underlying age-related differences in the severity of COVID-19 will provide important insights and opportunities for prevention and treatment of COVID-19. (more…)
Author Interviews, Blood Pressure - Hypertension, COVID -19 Coronavirus / 17.02.2021

MedicalResearch.com Interview with: Pam R. Taub, MD, FACC, FASPC Director of  Step Family Foundation Cardiovascular Rehabilitation and Wellness Center Associate Professor of Medicine UC San Diego Health System Division of Cardiovascular Medicine MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by postural orthostatic tachycardia syndrome?  Is it more common in patients who have incompletely recovered from a COVID-19 infection?  Response: Postural Orthostatic Tachycardia Syndrome (POTS) is a, complex multisystem clinical syndrome Patients experience a wide spectrum of symptoms of varying severity, which are often debilitating.  Upon assuming an upright standing position from being supine, patients experience an increase in heart rate by 30 beats per minute (bpm) from supine position, This is often accompanied by lightheadedness, palpitations, dyspnea, mental clouding (“brain fog”), headaches. POTS can occur after infections as it thought to be triggered by the immune system .  The hypothesis is that when the body is fighting an infection some of the antibodies it produces can attack our regulatory systems that control heart rate and blood pressure. We are seeing an increase in POTS cases occurring after COVID-19 infection.  These patient are referred to as the “long haulers” These long haulers have elevated heart rate, fatigue, brain fog and shortness of breath with activity consistent with POTS. We are seeing that  COVID-19 is another infection that can lead to POTS. Some articles on this https://www.thedenverchannel.com/news/national/coronavirus/some-covid-19-survivors-being-diagnosed-with-syndrome-called-pots (more…)
Author Interviews, COVID -19 Coronavirus / 16.02.2021

MedicalResearch.com Interview with: Rahul Subramanian PhD candidate Department of Ecology and Evolution Biological Sciences Division University of Chicago Chicago, IL 60637 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Understanding the proportion of COVID-19 cases that become symptomatic, as well as the extent to which people without symptoms contribute to COVID-19 transmission, has important public health implications. However, changes in PCR testing capacity over time have made these quantities hard to estimate precisely. We used a model that incorporates daily changes in PCR testing capacity, cases, and serology to precisely estimate the proportion of cases that were symptomatic in New York City during the initial wave of the outbreak. Only 1 in 7 to 1 in 5 cases were symptomatic. Furthermore, non-symptomatic cases of the virus (this includes people who are either pre-symptomatic or asymptomatic) substantially contribute to community transmission, making up at least 50% of the driving force of SARS-CoV-2 infection.  (more…)
Author Interviews, COVID -19 Coronavirus, Critical Care - Intensive Care - ICUs / 11.02.2021

MedicalResearch.com Interview with: Tejasvi Hora, PhD Candidate Department of Geography and Environmental Management, University of Waterloo Data Analyst, GEMINI, Unity Health Toronto MedicalResearch.com: What is the background for this study? Response: Death rates and resource use for COVID-19 hospitalization vary significantly worldwide, however, the characteristics and outcomes of COVID-19 hospitalizations in Canada have not been described in detail. Further, there is considerable uncertainty about how COVID-19 compares with influenza. In some circles, COVID-19 has been dismissed as being not more severe than “the flu”. ­We used data extracted from electronic health records of 7 hospitals in Ontario, Canada to describe characteristics and outcomes of hospitalization for COVID-19 and influenza.  (more…)
Author Interviews, CMAJ, COVID -19 Coronavirus, Kidney Disease / 05.02.2021

