Mass COVID testing at UK universities is haphazard and unscientific, finds BMJ investigation

covid test

The costly rollout of asymptomatic screening for COVID-19 at UK universities has found very few positive cases following its launch in December as part of the Government’s ambitious £100bn Moonshot programme, finds an investigation published by The BMJ today.

It reveals that almost two thirds of higher education institutions are not collecting data on the number of students being tested and a third are not logging how many test positive. Experts have described campus testing as haphazard and messy with a price tag that is “outrageous.”

On 17 Feb 2021 The BMJ sent Freedom of Information requests to the 216 universities and colleges eligible to receive public funding for twice weekly lateral flow testing for students, asking how much they received, how many tests they had carried out, and how many positive tests came back.

Among 69 institutions that disclosed three months worth of data, 1,649 positive results were reported from 335,383 tests carried out, a 0.5% positive rate.

The BMJ also found widespread reluctance among universities and colleges to share information about costs and the effects of testing on containing the virus.

Only 16 institutions disclosed complete data on their funding, the number of tests carried out, and the number of positive results. These showed that the government spent roughly £3,000 per positive test result yielded.

But experts said this is likely to be a vast underestimation of the full cost, as factors such as staffing of testing sites were not included.

Allyson Pollock, professor of public health at Newcastle University, and a vocal critic of the testing programme, said, “The clear message from the data is that the mass testing is haphazard, fragmented, disjointed and absolutely the antithesis of public health.”

And she urged universities to abandon asymptomatic testing and instead focus on testing those with symptoms, particularly as students return to campuses and prevalence of COVID is falling to low levels.

Jon Deeks, professor of biostatistics at the University of Birmingham and leader of the Cochrane Collaboration’s COVID-19 test evaluation activities, points to data from England’s Test and Trace service which suggest that the cost of asymptomatic testing in schools could be as much as £120,000 per case found, and said it was crucial that the Department of Health and Social Care published an analysis of data that it was collecting from universities in England.

Angela Raffle, consultant in Public Health and honorary senior lecturer at Bristol University, who has worked for the UK National Screening Programmes since their inception in 1996, described the rollout of asymptomatic testing as “a lost opportunity.”

She said the whole thing is “a desperate exercise in trying to get favourable publicity for number 10, trying to get rid of the Innova test mountain, and trying to change the culture in this country so that we start to think that regular tests for everybody is a worthwhile use of public resources, which it isn’t.”

The government told The BMJ that it was up to universities to determine their testing approach, but said it was committed to working with them to offer twice weekly asymptomatic testing to all students on campus.

A government spokesperson said, “Protecting communities and saving lives is always our first priority and every pound spent is contributing towards our efforts to keep people safe. Testing at universities is a key pillar in reducing transmission risks, and allowing more students to return to face-to-face study as safely as possible.”

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Cells burn more calories after just one bout of moderate aerobic exercise, study finds

Cells burn more calories after just one bout of moderate aerobic exercise, OSU study finds

In a recent study testing the effects of exercise on overall metabolism, researchers at Oregon State University found that even a single session of moderate aerobic exercise makes a difference in the cells of otherwise sedentary people.

Mitochondria are the part of the cell responsible for the biological process of respiration, which turns fuels such as sugars and fats into energy, so the researchers focused only on mitochondria function.

“What we found is that, regardless of what fuel the mitochondria were using, there were mild increases in the ability to burn off the fuels,” said Matt Robinson, lead author on the study and an assistant professor in the College of Public Health and Human Sciences.

OSU researchers recruited participants who do not follow a regular exercise routine and had them ride a stationary bike for an hour at a moderate intensity. They biopsied their muscles 15 minutes later to test how efficient the mitochondria were after the exercise was completed and compared those results with a resting day.

Post-exercise, study participants’ mitochondria burned 12-13% more fat-based fuel and 14-17% more sugar-based fuel. While the effects were not drastic, they were consistent, Robinson said.

