Measuring Deaths and Long-Term Effects, Questions About Russian Vaccine, Citizen Scientists Making Their Own: COVID-19 Updates

September 18, 2020 | COVID-19 will become seasonal (eventually), mental effects on children and pregnant women, gaps in vaccine interest, what’s behind disparities, a test to identify plasma donors, better way to measure deaths, thousands could have lasting nerve damage, what does and doesn’t put people at higher risk, reasons for rehospitalization, potential shortening of life expectancy, azithromycin okay by itself, and researchers question Russian vaccine while citizen scientists experiment with DIY ones. Plus, a backlog in oncology, AI put to work and seven digital health solutions get NIH funding.

 

Research Updates

 Although most vaccine developers are shooting for a robust antibody response to neutralize the virus and are focusing on the spike protein as the immunizing antigen, compelling evidence shows that the approach is problematic, a University of California – Berkeley researcher argues in a review article that published in Vaccine X. A better strategy is to take a lesson from one of the world's best vaccines, the 82-year-old yellow fever vaccine, which stimulates a long-lasting, protective T-cell response. Clinical research should look at the responses of T-cells during phase 2 trials and correlate them with who does well or not over the next several months to get a good sense of the laboratory features of vaccines that work. A technique developed in the author’s UC Berkeley lab can assess the lifespan of T-cells to tell within three or four months whether a specific vaccine will provide long-lasting cells and durable T-cell-mediated protection. DOI: 10.1016/j.jvacx.2020.100076 

A review published in Frontiers in Public Health by researchers from the American University of Beirut in Lebanon and Qatar University in Doha suggests that COVID-19 will likely follow the seasonal patterns of some respiratory viruses in countries with temperate climates, but only when herd immunity is attained. The authors examined the viral and host factors that control the seasonality of influenza and several types of coronaviruses that cause the common cold, as well as the latest knowledge on the stability and transmission of SARS-CoV-2. They also note that people's susceptibility to infections and human behaviors, such as indoor crowding, differ across the seasons due to changes in temperature and humidity. These factors influence transmission of respiratory viruses at different times of the year.; COVID-19, however, has a higher rate of transmission due partly to its circulation in a largely immunologically naïve population. DOI: 10.3389/fpubh.2020.567184 

An ongoing longitudinal study suggests that lengthy school closures owing to the COVID-19 lockdown has had significant mental health effects on children and adolescents in China. The preliminary findings are consistent with a recent systematic review suggesting the association between enforced social isolation imposed by disease containment measures with future mental health problems among young people. A total of 1,241 students participated in both waves of the survey, generating data on depressive and anxious symptoms, nonsuicidal self-injury, suicide ideation, suicide plan, and suicide attempt. DOI: 10.1001/jamanetworkopen.2020.21482

In JAMA Pediatrics, researchers in Italy report on a case-control study comparing the rate of test results indicating SARS-CoV-2 infection among children (about 1% among 881 individuals) and adults (9% among 3,610 individuals) admitted to a single hospital in Milan for noninfectious reasons and without COVID-19 symptoms between March 1 and April 30, 2020. The role of children as facilitators of the spreading of SARS-CoV-2 infection could be reconsidered, they conclude. DOI: 10.1001/jamapediatrics.2020.3595

Almost seven in 10 Americans would be interested in receiving a COVID-19 vaccine when one becomes available, but there are concerning gaps in interest—particularly among Black Americans, who suffer disproportionately from the virus. Researchers from The Ohio State University surveyed 2,006 Americans in May, asking them about their willingness to be vaccinated and 11 factors that could influence that decision, and 69% said they would "definitely" or "probably" get a vaccine. But among black survey respondents, only 55% said they were willing to get a vaccine. One of the more unexpected findings of the study is the correlation between political affiliation and willingness to adopt a public health intervention, with respondents who identified as liberal or moderate being significantly more likely to accept a vaccine. Only 35% of participants said they’d would pay $50 or more out-of-pocket for a COVID-19 vaccine. The study, appearing online in Vaccine, is one of the first estimates of COVID-19 vaccine acceptance in the U.S. DOI: 10.1016/j.vaccine.2020.08.043