MedicalResearch.com Interview with: Peter G. Blake MD, FRCPC, FRCPI,MSc MB Professor of Medicine in the Division of Nephrology Ontario Renal Network University of Western Ontario and London Health Sciences Centre London, Ontario  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Covid-19 pandemic has been very difficult for people on dialysis with reports of high infection rates and high mortality. We prospectively collected data on SARS-CoV-2 infection every week from all renal programs in the province of Ontario, Canada from the start of the pandemic. Between March and August 2020, 187 people on dialysis, equivalent to 1.5% of all those in the province, were infected with the SARS-CoV-2 virus. Over 60% were hospitalized, 20% required ICU and the mortality rate was very high at over 28%. Risk factors for infection included center hemodialysis versus home dialysis, residing in long term care, black, south Asian and other non-white ethnicity, and low neighbourhood income. (more…)
Author Interviews, COVID -19 Coronavirus, Education, Race/Ethnic Diversity, Social Issues / 04.02.2021

MedicalResearch.com Interview with: Ankur Dalsania Rutgers New Jersey Medical School (NJMS) M.D. Candidate 2021 MedicalResearch.com: What is the background for this study? Response: Similar to past pandemics, prior studies and news articles have highlighted the disproportionate impact of COVID-19 mortality in marginalized populations, especially Black Americans. Rather than biological differences, other factors like neighborhood conditions, educational attainment, economic stability, healthcare access, and social contexts have been hypothesized to influence the racial disparities. Using county-level data, we sought to quantitatively determine how these factors, collectively referred to as social determinants of health, impact COVID-19 mortality in Black Americans.  (more…)
Author Interviews, Dengue, PLoS, Zika / 04.02.2021

MedicalResearch.com Interview with: Gregor J. Devine, Ph.D Mosquito Control LaboratoryQIMR Berghofer Medical Research Institute Brisbane, Queensland, Australia MedicalResearch.com: What is the background for this study? Scale of the problem: Dengue, Zika and chikungunya are all transmitted by the same mosquito species.  That mosquito, Aedes aegypti, is superbly adapted to the human, urban environment – it lays its eggs and develops in the standing water that collects in the myriad containers associated with modern living (plastic bottles, food packaging, buckets, planters, crumpled tarpaulins etc.). Unusually they rely almost entirely on human blood for their nutritional requirements and they subsequently bite multiple times during each egg laying cycle. That reliance on human blood means that they are usually found resting indoors, a behaviour that also offers them some protection from weather extremes and predators. Once infected, and having incubated the virus until it is transmissible, a mosquito that survives for just a couple of weeks can infect many humans within the same and neighbouring households. In poorer tropical urban environments with dense human populations, unscreened houses, no air-conditioning, and innumerable rain-filled containers to develop in, Aedes aegypti proliferates and so do those diseases, causing ca 400M annual infections of dengue alone by some estimates. The economic impact of the dengue, which normally causes a high fever, muscle and joint pains and nausea, is pronounced; especially in poor households with few savings and no welfare system. Every year, about 500,000 of those dengue cases develop into severe dengue, or dengue haemorrhagic fever (typified by plasma leakage, severe bleeding and organ impairment). There are about 25,000 deaths annually. mosquito-Aedes aegypti-feeding-human.jpgThe Zika pandemic of 2015-2016 resulted in 1000s of babies born with microcephaly and damage to their brains and eyes. For 1000s of other children, the impacts of Zika on their cognitive development did not manifest in their first, formative years.  Chikungunya is endemic in Asia and Africa but between 2010 and 2014, outbreaks and epidemics spread across the Indian Ocean, the Caribbean, the Americas and the Pacific Islands. It causes severe, often debilitating joint pain in infected patients. Those affected also suffer from headaches, fever, severe muscle pain and conjunctivitis. Joint pain can persist in subacute or chronic form for several months or even years, particularly in older patients. The ubiquity of the mosquito Aedes aegypti across the tropics and sub tropics ensures that further epidemics of Zika and chikungunya will occur, outside their usual ranges. It’s simply impossible to predict when that will occur. (more…)
Author Interviews, BMJ, COVID -19 Coronavirus, Gout, Rheumatology / 03.02.2021