“It’s pretty remarkable that even after just one hour of exercise, these people were able to burn off a little more fuel,” he said.

Previous research in the field has long established that regular exercise creates lasting change in people’s metabolism, making their bodies burn more energy even when they’re not working out.

Prior studies have looked at highly trained or athletic people, but Robinson’s team wanted to look specifically at singular bouts of exercise in people who were generally active and disease-free but who did not have structured exercise regimes. These people were on the lower end of fitness, which is associated with low mitochondrial abundance and energy production. Participants were monitored while working out at approximately 65% of their maximal effort, where they could keep up the cycling pace for an hour or more and still comfortably carry on a conversation.

Robinson said they’re hoping these results help break down the mental barrier of people thinking they need to be elite athletes for exercise to make an impact on their health.

“From a big picture health perspective, it’s very encouraging for people to realize that you can get health benefits from a single session of exercise,” Robinson said. “We’re trying to encourage people, ‘You did one, why don’t you try to do two? Let’s do three.’

“We know that exercise is good for you, in general. But those benefits of that single bout of exercise seem to fade away after a day or two. You get the long-term benefits when you do that exercise again and again and you make it a regular habit.”

In this study, Robinson’s research team focused narrowly on mitochondria to find out how big a role mitochondria play in the overall function of muscle metabolism. Other studies are looking at changes in blood flow to the muscle and how the muscle metabolizes fats versus sugars.

From a disease perspective, Robinson said it’s clear that obesity and diabetes involve impairments in metabolism. Physiologically, when the body undergoes exercise, sugars tend to be burned off first while fats are stored, but in cases of diabetes and obesity, there is some dysregulation in metabolism that causes the body to not be able to switch between the two types of fuel.

Exercise can help reset that system, he said.

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More burnout among pregnancy, newborn care providers during pandemic, study finds

More burnout among pregnancy, newborn care providers during pandemic, study finds

Medical professionals who care for pregnant women and newborns experienced greatly increased rates of burnout during the early days of the COVID-19 pandemic, according to a small study led by Stanford University School of Medicine researchers.

The results was published online March 16 in the Journal of Perinatology.

Among the 288 people, mostly nurses and physicians, from across the United States who responded to a June 2020 survey, 66% reported symptoms of burnout. In addition, 73% felt that their co-workers were showing more burnout. The findings raise concerns for patient safety, according to the study’s authors.

“The levels of burnout are about 2.5 times the rates we observed in pre-pandemic samples,” said Jochen Profit, MD, the study’s senior author and an associate professor of pediatrics at Stanford. The extent of caregiver burnout his team documented was equivalent to implementing new electronic medical records systems—an event widely recognized as stressful—twice in a row, Profit said. The study’s lead author is Eman Haidari, MD, medical fellow in pediatrics at Stanford.

Caregivers in the survey did not encounter high rates of COVID-19 infection among the pregnant women and newborns they cared for. However, they had to adjust to a large number of quickly changing medical protocols, to the general stressors of the pandemic and to greater levels of worry among their patients.

“In maternal and neonatal medicine, we’re on the front line, but we haven’t been hit by the hardest part of this pandemic,” Profit said. “It tells you what must be going on with the folks out there who are in other areas of medicine, such as those working in adult intensive care units.” Helping health care providers deal with burnout from the pandemic will require a large national response, he added.

Burnout linked to emotional exhaustion

Burnout among health care providers is characterized by feelings of emotional exhaustion and depersonalization. Individuals experiencing burnout also have increased rates of depression, alcoholism and suicidal ideation, as well as worse relationships with people in their lives. Prior studies have shown that health care workplaces with higher burnout levels have more problems with patient safety.

The study was conducted via an online survey offered to 673 health care workers who had participated in a webinar about mental health during the COVID-19 pandemic. The survey consisted of 13 questions about participants’ well-being and about patient safety in their workplaces. Participants’ level of emotional exhaustion was assessed using a previously validated five-question scale. The participants provided demographic information, including job title.