A study appearing in the Journal of Clinical Nursing has found fear and depression were commonplace among 331 pregnant women in China during the COVID-19 outbreak. Participants completing an online questionnaire said they were most worried about "potential infected people were unprotected and non-isolated" (83.1%), "self-infection could affect the health of their baby" (78.6%) and "they themselves becoming infected and being isolated" (56.2%). Women's psychological responses to the COVID-19 outbreak increased pregnancy stress, whereas their sense of security decreased pregnancy stress. DOI: 10.1111/jocn.15460 

Significantly higher nasal expression of transmembrane serine protease 2 (TMPRSS2) may partially contribute to COVID-19 risk among blacks, suggests a study by Mount Sinai researchers that published in JAMA. Blacks have experienced rates of infection and death that in some areas are twice or three times more than their proportion of the population. The retrospective analysis drew on a cross-sectional study of 305 patients of diverse racial/ethnic backgrounds, ages 4-60, within the Mount Sinai Health System, from whom nasal samples were collected. The critical importance of including diverse participants in clinical trials, particularly those of TMPRSS2 inhibitors, was one of the key takeaways of the findings. DOI: 10.1001/jama.2020.17386

Compared to those still working or absent with other illness or disabilities in mid-May, adults home sick with COVID-19 had lower incomes, were more likely to be racial/ethnic minorities, and had less education—national-level evidence of the disparate impact of the COVID-19 pandemic that bolsters other studies based on diagnosed cases and deaths, findings a study by researchers at Harvard Medical School that published in the Journal of General Internal Medicine. An additional finding was that these adults had very high rates of being uninsured (29.2%) and having food insecurity (36.2%) that could compound the health harms of the pandemic. Data came from the Census Bureau's Household Pulse Survey during two weeks in April and May. Researchers say the disparate impact on COVID-19 is larger than what has been measured by means of diagnoses and deaths because many people recover at home without ever being tested. DOI: 10.1007/s11606-020-06159-5

A study published in The Journal of Clinical Investigation reports on an antibody test for SARS-CoV-2 that is more accurate and can handle a much larger number of donor samples at lower overall cost than standard antibody tests currently in use. The easy-to-perform ELISA test was developed by researchers at the University of Texas at Austin in collaboration with Houston Methodist, Penn State University and the U.S. Army Medical Research Institute of Infectious Diseases. The study used the assay to evaluate 2,814 blood samples from an ongoing study of convalescent plasma therapy and concluded that anti- receptor binding domain or anti-ectodomain antibody levels can serve as a surrogate for virus neutralizing levels to identify suitable plasma donors and that these alternate ELISA tests may provide critical information about COVID-19 immunity. In the near term, the test can be used to accurately identify the best donors for convalescent plasma therapy and measure how well candidate vaccines and other therapies elicit an immune response. Additional uses coming later that are likely to have the biggest societal impact, the researchers say, are to assess relative immunity in those previously infected by the SARS-CoV-2 virus and identify asymptomatic individuals with high levels of neutralizing antibodies against the virus. DOI: 10.1172/JCI141206 

Researchers from Stanford University School of Medicine, Dana-Farber Cancer Institute, Harvard T.H. Chan School of Public Health, and Harvard Medical School offer suggestions for addressing challenges associated with measuring direct and indirect deaths attributable to the COVID-19 pandemic in the Annals of Internal Medicine. Estimating deaths based on death certificate data significantly underestimates the true mortality rate, they say. Their proposed methodology involves measuring direct, indirect, and excess deaths from COVID-19. That means counting all deaths from pneumonia, influenza-like illness, and COVID-19 and subtracting the expected seasonal number of cases of pneumonia and influenza computed from trends in the previous five years. To calculate indirect deaths, they recommend employing the CDC's "but for" principle that is used when ascertaining disaster-related deaths and, for excess deaths, using publicly available and well-curated historical data with published application programming interfaces. DOI: 10.7326/M20-3100

COVID-19 patients on ventilators placed in a prone position to make it easier for them to breathe and more likely to survive may end up with permanent nerve damage, according to a study by researchers at Shirley Ryan AbilityLab and Northwestern University Feinberg School of Medicine that has been accepted for publication in the British Journal of Anaesthesia. Scientists believe the nerve damage is the result of reduced blood flow and inflammation. Other non-COVID-19 patients on ventilators in this position rarely experience any nerve damage. Based on this study and another that subsequently came out, 12% to 15% percent of the most severely ill COVID-19 patients have permanent nerve damage. Worldwide, potentially thousands of patients have been impacted, the authors say. The most common injuries are wrist drops, foot drops, loss of hand function and frozen shoulder—up to four distinct nerve injury sites per patient—and some people who are dragging a foot need assistance with walking. Patients with pre-existing conditions that interfere with nerve regeneration, such as diabetes mellitus, are less likely to recover full function. As a result of the findings, physicians are modifying the prone position protocol for COVID-19 patients at Northwestern Memorial Hospital. These include adjustments to the way joints are positioned as well as extra padding under patients’ elbows and knees. DOI: 10.1101/2020.07.01.20144436

