Research News

Many recovered COVID-19 patients have lasting respiratory and psychophysical effects months after hospital discharge, finds a new study published in JAMA Network Open. Researchers studied a patient cohort of 238 individuals hospitalized for severe COVID-19 in Northern Italy to evaluate the prevalence of lung anomalies, exercise function impairment, and psychological sequelae at four months post-discharge. They found that more than half of the participants had a significant reduction of diffusing lung capacity for carbon monoxide or measurable functional impairment, and approximately one-fifth of the patients in the study had symptoms of post-traumatic stress four months after their discharge. DOI:10.1001/jamanetworkopen.2020.36142

COVID-19 mortality rates are significantly higher in pregnant mothers than in similarly aged individuals, according to a study published in American Journal of Obstetrics and Gynecology. The study followed 240 pregnant women between March and June 2020 and found that the pregnant women with COVID-19 had a 3.5 times higher COVID-19 associated hospitalization rate than the similarly aged general population in Washington State. The researchers also found that COVID-19 mortality rates were 13 times higher in pregnant mothers than in similarly aged individuals. They did add, however, that most of the pregnant patients with COVID-19 had asymptomatic or mild COVID-19 disease and healthy pregnancies. DOI:10.1016/j.ajog.2020.12.1221

Early anticoagulation therapy in critically ill COVID-19 patients did not affect survival in an observational study published in Annals of Internal Medicine. Researchers studied health records for over 3,200 adult patients with severe COVID-19 from 67 centers throughout the United States to evaluate the incidence of venous thromboembolism (VTE) and major bleeding and examine the observational effect of early therapeutic anticoagulation on survival. They found that patients who received therapeutic anticoagulation in the first 2 days of intensive care admission had a similar in-hospital survival rate compared to those who did not. They also determined that rates of VTE in critically ill COVID-19 patients may be considerably lower than previously reported in smaller studies. DOI:10.7326/M20-6739

Reports of adverse drug reactions (ADRs) for hydroxychloroquine and chloroquine more than doubled during the first months of the COVID-19 pandemic, when use of those medications was substantially higher, compared to the same months in 2018 and 2019, reports a new study published in Annals of Internal Medicine. Researchers in France used the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to quantify the change in number and type of reported ADRs associated with the two drugs. Their data showed this significant increase in the number of reported ADRs for chloroquine and hydroxychloroquine in 2020 when compared to the same time period in 2018 and 2019. Of the ADRs reported in 2020, 97.1% were considered serious, compared to 73.4% and 84.8% being defined as serious in 2018 and 2019, respectively. The authors also note that countries in 2020 with the highest reported ADRs were also those most affected by the virus, and despite the FDA’s revocation of its emergency use authorization (EUA), the number of reported ADRs remained high. DOI:10.7326/M20-7918

Researchers with the Fatty Acid Research Institute (FARI) and collaborators at Cedars-Sinai Medical Center have published evidence that higher omega-3 blood levels may reduce risk of death from COVID-19 infection. The study included 100 patients admitted to the hospital with COVID-19 for whom admission blood samples had been stored, and clinical outcomes for these patients were obtained and blood was analyzed for the Omega-3 Index (O3I). After adjusting for age and sex, those with the highest O3I were 75% less likely to die compared to those with a lower O3I. The researchers note that these are preliminary findings and larger studies are needed to confirm these effects of omega-3 fatty acids (DHA and EPA). This study is published in Prostaglandins, Leukotrienes, and Essential Fatty Acids. DOI:10.1016/j.plefa.2021.102250

Increased cumulative exposure to cigarette smoke, measured in pack years, is associated with a higher risk of hospitalization and mortality from COVID-19, according to a new study published in JAMA Internal Medicine. Researchers used a patient cohort of approximately 7,100 individuals, all who were part of the Cleveland Clinic COVID-19 registry. Of those patients, 84.8% were never smokers, 2.4% were current smokers, and 12.8% were former smokers. They found that patients who smoked more than 30 pack-years had a 2.25 times higher odds of hospitalization and were 1.89 times more likely to die following a COVID-19 diagnosis when compared to the patients who have never smoked. The researchers add that similar odds ratios were seen in both current and former smokers, concluding that cumulative smoking, rather than current smoking status, is an independent risk factor for adverse outcomes with COVID-19 infection. DOI:10.1001/jamainternmed.2020.8360