In total, 288 participants completed the survey. About one-third were from California. The rest were from other parts of the United States. The majority of responses (58.7%) came from nurses, with the rest from physicians (11.8%) and other health care professionals (29.5%).

Many elements of the responses indicated the toll of the pandemic: Besides the 66% of respondents who were emotionally exhausted and the 73% who felt their co-workers were increasingly burned out, 58% saw co-workers struggling to focus on work, 59% were themselves struggling to meet work and home responsibilities, 33% reported more unprofessional behavior, and 12% reported more medical errors. However, 70% were hopeful about the future, and 83% felt lifted up by their colleagues. In general, nurses reported more struggles than physicians.

Readying a response

More research is needed to understand how recent stages of the pandemic are affecting the well-being of health care providers, Profit said. Larger studies and data collected at multiple time points would help, he added. Neonatal intensive care units in California already have efforts underway to improve workplace culture. Such efforts previously have been shown to reduce burnout. But more will be needed to deal with the effects of the pandemic, Profit said.

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Tocilizumab cuts mortality risk in severely ill COVID-19 patients finds new trial conducted in India

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Tocilizumab, an anti-inflammatory drug used to treat rheumatoid arthritis, improves outcomes in severely ill COVID-19 patients, finds the results of a new trial conducted in hospitals across India—one of the world’s most ethnically diverse countries. Researchers from the University of Bristol and Medanta Institute of Education and Research in India who led the study, published in The Lancet Respiratory Medicine, say it adds to existing evidence supporting the drug’s use in critically ill patients.

Conducted in 12 public and private hospitals across India, the COVID India Tocilizumab (COVINTOC) phase 3 randomized controlled trial aimed to investigate whether tocilizumab could prevent disease progression and mortality in hospitalized patients with moderate to severe COVID-19.

The study team recruited 180 patients (age 18-years and over) who had been hospitalized with moderate to severe COVID-19. Of these, 89 patients were randomized to receive standard care, and 91 patients were randomized to receive standard care plus tocilizumab.

Patients were followed up over a 28-day period to record any clinical improvement markers and assess disease progression from moderate to severe or from severe to death. The team also recorded whether patients experienced adverse events, serious adverse events, and post-treatment infections, and requirement for renal replacement drugs.

Analysis of the data revealed a subset of patients with severe disease in whom tocilizumab might have a reduced risk for progression to death if treated with tocilizumab in addition to standard care. However, clinical parameters or biomarkers to reliably identify these patients and the optimal timing of treatment during COVID-19 progression remain unknown. The authors conclude that while the study does not support the routine use of tocilizumab in adults with COVID-19 it adds to the growing evidence suggesting it may help some severely ill patients.

The trial’s lead co-author, Professor A. V. Ramanan from the University of Bristol’s School of Clinical Sciences, and Consultant Paediatric Rheumatologist at Bristol Royal Hospital for Children, said: “Our study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies. It adds to existing evidence from the RECOVERY and REMAP-CAP studies which demonstrate that tocilizumab does have a significant impact on reducing mortality in those with COVID-19 requiring oxygen or being ventilated.

“After dexamethasone (steroids), this is still the most significant advance in the treatment of COVID that has an impact in reducing deaths.”

Lead co-author Dr. Arvinder Soin, Chairman of the Medanta Liver Transplantation Institute at Gurugram, India, said: “While there were no differences in mortality and the need for ventilation among the two groups of patients when moderate and severe categories of patients were considered together, a subgroup analysis of the severe patients in the two groups showed a lower mortality at 28 days (8/50; 16 per cent) among those who received tocilizumab compared to those who did not (14/41; 34 per cent). The reported adverse events did not differ between the tocilizumab and standard care arms.