Patients on immunosuppressive therapy for common skin and rheumatic diseases like psoriasis and rheumatoid arthritis are not at increased risk for contracting COVID-19 and should continue taking their medicine as prescribed, according to Henry Ford Health System researchers in a study that published in the Journal of the American Academy of Dermatology. The study is one of the first to analyze the association between immunosuppressive medications for skin diseases and the risk of COVID-19 infection and outcomes. In a retrospective analysis of 213 patients being treated for an immune-mediated inflammatory disease and tested for COVID-19 between Feb. 1 and April 18, 36% tested positive and had no greater odds of being hospitalized or placed on a ventilator than the general population. There was no evidence that any single immunosuppressive medication increased the odds of testing positive or developing serious disease; conversely, patients on multidrug therapy regimens were at greater odds of being hospitalized. Patients prescribed a TNF alpha inhibitor, used to stop inflammation, had significantly lower odds for hospitalization. DOI: 10.1016/j.jaad.2020.07.089

A study funded by the National Institutes of Health that published in Molecular Psychiatry has found that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. Researchers analyzed the electronic health records (EHR) of millions of patients in the U.S., revealing that individuals with an SUD constituted 10.3% of the total study population but 15.6% of the COVID-19 cases. Among other findings were that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death) than people without an SUD. EHR data was collected until June 15, 2020 from 360 hospitals nationwide. The study population consisted of over 73 million patients, of which over 7.5 million had been diagnosed with an SUD at some point in their lives. Slightly more than 12,000 were diagnosed with COVID-19, and about 1,880 had both an SUD and a COVID-19 diagnosis on record. DOI: 10.1038/s41380-020-00880-7

In a Viewpoint published in JAMA Pediatrics, doctors from the University of Washinton School of Medicine and the University of Chicago say too little is known about the performance of any of the candidate COVID-19 vaccines or the epidemiology of SARS-CoV-2 in children to make any firm judgments about whether a COVID-19 vaccine should be mandatory in children. The basis of their conclusion are nine standard criteria used to determine whether a vaccine should be mandated for children, with priority given to five of them: evidence of safety with an acceptable level of risk; burden of COVID-19 disease ought to be substantial in at least a subset of the population; vaccinating children should reduce the risk of transmission of disease; the COVID-19 vaccine must also be effective in protecting a child from the disease; and it should not be burdensome for a child’s parent or guardian to comply with the vaccine mandate. They propose that the criteria be integrated into planning to help ensure the right decision is made. DOI: 10.1001/jamapediatrics.2020.3019

Efforts to stem the impact of COVID-19 in low to middle income countries (e.g., quarantining and restricting travel) could be creating a health time bomb in their slum communities by deepening existing inequalities, according to an international team of health researchers led by the University of Warwick (U.K.). Adoption of mobile consulting and upskilling local providers could be an effective way to provide access to healthcare services for residents, they say. Their study was published in BMJ Global Health and conclusions were drawn from research with community leaders, residents, health workers, volunteers and managers working on the ground in slum communities of Bangladesh, Kenya, Nigeria and Pakistan. Due to the disruption in health services, residents were turning more frequently to home remedies, pharmacies or patent medicine vendors, and traditional healers. Some of these providers are in a good position to advise residents and direct them to formal healthcare when it is in the patient's best interest and should be supported in doing this. DOI: 10.1136/bmjgh-2020-003042

The COVID-19 pandemic could cause a short-term decline in life expectancy in many regions of the world, according to an analysis of period life expectancy (number of years that an average person may expect to live) that published in PLOS ONE. The study, led by International Institute for Applied Systems Analysis (IIASA, Austria), examined the impact of COVID-19-related deaths on life expectancy for four broad world regions across multiple rates of infection and age groups. Researchers built a model that simulates the probability of getting infected by COVID-19, the probability of dying from it, and the probability of dying from another cause for a period of one year, taking into account the different fatality rates from the disease for different age groups. They then calculated the impact of COVID-19 on life expectancy by reconstructing life tables and life expectancies from the simulation and comparing them with those used for the inputs. At prevalence rates of only 2%, they say, COVID-19 could cause a drop in life expectancy in countries where average life expectancy is high. At higher prevalence rates, the impact on life expectancy would be greater, especially in Europe and North America. DOI: 10.1371/journal.pone.0238678