Negative mental health effects of lockdowns are temporary and fade over time, finds University of Illinois Urbana-Champaign researchers. Their study, published in Economics and Human Biology, measured mental health trends from January 2020 through the end of June by analyzing daily, state-located search data via Google trends. The researchers first used a set of terms related to mitigation policies, and then obtained data on searches about mental health. They found that the effects on searches for isolation and worry due to the mitigation policies spiked temporarily and decreased gradually over time. Searches for exercise, Netflix and cooking were positively associated with the stay-at-home policy. The policies correlated with a reduction in searches for antidepressants and suicide, revealing no evidence of increases in severe mental health symptoms, according to the researchers. DOI:10.1016/j.ehb.2020.100963

U.S. counties with higher income inequality faced higher rates of COVID-19 infections and deaths in the first 200 days of the pandemic, and counties with higher proportions of Black and Hispanic residents also experienced higher rates. This is according to a new study published in JAMA Network Open. These findings were based on county-level data for all 50 states and Washington, D.C., which included the Centers for Disease Control and Prevention (CDC), USAFacts, and the U.S. Census Bureau. The researchers determined that a 1.0% increase in a county’s Black population corresponded to an average 1.9% increase in infections and 2.6% increased in mortality from COVID-19, with similar increases seen when looking at the Hispanic population. They also found a 1.0% rise in a county’s income inequality corresponded to an average 2.0% rise in COVID-19 incidence and a 3.0% rise in mortality from the virus. DOI:10.1001/jamanetworkopen.2020.34578

Monash University researchers have discovered two new molecules that provide profound protection in experimental models of asthma, as well as protection from acute respiratory distress syndrome (ARDS) that is seen in some patients with severe COVID-19. In their study, originally designed to investigate how the immune system impacts gut bacteria, the researchers found that p-cresol sulfate (PCS), a gut bacteria by-product, led to a striking protection against asthma. They then determined that PCS was produced by enhanced bacterial metabolism of L-tyrosine, a well-known amino acid found in dietary supplements. The researchers saw significant protection against lung inflammation in mice given either L-tyrosine or PCS, as well as protection from ARDS. The researchers now aim to test one of the molecules in a clinical trial in asthmatics this year. These new findings are published in Nature Immunology. DOI:10.1038/s41590-020-00856-3

Combined treatment with extracorporeal membrane oxygenation (ECMO) and continuous renal replacement therapy (CRRT) could be an important treatment technique for patients critically ill with SARS-CoV-2 pneumonia. Chinese researchers collected data on three patients with severe COVID-19 and pneumonia at Tongji Hospital in whom conventional treatments had failed. All three patients were male with a mean age of 50.6 years. The researchers of the study, published in Cardiovascular Innovations and Applications, report that survival rate of the patients with cardiopulmonary failure treated with ECMO/CRRT in this group was 100%, which they believe indicates that this combined treatment is an important treatment technique for patients critically ill with SARS-CoV-2 pneumonia. DOI:10.15212/CVIA.2019.1267

Asian and Black patients suffered disproportionate rates of premature death from COVID-19, according to a study of over 1,700 patients by Queen Mary University of London and Barts Health NHS Trust. The study, published in BMJ Open, represents one of the largest and most diverse UK hospital COVID-19 patient cohorts, with only 35.2%  of patients identified as White ethnicity. Researchers found that Asian patients were 1.54 times more likely, and Black patients 1.8 times more likely, to be admitted to the intensive care unit and receive mechanical ventilation when compared to White patients. Of the 1,737 individuals in the diverse patient cohort, 511 had died by day 30 (29%). DOI:10.1136/bmjopen-2020-042140