“Given the conflicting results of the previous studies, millions were wasted last year on the indiscriminate use of tocilizumab, as the precise stage of the disease in which to use the drug was not clear. This study plugs an important gap in knowledge on COVID treatment and clarifies that tocilizumab should be administered to patients in the severe category. Incidentally, last month, two major studies from the UK—the RECOVERY Trial and the REMAP-CAP study—have revealed similar findings, that tocilizumab reduces mortality among patients with severe COVID-19.”

The trial was conducted against incredible odds across multiple sites under difficult conditions in a country that has the second highest COVID-19 caseload in the world.

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COVID-19 vaccine acceptance falling globally and in the U.S., survey finds

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The percentage of people globally who say they will get a COVID-19 vaccine has fallen in recent weeks, even as tens of millions of doses have been administered around the world, new survey data suggest.

The Johns Hopkins Center for Communication Programs, along with MIT, Facebook, and WHO, have been overseeing a global COVID behavior survey since July 2020 from nearly 1.7 million participants across 67 countries. The most recent data, drawn from more than 86,000 participants in 23 countries including the U.S., were collected in the two weeks ending February 1. The Center for Communication Programs is based at the Johns Hopkins Bloomberg School of Public Health.

After a slight increase to 66 percent of people saying they would get a COVID-19 vaccine at the beginning of January 2021, the average acceptance level across the 23 countries in this analysis fell to 63 percent. This overall decline comes amidst increased focus and media discussion on the rollout and access to COVID-19 vaccines. Broken down by country, the latest survey found that, in the final two weeks of January, vaccine acceptance declined in seven countries, remained similar in another seven, and rose in nine more.

Since March 2020, when WHO declared COVID-19 a pandemic, more than 112 million cases have been recorded and nearly 2.5 million people have died from it, according to Johns Hopkins University. More than 500,000 people have died from COVID-19 in the United States, the largest number of deaths in any country.

“We had hoped we would find that acceptance of COVID vaccines was on the rise in more countries, since vaccination is a critical part of ending the pandemic,” says CCP’s executive director Susan Krenn. “This means we have more work to do in helping people understand why getting vaccinated is so crucial to helping them, their families, and their communities.”

A key point to communicate is that a large percentage of people in a community need to be vaccinated in order to reach herd immunity, the level at which the spread of SARS-CoV-2—the virus that causes COVID-19—becomes difficult. Herd immunity levels vary depending on the infectiousness of a disease. Dr. Anthony Fauci, director the National Institute of Allergy and Infectious Diseases, has estimated that 70 to 85 percent of Americans need to be vaccinated to reach herd immunity for COVID-19. That threshold is much higher than the percentage of people in many countries reporting that they would be willing to get a vaccine.

The surveys leveraged Facebook’s reach of more than two billion global users, an average of 112,000 of whom participated in surveys roughly every 14 to 17 days since July. The questions have been about COVID-19 prevention behaviors such as mask wearing and social distancing, vaccine acceptance and trusted COVID influencers. This work has informed both global and national COVID-19 policies, and in the coming month the survey will evolve to include more countries and richer data to better describe global efforts to address the pandemic.

Of five countries in the Americas, the latest data found, only the United States saw a decline in vaccine acceptance in late January (from 69 percent to 65 percent). The other four countries— Mexico, Argentina, Brazil, and Colombia—saw an increase of five percentage points in vaccine acceptance. Argentina saw much higher acceptance rates among certain demographics. For example, in the most recent survey, acceptance rates in Argentina are higher among older (+18 percent), college educated (+12 percent), urban residents (+20 percent), and men (+5 percent) than they were two weeks earlier.    

The survey found that reported vaccine acceptance rates in European countries remained constant, with Italy and the United Kingdom well into the range of achieving herd immunity. Some countries (Italy, the UK, and Germany) have very low rates of reported non-acceptance (8 percent, 10 percent, and 13 percent, respectively). By contrast, respondents in Turkey and France are consistently among the lowest reported rates of vaccine acceptance within the 23 countries surveyed in this study: 24 percent and 56 percent, respectively.  