MedicalResearch.com Interview with: Dr Rene Oliveira Department of Internal Medicine Ribeirao Preto Medical School University of Sao Paulo Ribeirao Preto, Brazil  MedicalResearch.com: What is the background for this study? Response: As rheumatologists our background for testing colchicine for COVID-19 was the effect of the drug on gout, Behçet's disease and familial Mediterranean fever. For these diseases, the drug is able to reduce systemic inflammation by acting in some cytokine pathways which the first reports in COVID-19 suggested being the same. We found that colchicine was able to reduce systemic inflammation and diminish the length of need for supplemental oxygen and hospitalisation. (more…)
Author Interviews, COVID -19 Coronavirus, Heart Disease, JAMA, Social Issues, University of Pennsylvania / 02.02.2021

MedicalResearch.com Interview with: Sameed Khatana MD, MPH Instructor, Cardiovascular Medicine Perelman School of Medicine, University of Pennsylvania Physician, Philadelphia VA Medical Center  MedicalResearch.com: What is the background for this study? Response: After declining for decades, the fall in cardiovascular mortality rates in the US has started to slow down and rates may be rising in certain groups. This stagnation in mortality has been most start among middle-aged adults. These trends have occurred at the same time as growing economic inequality. Our analysis aimed to study the relationship between change in cardiovascular mortality rates between 2010 and 2017 for middle-aged adults across the US and change in economic prosperity levels. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, COVID -19 Coronavirus, Prostate, Prostate Cancer, Surgical Research, Urology / 01.02.2021

MedicalResearch.com Interview with: David-Dan Nguyen Research Fellow | Center for Surgery and Public Health, Brigham and Women's Hospital MPH (Health Policy) Student | Harvard T.H. Chan School of Public Health Medical Student | McGill University MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has forced hospitals to delay the definitive treatment of cancers via surgery or radiation therapy. While previous evidence has shown that delaying the treatment of low-risk prostate cancer is not associated with worse outcomes, treatment delays for intermediate-risk and high-risk prostate cancer are more controversial. As such, we sought to determine if delays for these disease states negatively impacted oncological outcomes. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, Race/Ethnic Diversity, Social Issues / 29.01.2021

MedicalResearch.com Interview with: Renuka Tipirneni, MD, MSc, FACP Assistant Professor Holder of the Grace H. Elta MD Department of Internal Medicine Early Career Endowment Award 2019-2024 University of Michigan Department of Internal Medicine, Divisions of General Medicine and Hospital Medicine, and Institute for Healthcare Policy & Innovation Ann Arbor, MI MedicalResearch.com: What is the background for this study? Response: As there have been significant racial/ethnic disparities in US COVID-19 infections and health outcomes including death, we investigated county-level social factors that may explain these inequities. Specifically, we examined the association between the Centers for Disease Control and Prevention’s Social Vulnerability Index (a composite measure of social disadvantage) and COVID-19 incidence and mortality rates. We found that with just a one-point increase in the ten-point scale, there was a 14% increase in incidence rate and 14% increase in mortality rate. This equated to approximately 87 excess COVID-19 infections and 3 deaths per 100,000 population.  (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 25.01.2021

MedicalResearch.com Interview with: Marlene Cano MD. PhD. Post-Doctoral Research Fellow in Pulmonary Transplant Immunology Division of Pulmonary and Critical Care Department of Medicine Washington University/Barnes-Jewish Hospital Saint Louis, MO MedicalResearch.com: What is the background for this study? How does this test differ from other tests for COVID-19?   Response: We know COVID-19 causes a wide spectrum of disease, and that while many develop only mild uncomplicated illness, others develop severe respiratory failure, multi-organ failure and death. These patients often require prolonged hospitalization, ICU level care and even mechanical intubation for respiratory support. However, we still do not have a great way to identify which patients are likely to develop severe disease. We felt it was important to have a test that could act as sort of a ‘biomarker’ that we could measure early in COVID-19 patients and would help predict which patients would develop severe disease. From prior work, we knew that mitochondrial DNA, which are proinflammatory molecules that are released into the circulation from damaged organs could be this such ‘biomarker’. So, we measured the levels of mitochondrial DNA circulating in the plasma of patients with COVID-19 at the time they first presented to the hospital. Then we investigated if higher levels of mitochondrial DNA indeed predict the development of more severe disease. Currently there are no ‘biomarker’ tests specific for COVID-19. We do currently measure levels of other markers in the hospital that we feel might help us assess overall how sick patients may be, but these are very non-specific and assess only level of inflammation. This test instead can measure level of tissue injury. (more…)
Author Interviews, Infections, OBGYNE, Pharmaceutical Companies / 21.01.2021