A new study, published in JAMA Network, reports the incidence of reported anaphylaxis, after administration of the first dose of Pfizer-BioNTech COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) identified 21 case reports submitted to the Vaccine Adverse Event Reporting System (VAERS) that met Brighton Collaboration case definition criteria for anaphylaxis. With a reported 1,893,360 fist doses of the vaccine given, this number corresponds to an estimated rate of 11.1 cases of anaphylaxis per million doses administered. Four of these patients were hospitalized (19%), 17 were treated in an emergency department (81%), and 20 are known to have been discharged home or had recovered at the time of the report to VAERS (95%). The study notes that 81%  of those 21 patients with anaphylaxis had a documented history of allergies or allergic reactions, including to drugs or medical products, foods, and insect stings. The authors conclude that clinicians have an important role in vaccine safety monitoring by being vigilant and recognizing and reporting adverse events to VAERS. DOI:10.1001/jama.2021.0600

1 in 3 people infected with SARS-CoV-2 are asymptomatic, a new study published in the Annals of Internal Medicine has found. Researchers reviewed 61 studies and reports including over 1.8 million individuals to determine this finding, which builds upon a previous review of a more limited data set that also determined that a significant portion of infections were asymptomatic. The authors suggest that widespread at-home testing to include even those without symptoms could help to identify infected individuals before transmitting the virus unknowingly, as about half of new infections are believed to be caused by people who are pre-symptomatic or asymptomatic. DOI:10.7326/M20-6976

A global study, led by Flinders University, of over 1,000 online participants finds that more than 13%  of the sample had post-traumatic stress disorder (PTSD) symptoms related to the stresses of the ongoing COVID-19 pandemic. The online survey examined a range of responses to common post-traumatic stress symptoms, such as repeated disturbing images or memories about the pandemic. They found that reported traumatic stress was related to future events, such as worry about oneself or a family member contracting the virus, as well as indirect contact such as the media or government lockdown. The researchers note that only 2%  of the total sample reported testing positive for COVID-19 and only 5%  reported that close family and friends had tested positive. This study is published in PLOS ONE. DOI:10.1371/journal.pone.0240146

Vaccinating older adults for COVID-19 first and speeding up roll-out of the vaccines will save a substantial number of U.S lives, finds University of Colorado Boulder researchers. Using mathematical modeling, the team used five different scenarios in which a different age group got vaccinated first. They also drew on demographic information from different countries. Their modeling projected that in most scenarios, across countries, prioritizing adults over 60 years old saved the most lives. They also found that if roll-out speed was doubled from current rates under current transmission conditions, COVID-19 mortality could be reduced by about 23% , or 65,000 lives, over the next three months. These projections are published in Science. DOI:10.1126/science.abe6959

Cluster randomized trials (CRT) could help return children safely to schools, according to an international research team led by scientists at the University of Birmingham. The team of experts explain that school reopening policies currently lack a rigorous evidence base, which has led to a wide variation in policies around the world. They believe that CRTs are a rigorous and ethical way to resolve these uncertainties, with a few important requirements for trial design. The researchers suggest such trials be conducted only when community transmission is under control and health system has capacity. They also suggest that the study includes many regions of the community and that entire regions would be randomized to either remain closed or to re-open. For schools reopening, precautions such as mask-wearing and social distancing should continue. These recommendations are published in Clinical Trials. DOI:10.1177/1740774520984860

A new research agenda developed by the Society for Healthcare Epidemiology of America (SHEA) has been published in Infection Control & Hospital Epidemiology that defines the critical areas of study to inform clinical practice, policy, and prevention strategies for COVID-19 and future pandemics. Some of the most critical areas for research include understanding the spread of the virus through asymptomatic carriers and the long-term health impacts of COVID-19, according to the authors. They also suggest the need to develop tools to identify outbreaks more rapidly in hospitals, nursing homes, and other healthcare settings leading to early interventions and to improve the understanding of personal protective equipment (PPE), as well as continued need for PPE during and after the pandemic. The authors note that this research agenda represents expert opinions at a moment in time during the COVID-19 pandemic and priorities may shift as it evolves. DOI:10.1017/ice.2021.25