Roughly 1 in 10 patients diagnosed with COVID-19 needed to return to the hospital within a week of discharge from an emergency department (ED) visit, according to data from the first three months of the COVID-19 outbreak in the Philadelphia region. Researchers in the Perelman School of Medicine at the University of Pennsylvania also found that factors like lower pulse oximetry levels and fever were some of the most telling symptoms that resulted in return trips that resulted in admission. Other factors, such as an abnormal chest x-ray, further raised the risk of return and admission. The study looked at 1,419 patients who went to an ED between March 1 and May 28, 2020, were discharged, and tested positive for COVID-19 in the seven days surrounding that visit. Data showed that 4.7% of the patients returned to the hospital and were admitted within just three days of their initial ED visit, and an additional 3.9% were hospitalized within a week. Patients over 60 years old were particularly vulnerable. Findings published in Academic Emergency Medicine. DOI: 10.1111/acem.14117 

An international team of researchers has implemented COVID-NMA Project, an "evidence ecosystem" for COVID-19-related studies that minimizes multiple low-quality reviews and helps connect evidence generation, synthesis, and decision-making. The ecosystem consists of living mapping of all trials and a comprehensive living synthesis of all available trial evidence evaluating the effect of interventions for the prevention or treatment of COVID-19. There is a master protocol and subprotocols dedicated to specific questions, which are discussed and agreed on by a steering committee. A search to identify eligible randomized controlled trials is performed daily. As soon any trial with results is identified, data are collected, risk of bias fully assessed, and forest plots of appropriately pooled data produced. All data are made publicly available. DOI: 10.7326/M20-5261

An open letter to authors of the Russian COVID-19 vaccine trial for Sputnik V—the first such vaccine approved for widespread use—has posted on a blog run by the molecular biologist who heads science-integrity company called Resis (Samone, Italy), as reported in Nature. The letter, thus far signed by more than three dozen scientists, flags results from the vaccine trial that appear to be duplicated and calls for access to the underlying data. Trial results, which appeared recently in The Lancet, were presented only as box plots without providing a detailed breakdown of the data on which they are based. The trials tested two slightly different viral-vector vaccines on 76 volunteers. Russian authorities approved the vaccine in August and late-phase clinical trials of the vaccine, which will involve tens of thousands of people, began shortly thereafter. DOI: 10.1038/d41586-020-02619-4 

A considerable proportion (57%) of 289 lung cancer patients at a thoracic oncology clinic at the McGill University Health Center (Canada) experienced changes in their treatment plan as a direct result of the pandemic, demonstrates a study that published in JAMA Oncology. Most of the changes affected patients who were receiving palliative-intent therapy and occurred between April 26 and May 19, 2020. Of note is that active cancer treatment is not thought to be associated with increased complications from COVID-19. DOI: 10.1001/jamaoncol.2020.4408

Well-intentioned "citizen scientists" (including professional scientists) are developing homemade COVID-19 vaccines, a practice fraught with important legal, ethical and public health issues, according to experts at the University of Illinois at Urbana-Champaign, Baylor College of Medicine, Geisinger Commonwealth School of Medicine and The Ohio State University in a paper appearing in Science. Groups outside the auspices of the pharmaceutical industry have been working to develop and self-test unproven medical interventions to combat the virus, partly in the mistaken belief that self-experimentation can't be regulated by the U.S. Food and Drug Administration (FDA) and other public health authorities. The do-it-yourself approach isn’t necessarily going to help and may well prove fatal, they say. Some self-experimentation qualifies as human subjects research required to undergo ethics review. Similarly, developing a possible therapeutic product using typical equipment, chemicals and reagents would also likely be regulable by the FDA. Characterizing or positioning research as self-experimentation doesn’t eliminate risks to bystanders or the collective good. DOI: 10.1126/science.abe1963