After a recent dip, acceptance levels in Nigeria are beginning to rise. Gender differences there continue to exist among participants, but since the last data collection period women’s acceptance rates increased 4 percentage points from 51 percent to 55 percent.

Along with the new data on vaccine acceptance rates, CCP released another wave of data about other COVID-19 prevention behaviors for the last two weeks in January. From the first survey in July, reported handwashing in the United States is down in every group except rural residents. Over the same period, reported mask wearing and physical distancing are up in the U.S. And while a smaller percentage of Americans report they have trust in scientists, they are still the most trusted sources of COVID-19 information.

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Deaths from food allergy rare and decreasing in the UK, finds study

food allergy

Deaths from serious allergic reactions (“anaphylaxis”) due to food have declined over the past 20 years, an analysis of UK NHS data had found. This is despite an increase in hospital admissions for food-induced anaphylaxis over the same time.

The analysis, conducted by scientists from Imperial College London and published in the BMJ also found that cows’ milk is the commonest single cause of fatal food-induced allergic reactions in school-aged children.

Around two million people are thought to live with a food allergy in the UK. Symptoms of an allergic reaction include an itching sensation inside the mouth, ears and throat, an itchy rash, and swelling of the face. In anaphylaxis, which can sometimes be fatal, a person can develop breathing difficulties, trouble swallowing or speaking. However, deaths from anaphylaxis are rare. It is estimated there are less than 10 fatalities due to food allergy per year in the UK.

Dr. Paul Turner, lead author of the study from Imperial’s National Lung and Heart Institute said: “This study raises two important points. The first is that despite hospital admissions increasing, the number of deaths from food-induced anaphylaxis has fallen. However, the second, more worrying point, is that cow’s milk is now the single most common cause of fatal allergic reactions in children. There is now a lot of awareness of allergies to peanut and tree nut, but many people think milk allergy is mild, perhaps because most children outgrow it. However, for those who don’t, it remains a big problem because milk is so common in our diet, and people don’t realise how dangerous it can be.”

The study, funded by the Food Standards Agency and Medical Research Council, analysed UK hospital admissions for food-induced anaphylaxis between 1998-2018, and how these compare to fatal anaphylaxis events.

Food Standard Agency ‘s Head of Policy and Strategy for Food Hypersensitivity, Sushma Acharya, said: “These important findings help us understand the trends of severe food induced allergic reactions, like who is most at risk and which foods are responsible. This research is part of a wider study we have commissioned to support our ambition for the UK to be the best place in the world to be a food hypersensitive consumer. We want to improve the quality of life for people living with food hypersensitivity and support them to make safe informed food choices.

“We note that young adults are most at-risk from severe and fatal allergic reactions to foods. Our upcoming promotion to encourage young people to ask for allergen information when ordering food is one example of how this valuable data will be used to inform our campaigns and policy making.”

The team at Imperial are now investigating why some people may be more susceptible to severe allergic reactions, and whether factors such as genetics may play a role.

During the study period from 1998 to 2018, hospital admissions for food-induced anaphylaxis increased by 5.7% per year, or three-fold (from 1.23 to 4.04 admissions per 100,000 population per year).

Over the same time, the case fatality rate (number of fatalities compared to hospital admissions) for food-anaphylaxis more than halved, from 0.7% in 1998 to 0.3% in 2018. This may be due to better awareness of food allergy, and how to quickly recognise and treat serious allergic reactions.

Deaths from food-induced anaphylaxis are rare. The study also assessed food-related anaphylaxis fatalities, recorded since 1992, when data first became available. There had been 187 fatalities since 1992 where the cause of death was likely to be food-induced anaphylaxis. At least 86 (46%) of these were due to peanuts or tree nuts such as almonds, cashews and walnuts.