Vanderbilt University Medical Center (VUMC) researchers, along with their colleagues, have identified genetic factors that increase the risk for developing pneumonia to help identify patients with COVID-19 at greatest risk for this life-threatening complication. The researchers conducted genome-wide association studies (GWAS) of more than 85,000 patients whose genetic information is stored in VUMC’s BioVU biobank. They identified nearly 9,000 cases of pneumonia in patients of European ancestry and 1,710 cases in patients of African ancestry. After further analysis, the research team linked the gene that causes cystic fibrosis (CF) and European ancestry and the mutation that causes sickle cell disease (SCD) in patients of African ancestry as the strongest pneumonia associations. After removing patients with CF and SCD, they then pinpointed a pneumonia-associated variation in a gene called R3HCC1L in patients of European ancestry, and one near a gene called UQCRFS1 in patients of African ancestry. They believe these findings could be applied to identifying patients with high risk of severe pneumonia to enable early interventions. They have published this work in the American Journal of Human Genetics. DOI:10.1016/j.ajhg.2020.12.010

COVID-19 is dangerous for middle-aged adults, not just the elderly, finds a systematic review of all available studies of COVID-19 prevalence in countries with advanced economies. The review encompassed more than 1,000 research papers and government documents disseminated prior to September 18, 2020. The research team, led at Dartmouth College, determined the odds that an infection becomes fatal is only 1:10,000 at age 25 and those odds increase to roughly 1:100 at age 60, 1:40 at age 70, and 1:10 at age 80. The researchers report that nearly 40%  of U.S. COVID-19 deaths have occurred among those ages 45 to 74 years old and almost 60%  have occurred among those over 75 years old. The team emphasizes the urgent implications of these findings, such as maintaining basic precautions (wearing a mask, practicing social distancing, and frequent hand washing) while vaccines are being distributed over the next several months. This research is published in the European Journal of Epidemiology. DOI:10.1007/s10654-020-00698-1

People with Barrett’s esophagus, a common problem of the upper gastrointestinal (GI) tract, may be more vulnerable to COVID-19 through swallowing the virus. Washington University School of Medicine researchers analyzed tissues from 30 patients with the GI disorder and found that cells in the tissue samples all had receptors for the SARS-CoV-2 virus, which normal esophagus cells lack. They then built and cultured organoids from those Barrett’s esophagus tissue samples and other tissue samples without the GI disorder. The researchers found that the virus was able to bind to and infect the mini organs built from tissue from people with Barrett’s esophagus. Most concerning, the more cells in a specific patient’s mini esophagus culture resembled intestine, the more the virus bound to and infected that culture. The researchers express worry that Barrett’s patients may be more susceptible to infection with COVID-19 from foods containing viral particles and further investigation is needed. This study is published in Gastroenterology. DOI:10.1053/j.gastro.2021.01.024

Recovered COVID-19 patients could be protected against the virus for at least six months, according to Rockefeller University researchers. The research team also discovered that antibodies produced months after infection showed increased ability to block SARS-CoV-2, as well as its mutated versions such as the South African variant. These improved antibodies are produced by immune cells that have kept evolving, potentially due to a continued exposure to the remnants of the virus hidden in the gut tissue. The team studied the antibody responses of 87 individuals one month after infection and again at six months post-infection and found the patients’ memory B cells, specifically those that produce antibodies against SARS-CoV-2, did not decline and slightly increased in some cases. They determined that these memory B cells had gone through several rounds of mutation even after the infection resolved, resulting in the production of much more effective antibodies. Upon further investigation, the researchers found the presence of SARS-CoV-2 genetic material and its proteins in the cells that line the intestines. These finding are published in Nature. DOI:10.1038/s41586-021-03207-w