The commonly prescribed antibiotic and potential COVID-19 drug azithromycin by itself is not associated with an increase in cardiac events, finds researchers at the University of Illinois at Chicago and the University of Pittsburgh. But when combined with certain other drugs that affect electrical impulses of the heart, azithromycin is linked with a 40% increase in cardiac events—including fainting, heart palpitations and even cardiac arrest. Their findings appear in JAMA Network Open. Doctors prescribing azithromycin should be sure that patients are not also taking a QT-prolonging drug, a list that includes blood pressure medications such as ACE inhibitors and beta-blockers, some antidepressants, anti-malaria drugs (e.g., hydroxychloroquine and chloroquine) opioid medications and even muscle relaxers. A previous study found that one in five people prescribed azithromycin also were taking a QT-prolonging drug. The risk of cardiac events with azithromycin was evaluated against the antibiotic amoxicillin and involved analyzing data from more than four million patients enrolled in private health insurance plans who were hospitalized or visited an emergency department for a cardiac event between 2009 and 2015 who took one of the two drugs. There were two million episodes in each group. DOI: 10.1001/jamanetworkopen.2020.16864

Higher viral loads are associated with a greater risk of death among cancer and non-cancer patients hospitalized with COVID-19, report researchers in Cancer Cell. Among hospitalized COVID-19 patients, those with hematologic malignancies who had recently been treated for cancer had the highest levels of SARS-CoV-2. Giving this quantitative information to providers of patients with cancer who have COVID-19 could help them decide which ones should receive more intensive in-hospital monitoring and which should receive new antiviral medicines if these treatments are in short supply. The research team previously found that high SARS-CoV-2 viral load upon presentation to the emergency department is associated with in-hospital mortality among the general inpatient population. In the new study, two standard diagnostic tests measured the amount of SARS-CoV-2 in nasopharyngeal swab specimens obtained upon admission to three New York City hospitals between March 15 and May 14, 2020; 100 of the 2,914 patients had active cancer. The overall in-hospital mortality rate was 38.8% among patients with a high viral load vs. 45.2% for cancer patients, and in both cases decreased in association with lower viral loads. DOI: 10.1016/j.ccell.2020.09.007

People who have been diagnosed with obstructive sleep apnea could be at increased risk of adverse outcomes from COVID-19, according to a study from the University of Warwick (U.K.) that published in Sleep Medicine Reviews. The conclusion was drawn from a systematic review of 18 studies published through June 2020 and highlights the need to further investigate the impact of the virus on those with the sleep condition and to better identify those currently undiagnosed with it. Eight of the referenced studies were mainly related to the risk of death from COVID-19 and 10 were related to diagnosis, treatment and management of sleep apnea. Although few studies of obstructive sleep apnea in COVID-19 had been performed at the time, there is evidence to suggest that many patients who presented to intensive care had obstructive sleep apnea and in diabetic patients it may confer an increased risk that is independent of other risk factors. In one large study in patients that had diabetes and were hospitalized for COVID-19, those being treated for obstructive sleep apnea were at 2.8 times greater risk of dying on the seventh day after hospital admission. Researchers believe that up to 85% of obstructive sleep apnea disorders in the U.K. are going undetected. DOI: 10.1016/j.smrv.2020.101382

A single-center study conducted in China suggests that daily wearers of eyeglasses may be less likely to be infected with COVID-19. Among 276 patients hospitalized with COVID-19, the proportion who had myopia and wore eyeglasses every day for more than eight hours (5.8%) was lower than that of the local population (31.5%). The hypothesis of researchers is that eyeglasses prevent or discourage wearers from touching their eyes, thus avoiding transferring the virus from the hands to the eyes. Eyes usually lack protection, and an abundance of the SARS-CoV-2 receptor ACE-2 has been found on the ocular surface, through which the virus can enter the human body. DOI: 10.1001/jamaophthalmol.2020.3906


Industry Updates

Reducing or eliminating high blood pressure medications if blood pressure becomes hypotensive could prevent acute kidney injury (AKI) and death in COVID-19 patients, according to research presented at the recent American Heart Association's (AHA’s) Hypertension 2020 Scientific Sessions. Early in the COVID-19 pandemic, the AHA issued a joint statement with the Heart Failure Society of America and the American College of Cardiology recommending the continued use of ACE-i and ARB medications among patients already taking them for indications such as heart failure, hypertension or ischemic heart disease. The latest finding stems from a study involving 392 COVID-19 patients hospitalized at a single center in Italy between March 2 and April 25, 2020. Patients presenting to the emergency department who had severe hypotension (lower than 95/50 mm Hg) were nine times more likely to have AKI while those who had mild hypotension (below 120/70 mm Hg but not in the severe range) were four times more likely to have AKI. Overall, in-hospital death was twice as likely in patients with mild hypotension, regardless of age, other diseases and COVID-19 severity. Press release.