MedicalResearch.com interview with: Dr. Stephen Brand, Chief Development Officer Mycovia Pharmaceuticals  Dr. Stephen Brand discusses the results of Mycovia’s three Phase 3 studies for recurrent vaginal yeast infections (RVVC )and what’s next for the company.  MedicalResearch.com: What is the background for these Phase 3 studies? Answer: Our Phase 3 clinical program for our oral therapy oteseconazole was comprised of three trials enrolling more than 870 patients at 176 sites across 11 different countries. Two of these trials, referred to as VIOLET were identical Phase 3 randomized, double-blind, placebo-controlled clinical trials to evaluate the safety of oteseconazole and its ability to prevent episodes of recurrent vulvovaginal candidiasis (RVVC), commonly referred to as chronic yeast infection. The trials took place over 48 weeks in subjects with an established disease history of at least three episodes of acute VVC in the past 12 months. More than 650 patients randomized at 125 sites across 11 countries. The VIOLET trials consisted of two parts: During the first part of the study which lasted two weeks after patients presented with an active VVC episode, patients were treated with three sequential 150mg doses of fluconazole. The second part consisted of 12 weeks, when the patient either took oteseconazole 150mg or a placebo once weekly (according to a random assignment), and then a 36-week follow-up period. In addition, subjects participating in the VIOLET trials in the U.S. who remained infection-free at their Week 48 visit were offered the opportunity to participate in an extension study and are being monitored for an additional 48 weeks to further define the long-term protection profile of oteseconazole. Eighty-five subjects are enrolled. The third Phase 3 study, called ultraVIOLET, was designed to complement and extend VIOLET as a 50-week randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of oteseconazole. In addition the study compared the effectiveness of oteseconazole compared to fluconazole, the current standard of care, to treat an acute VVC infection in the RVVC population. A total of 220 patients were randomized at 51 sites in the U.S. for the ultraVIOLET trial. The ultraVIOLET trial consisted of two parts: In the first part of the study RVVC subjects presenting with an active infection were randomized to receive either 2 days of dosing with oteseconazole or 3 sequential 150 mg doses of fluconazole (every 72 hours). The second part consisted of 11 weeks, when the patient took either oteseconazole or a placebo weekly (according to the random assignment from the first part of the study), and then a 37-week follow-up period. (more…)
Author Interviews, COVID -19 Coronavirus / 20.01.2021

MedicalResearch.com Interview with: Dr Caroline Wei Shan Hoong, MBBS, MRCP Associate Consultant Endocrinologist Department of General Medicine Woodlands Health Campus National Healthcare Group, Singapore MedicalResearch.com: What is the background for this study? Response: In the course of our clinical work, we have noticed a predominance of musculoskeletal complaints among some of COVID-19 patients who are otherwise clinically well, and a small subset of them who develop a viral arthralgia (joint pains) sometimes occurring separately from the onset of acute respiratory symptoms. Besides a few isolated case reports, there was not much described about COVID-19 associated viral arthralgia in the literature. Clinicians are well aware of the need to test for COVID-19 when patients present with cough or shortness of breath. However, when they present as joint pains without any respiratory symptoms, a diagnosis of COVID-19 could easily be missed. Due to overlapping clinical features like low platelet count and elevated liver enzymes, they could easily be misdiagnosed as having other vector-borne infections such as dengue fever, if clinicians do not have a high clinical suspicion of COVID-19. Hence we decided to describe the epidemiology and various presentations of musculoskeletal manifestations of COVID-19 in our cohort of patients.  (more…)
Author Interviews, COVID -19 Coronavirus, Diabetes, Race/Ethnic Diversity / 16.01.2021