Bamlanivimab (LY-CoV555) had no significant effect on viral load when used alone in patients with mild to moderate COVID-19, a new study finds that is published in JAMA. The BLAZE-1 study, which was a randomized phase 2/3 trial at 49 U.S. centers, included 577 patients who tested positive for SARS-CoV-2 and had 1 or more mild to moderate symptom. Researchers found that there was no significant difference in change in viral load with 3 different doses of bamlanivimab monotherapy compared with placebo. They did find, however, that treatment with a combination of bamlanivimab and etesevimab significantly decreased SARS-CoV-2 viral load by day 11 compared with placebo. DOI:10.1001/jama.2021.0202

A new study published in Cardiovascular Innovations and Applications finds that high levels of inflammatory biomarkers are associated with a higher risk of cardiac injury in patients with severe COVID-19. For this study, data was collected on 91 patients with a confirmed diagnosis of severe COVID-19 and the relationship between cardiac injury and inflammatory biomarkers was analyzed. Researchers determined that the levels of inflammatory biomarkers in patients who experienced cardiac injury was generally higher than the levels of those without cardiac injury. They also found interleukin-2 receptor (IL-2R) and comorbidities, such as hypertension and coronary heart disease, to be independent risk factors for cardiac injury in severe COVID-19 patients. DOI:10.15212/CVIA.2019.1264

Industry News

The Feinstein Institutes for Medical Research and Cold Spring Harbor Laboratory (CSHL) are recruiting patients in a fully virtual and in-home clinical trial to evaluate the safety and efficacy of famotidine (Pepcid) for the outpatient treatment of COVID-19 in adults. In April 2020, the Feinstein Institutes began the nation’s first Pepcid clinical trial, which enrolled more than 230 patients, based on anecdotal reports from China that patients taking the drug had better outcomes from COVID-19. They hope that this innovative clinical trial of patients in their homes will provide important data to determine if this safe and inexpensive drug could be useful for COVID-19 patients. For those who qualify, once consented, patients will be trained to use a cellular Apple iPad, along with other simple measurement devices, and be prescribed famotidine at 240 mg per day or placebo for up to two weeks. Northwell’s Home Lab program will be utilized for blood draw and COVID-19 diagnostic nasal swab tests. Press Release

23andMe has created a COVID-19 Severity Calculator to help people gauge their risk of being hospitalized with the novel coronavirus, based on several factors from the 23andMe COVID-19 Research Study. The interactive tool allows users to plug in different biometrics, lifestyle factors, and pre-existing conditions to better understand their likelihood of hospitalization based on risk factors identified in the study. The 23andMe COVID-19 Research Study collected data from more than a million participants, of whom nearly 10,000 were diagnosed with COVID-19 and nearly 750 were hospitalized with severe symptoms. The COVID-19 Severity Calculator can highlight how a few underlying health conditions might factor into hospitalizations due to the virus, however, it does not take into account all factors that might increase likelihood of hospitalization. This tool is free and now available to the general public, not just 23andMe customers. Press Release

Stirling Ultracold announced that it will be the exclusive ultra-low temperature (ULT) freezer provider for the entire island of Puerto Rico, as well as all U.S. embassy locations around the world. The Puerto Rico National Guard has partnered with Select Gases of Atlanta and Bionuclear of Puerto Rico to purchase and distribute four of Stirling Ultracold’s upright, undercounter, and portable freezers to vaccinate the island. The State Department has purchased and already received a shipment of Stirling’s portable freezers to thermally protect and move vaccines to all U.S. embassy locations in order to safely vaccinated government employees and officials around the world. Press Release

Vaccine Pods launched an industry-first technology that revolutionizes the way that sensitive vaccines are transported, stored, and distributed. Developed in partnership with HCI Energy, the new technology allows the ability to streamline Cold Chain logistics by directly shipping a container with COVID-19 vaccines safely stored in an Ultra-Low Temperature (ULT) freezer that is powered by the containers’ integrated power source. Vaccine Pods created a power solution that leverages sustainable energy to minimize reliance on the electrical grid or fossil fuels, which enables uninterrupted cold chain management and delivery of vaccines anywhere in the world. This technology has been designed for use with Stirling Ultracold’s vaccine freezers. Press Release