Sixty-six deaths were reported in children, of which 14% were caused by peanuts, 9% by tree nuts and in 12% of cases, the nut could not be identified. However, the most common single cause of fatal anaphylaxis was cows’ milk, responsible for 26% of cases. Furthermore, there was a trend towards a greater proportion of reactions being caused by milk since 1992.

The research team add that cow’s milk is quite protein-rich, meaning a small amount of cow’s milk can result in a significant exposure.

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Study finds genetic clues to pneumonia risk and COVID-19 disparities

pneumonia

Researchers at Vanderbilt University Medical Center and colleagues have identified genetic factors that increase the risk for developing pneumonia and its severe, life-threatening consequences.

Their findings, published recently in the American Journal of Human Genetics, may aid efforts to identify patients with COVID-19 at greatest risk for pneumonia, and enable earlier interventions to prevent severe illness and death.

Despite the increasing availability of COVID-19 vaccines, it will take months to inoculate enough people to bring the pandemic under control, experts predict. In the meantime, thousands of Americans are hospitalized and die from COVID-19 each day.

“This study is so important because we performed analyses separately in participants of Caucasian ancestry as well as African ancestry to identify genetic risk factors contributing to pneumonia susceptibility and severity,” said Jennifer “Piper” Below, Ph.D., associate professor of Medicine and the paper’s corresponding author.

“Combined with systemic racism and socioeconomic factors that have been reported by others, these genetic risk differences may contribute to some of the disparities we observe in COVID-19 outcomes,” Below said.

The researchers conducted genome-wide association studies (GWAS) of more than 85,000 patients whose genetic information is stored in VUMC’s BioVU biobank and which has been linked to “de-identified” electronic health records stripped of personal identifying information. GWAS can identify associations between genetic variations and disease.

With colleagues from the University of North Carolina at Chapel Hill, the University of Texas MD Anderson Cancer Center in Houston, and the Icahn School of Medicine at Mount Sinai in New York, the VUMC researchers identified nearly 9,000 cases of pneumonia in patients of European ancestry, and 1,710 cases in patients of African ancestry.

The strongest pneumonia association in patients of European ancestry was the gene that causes cystic fibrosis (CF). This disease produces abnormally thick mucus leading to chronic infections and progressive respiratory failure.

In patients of African ancestry, the strongest pneumonia association was the mutation that causes sickle cell disease (SCD), a red blood cell disorder that increases the risk for pneumonia, influenza and acute respiratory infections.

Children with CF and SCD are at particular risk for severe disease if they contract COVID-19.

The researchers found that “carriers” who are unaffected by CF yet carry a copy of the CF gene had a heightened susceptibility to pneumonia, and those who are unaffected by SCD yet carry a copy of the SCD mutation were at increased risk for severe pneumonia.

Further studies will be needed to determine whether these carriers also bear “a silent, heightened risk for poor outcomes from COVID-19,” the researchers said.

To identify other genetic variations that increase pneumonia risk, they removed patients with CF and SCD from their analysis, repeated the GWAS, and used another technique called PrediXcan, which correlates gene expression data with traits and diseases in the electronic health record.

This time they found 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. The molecular function of R3HCC1L is unclear, but deletion of the UQCRFS1 in mice disrupts part of their infection-fighting immune response.

“Although our understanding about the genetic mechanism of pneumonia is still limited, this study identified the novel candidate genes, R3HCC1L and UQCRFS1, and offered an insight for further host genetic studies of COVID-19,” said the paper’s first author, Hung-Hsin Chen, Ph.D., MS, a postdoctoral fellow in Below’s lab.

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New trial finds arthritis drug tocilizumab no better than standard care for severe COVID-19

COVID-19, coronavirus

Adding the arthritis drug tocilizumab to standard care for patients in hospital with severe or critical COVID-19 is no better than standard care alone in improving clinical outcomes at 15 days, finds a new trial published by The BMJ today.