Vaxart, Inc. has announced that the FDA has completed its review of the company’s Investigational New Drug application for a phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate and provided an update on its COVID-19 program. The room-temperature stable tablet is significantly easier and cheaper to store and distribute, as it does not require refrigerated cold chain required for injectable vaccines. The FDA-cleared open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old and its primary objective is to examine the safety and reactogenicity of two doses of the vaccine. In early August, the company also began a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen for its vaccine candidate; results are expected mid-October. Press release

COVID-19 has generated a huge backlog in oncology care and research—and the threat of delayed diagnoses looms while oncology professionals face burnout, according to new studies discussed at the ESMO (European Society for Medical Oncology) Virtual Congress 2020. Weaknesses in how cancer care is resourced and organized may be partly to blame. In one global study, 60.9% of oncology centers reported that clinical activity was reduced at the peak of the pandemic, while 64.2% cited under-treatment as a major concern and 37% expected to see significant reductions in clinical trials this year. In another large study, the vast majority (88%) of responding cancer centers say they faced challenges in providing care during the pandemic, with 54% and 45% reporting cases of coronavirus among their patients and staff, respectively. While half reduced services pre-emptively, others were forced to do so after being overwhelmed by the situation or following a shortage of personal protective equipment, staff and medicines. Two large surveys also suggest well-being and burnout rates among oncology professionals have worsened. Press release

The 2020 National Poll on Healthy Aging suggests that staying close to home and avoiding crowded places to reduce the risk of contracting COVID-19 comes with a cost for older adults, especially for those with health challenges. In the poll, conducted in June for the University of Michigan's Institute for Healthcare Policy and Innovation, 56% of people over the age of 50 said they sometimes or often felt isolated from others—more than double the proportion who felt that way in a similar poll in 2018. Nearly half also said they felt more isolated than they had just before the pandemic arrived in the U.S., and a third said they felt they had less companionship than before. Social contacts suffered too, with 46% of older adults reporting that they infrequently interacted with friends, neighbors or family outside their household versus 28% in the 2018 poll. Among the bright spots were that the 46% of older adults reporting interactions with people in their neighborhood at least once a week were less likely to say they'd experienced forms of loneliness. Technology also helped many people over 50 connect with others. Older adults frequently engage in healthy behaviors despite the pandemic, including 80% eating a healthy diet and 81% getting enough sleep, mirroring findings from the 2018 poll. Press release.

COVID-19 and interlinkages to endocrine and metabolic diseases was an important program topic at the 2020 European Congress of Endocrinology (ECE). From the beginning of the pandemic, it has been clear that patients with underlying endocrine diseases (e.g., diabetes, obesity, autoimmune thyroid disease) were more at risk of developing severe COVID-19. It was announced during the weeklong meeting that the EU is investing heavily together with member states in trying to effectively prevent non-communicable diseases, and presenters shared that vitamin D deficiency makes people more vulnerable to infection and may increase lung damage. Recent studies have additionally shown that certain underlying conditions, associated with exposure to endocrine-disrupting chemicals, are exacerbating the effects of COVID-19 in vulnerable populations. Endocrine systems could suffer in the long term from the impact of COVID-19, since the hormone system is the key regulator of body weight, energy expenditure and food intake. COVID-19 has in fact been associated with anorexia, dysgeusia, dysfunction of gastrointestinal absorption and severe weight loss, mostly from muscle mass. Press release.

Artificial intelligence (AI) might be able to predict outcomes in COVID-19 patients, according to researchers at the West Virginia University School of Medicine who are using AI to study how coal miners are being affected by the novel coronavirus. They’re also investigating the impact of smoking, vaping and having a chronic lung condition. The team will next work with a machine learning model—produced by project partner SporeDatato predict patient outcomes based on demographic and health data associated with COVID-19 patients in West Virginia. The model will consider whether patients have asthma, chronic obstructive pulmonary disease or other lung conditions; appraise CT scans of their lungs; and consider whether they have chronic lung disease, smoke or vape, or have worked in a coal mine. The West Virginia Clinical and Translational Science Institute is funding the $30,000 project. The model could help doctors individualize care for COVID-19 patients, rather than taking a one-size-fits-all approach. Press release.