86%  of doctors believe that mental health issues and depression will be the biggest non-COVID-19 public health issue after the pandemic. This is according to survey conducted by Sermo, as part of its COVID-19 Real Time Barometer, that fielded insights from over 3,000 physicians across the globe from January 8 - January 13, 2021. The study also revealed that the majority of doctors (53%) believe the long-term side effects of COVID-19 will be the biggest COVID-related public health issue over the next year. Additionally, almost two out of three physicians do not believe or are unsure whether the United States and the world will return to normal after the vaccine is rolled out. 64% of the doctors surveyed stated that they are concerned that a new COVID virus is on the horizon, while 53% of participants believe the next pandemic will arrive in 5 or more years. Press Release

The National Institutes of Health (NIH) has launched a new database to track COVID-19-related neurological symptoms, complications, and outcomes, as well as COVID-19 effects on pre-existing neurological conditions. The COVID-19 Neuro Databank/Biobank (NeuroCOVID), which was created and will be maintained by NYU Langone Health, will be a resource of clinical information as well as biospecimens from patients of all ages who have experienced neurological complications associated with COVID-19. The new database is supported by NIH’s National Institute of Neurological Disorders and Stroke (NINDS) in hopes to address the urgent need to understand COVID-19-related neurological conditions that can cause devastating and lasting effects. Press Release

Barts Charity is funding a new study led at Queen Mary University of London that will focus on East London, a multi-ethnic area that has some of the United Kingdom’s highest incidence and death rates of COVID-19. The study aims to gain deep insight into the causes of COVID-19 based on the lived experience of East London’s racially diverse communities through interviews and questionnaires. The researchers will work directly with local residents to understand their lives before and during the pandemic. They believe this research will help NHS and policymakers develop strategies to reduce the devasting impact of COVID-19 on Black, Asian, and minority ethnic communities and could also provide useful insights for many other health issues where ethnic disparities exist. Press Release

Turn Therapeutics announced the initiation of a two-part, four-arm, human safety and efficacy trial for its intranasal and antiviral COVID-19 therapeutic candidate, Hexagon. The randomized, placebo-controlled trial will enroll approximately 100 mild-to-moderate COVID-19 patients and 50 healthcare workers in Panama. The treatment arms will assess the efficacy of a nasal decolonization protocol over five days in reducing viral load and symptoms. The prevention arm will assess Hexagon’s ability to prevent COVID-19 infection in frontline workers when worn intranasally as an adjunct to personal protective equipment (PPE). Press Release

Cerba Research has developed two new time-saving COVID-19 exploratory tools to enhance clinical research for the development of vaccines and treatments for the novel coronavirus and other infectious diseases. These new tools can help clinical researchers develop more tailored and effective treatments. They are available and efficient on clinical specimens, and the whole-genome sequencing in next-generation sequencing (NGS) assay is available for other viruses responsible for respiratory diseases, such as influenza. Press Release

Intalere now offers a Senior Living COVID-19 Toolkit that features solutions, contracts and educational and care assets to help senior living and long-term care members respond to the ongoing effects of the COVID-19 pandemic. The toolkit is built around several resource areas including: COVID-19 diagnostic testing resources, resident care resources that address social wellness and infection prevention, and coping resources for caregivers. Press Release

The National Comprehensive Cancer Network (NCCN) has shared new information to provide guidance for COVID-19 vaccinations in people with cancer. The NCCN COVID-19 Vaccine Committee, which includes top hematology and oncology experts, recommends that all people currently in active cancer treatment should get the vaccine, with some advice to consider regarding immunosuppression and timing. This new guidance statement from NCCN builds off of existing understanding and guidelines for the flu vaccine during active cancer treatment, such as those in the NCCN Clinical Practice Guidelines in Oncology for Prevention and Treatment of Cancer-Related Infections. The guidance acknowledges that although these vaccines have been shown to be safe in general populations, their effectiveness among cancer and transplant patients is not precisely known at present. The committee feels strongly that caregivers and other members of the same household should also be encouraged to get the vaccine as soon as they are considered eligible. Press Release