MedicalResearch.com Interview with: Anath Shalev, M.D. Professor of Medicine Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research Director, Comprehensive Diabetes Center University of Alabama at Birmingham Birmingham, AL  MedicalResearch.com: What is the background for this study?  What is metformin normally prescribed for? Response: Diabetes has been recognized as one of the major comorbidities associated with higher mortality in the context of the spreading COVID-19 pandemic, but ways to improve outcome in this at-risk population are lacking. Metformin is the most common medication used for type 2 diabetes. In addition, it is sometimes prescribed to people with prediabetes or to women with polycystic ovary syndrome (PCOS). (more…)
Author Interviews, COVID -19 Coronavirus, Critical Care - Intensive Care - ICUs, Pulmonary Disease / 15.01.2021

MedicalResearch.com Interview with: Dr Andrew Conway Morris Wellcome Trust Clinical Research Career Development Fellow University of Cambridge Hon Consultant in Intensive Care Medicine Addenbrookes Hospital, Cambridge MedicalResearch.com: What is the background for this study? Response: Patients with COVID-19 frequently need to come to the intensive care unit (ICU), where we use mechanical ventilation to support their lungs as they get over the intense inflammation caused by the virus.  During the first wave of the virus we noted that a lot of our patients appeared to be developing secondary infections (infections they didn’t have when they came into the ICU). We therefore rolled out a rapid diagnostic test for these secondary bacterial infections that we had developed previously, and this study reports the use of this diagnostic and also describes the types of bacteria seen.  To see if the increase in secondary infections was due to COVID specifically, we compared them to patients who were managed in the same ICU but who did not have COVID. (more…)
Author Interviews, COVID -19 Coronavirus, Mental Health Research, Race/Ethnic Diversity, Social Issues, UCSF / 15.01.2021

MedicalResearch.com Interview with: Jason Nagata, MD, MSc Assistant Professor of Pediatrics University of California, San Francisco San Francisco, California MedicalResearch.com: What is the background for this study? Response: Food insecurity is the inability to afford or access nutritionally adequate and safe foods for an active, healthy lifestyle. Rates of food insecurity were projected to rise during the COVID-19 pandemic; however, prior studies had not examined the association between food insufficiency, the most extreme form of food insecurity, and mental health. MedicalResearch.com: What are the main findings? Response: Using a large national sample of nearly 64,000 adults, we found that food insufficiency rose from 8.1% to 10.0% during the pandemic. People of color and younger adults had higher risk of food insufficiency. People living in poverty or experiencing recent job loss were at higher risk of food insufficiency. Food insufficiency was associated with symptoms of anxiety, worrying, and depression. Hunger, exhaustion, and worrying about not getting enough food to eat may worsen depression and anxiety symptoms. Receiving food assistance alleviated the relationship between food insufficiency and poor mental health.   (more…)
Author Interviews, COVID -19 Coronavirus, Pulmonary Disease / 12.01.2021

MedicalResearch.com Interview with: Dr. Liam Townsend, PhD Department of Infectious Diseases St. James's Hospital and Department of Clinical Medicine Trinity Translational Medicine Institute Trinity College, Dublin, Ireland  MedicalResearch.com: What is the background for this study? Response: Much is known about the clinical characteristics and pathological features of acute SARS-CoV-2 infection, but there is relatively little known about post-COVID recovery. This has come under increasing scrutiny in light of reports that patients suffer persistent symptoms beyond resolution of initial infection, known as long COVID. We set out to assess patients in our post-COVID clinic for ongoing ill-health, with particular focus on fatigue and breathlessness. Given that COVID-19 primarily affects the respiratory system, we also evaluated respiratory recovery. Patients underwent chest radiography and six-minute-walk testing, as well as routine blood tests including inflammatory markers and D-dimers. We included both patients who were admitted during their acute infection as well as those managed in the community in order to capture the full spectrum of disease. (more…)