Researchers at The Saban Research Institute of Children's Hospital Los Angeles, as well as in Nicaragua and New Zealand, are enrolling 250-325 households in a new study designed to answer questions about how COVID-9 spreads within households—including why some family members develop the viral infection and others do not, how long someone remains infectious, if there are “super-spreaders” and, if so, whether they include children. The study is being funded by a $7.1 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) and is an extension of a seven-year NIAID-funded study into influenza focusing on how a child's first exposure to the flu virus might produce a long-lasting immunological response. The influenza study, launched in fall 2019, will recruit about 3,100 children in Los Angeles, New Zealand, and Nicaragua and 12 institutions from across North America, Australia, and New Zealand. Children's Hospital Los Angeles researchers received $1.2 million of the grant for the U.S. portion of the study and plan to enroll up to 100 households and follow them over two years. Press release

The National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools like smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals. The projects represent a broad range of solutions for immediate public health needs related to the pandemic, and several focus on solutions for medically underserved communities and people with limited access to healthcare who are disproportionally affected by COVID-19. Award recipients include Evidation Health, Inc. (San Mateo, California), IBM (Armonk, New York), iCrypto, Inc. (Santa Clara, California), physIQ, Inc. (Chicago, Illinois), Shee Atiká Enterprises, LLC (Sitka, Alaska), University of California, San Francisco, and Vibrent Health (Fairfax, Virginia). Separately, a contract was also awarded to CareEvolution, LLC (Ann Arbor, Michigan) for a digital health solution that integrates self-reported symptoms, data from consumer wearable devices, electronic health record and claims data, and COVID-19 test results to indicate whether users are ready to return to work and normal activities during the COVID-19 pandemic. Press release.

A study on the effectiveness of multiple treatments, including laboratory-made antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting is underway by researchers at The University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System's Lyndon B. Johnson Hospital. UTHealth is launching the Houston site of the nationwide ACTIV-2 trial, a public-private partnership led by the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (aka ACTIV) program. The first treatment being tested is LY-CoV555, an investigational monoclonal antibody developed from the blood sample of a recovered COVID-19 patient. Between five and 10 patients will be enrolled into the phase 2 study, which is expected to last roughly six months. Press release.

Researchers at the Biomedical Research Institute of Malaga (Spain) have received funding from American pharmaceutical company Ferring to look at the risks that COVID-19 infection may pose to pregnant women, particularly to their placenta and fetus. The plan is to analyze placentas from women who give birth anywhere in the Andalusia region of Spain and test positive for COVID-19 or tested positive during pregnancy. The project will create the first placental tissue and cord blood bank of COVID-19 cases and gestation in a public biobank, and all related clinical and epidemiological data will be accessible to facilitate the correlation between results from the analysis performed and the medical, obstetrical, and neonatological variables gathered. More than 24 hospitals will collaborate on the three-year project. First results will be obtained in the second quarter of 2021. Press release.

A University of Illinois Chicago research study on how to improve care for heart disease patients struggling with hopelessness has been supplemented by the NIH to determine whether the study intervention called "Heart Up!" limits the negative impact of COVID-19 shelter-in-place and physical distancing measures on health outcomes. The grant’s supplement will allow researchers to compare the impact of the intervention on 43 patients enrolled in a Heart Up! Study prior to the COVID-19 pandemic with patients enrolled thereafter and extends the follow-up for all patients to one year. The study is aimed at motivating patients to be more physically active. The funds also will support adding two COVID-19-related questionnaires for patients: Multi-Ethnic Study of Atherosclerosis COVID-19 Questionnaire to assess COVID-19 symptoms, diagnosis, testing and social distancing; and Coronavirus Impact Scale to quantify how COVID-19 has changed the participant's life via routine; income/employment; access to food, medical care, mental health care and extended family; and stress/discord. Press release.

The National Institutes of Health (NIH) has awarded $12 million to the nonprofit research institute RTI International for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The grant will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center. CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians—populations that account for over half of all reported cases in the United States. They also will promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic clinical trials to prevent and treat the disease. The teams include NIH and other federally funded entities that have community engagement expertise, non-academic community-based organizations, and Federally Qualified Health Centers, as well as state and/or local health departments. Press release.

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