There was an increased number of deaths at 15 days in patients receiving tocilizumab, resulting in the trial being stopped early.

Today’s results contradict earlier observational studies suggesting a benefit of tocilizumab. However, observational effects are limited by a high risk that they may be due to other unknown (confounding) factors—and some studies have not yet been peer reviewed or published in a medical journal.

A randomised trial assessing tocilizumab in critically ill patients with COVID-19 (REMAP-CAP) published as a preprint earlier this month, found a beneficial effect of the drug on days free from organ support within 21 days and mortality. Reasons for these apparently contradictory effects, for example differences between patients’ characteristics, need to be assessed in future analysis, say the researchers.

Tocilizumab blocks a specific part of the immune system (interleukin 6) that can go into overdrive in some patients with COVID-19. Doctors think this might help lessen the body’s inflammatory response to the virus and avert some of the more dire consequences of the disease, but its effects are not well defined.

To test this theory, researchers based in Brazil conducted a randomised controlled trial comparing tocilizumab plus standard care with standard care alone in patients admitted to hospital with severe or critical COVID-19.

Their findings are based on 129 relatively young adults (average age 57 years) with confirmed COVID-19 at nine hospitals in Brazil between 8 May and 17 July 2020.

Patients were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two chemicals linked to inflammation in their blood.

Patients were randomly divided into two groups: 65 received tocilizumab plus standard care and 64 received standard care alone.

Other potentially important factors, such as underlying conditions and use of other medication, were taken into account and all patients were monitored for 15 days.

By day 15, 18 (28%) patients in the tocilizumab group and 13 (20%) in the standard care group were receiving mechanical ventilation or died.

Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group.

The increased number of deaths in the tocilizumab group raised safety concerns and the trial was stopped early. In both groups, deaths were attributed to COVID-19 related acute respiratory failure or multiple organ dysfunction.

The researchers point to some limitations including the small sample size, which affects the chances of detecting a true effect. However, results were consistent after adjusting for levels of respiratory support needed by patients at the start of the trial, suggesting that the findings withstand scrutiny.

As such, the researchers conclude that in patients with severe or critical COVID-19, “tocilizumab plus standard care was not superior to standard care alone in improving clinical status at 15 days and might increase mortality.”

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Study finds national data may be underestimating illicit drug use in young people

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A study published in Addiction suggests that the UK government’s current national population-based data may be understating illicit drug usage among young people by as much as 20 percent.

Researchers from the University of Bristol compared data from the Crime Survey England and Wales (CSEW) with that of the Bristol-based longitudinal health study Children of the 90s. They found that the estimate of lifetime drug use among young people was 20 percent higher in the Children of the 90s cohort than the CSEW data (40.6 percent in CSEW, compared with 62.8 percent in Children of the 90s).

The difference in lifetime illicit drug use between Children of the 90s and the CSEW was greatest for cannabis and powder cocaine, where the difference in prevalence was 23.2 percent and 16.9 percent respectively.

Senior author Dr. Lindsey Hines, Wellcome Postdoctoral Fellow at Bristol Medical School explains: “Reliable measures of illicit drug use are vital for developing effective policy and treatment programs, and the UK figures come from the Crime Survey England and Wales. We compared these data to that of the Children of the 90s longitudinal health study, and found significantly higher use of all illegal substances. The two data sets use very different methodologies to collect the data, which may be a contributing factor to these differences. The Crime Survey is a one-off face to face survey whereas Children of the 90s has a long-standing relationship of trust with their participants, who have completed postal questionnaires every year since they were teenagers. Our study suggests that this trusted relationship, built over decades with participants, could lead to young people reporting their drug use more accurately.”

Bristol’s Children of the 90s, also known as the Avon Longitudinal Study of Parents and Children (ALSPAC), is a long-term health-research project that enrolled more than 14,000 pregnant women in 1991 and 1992. It has been following the health and development of the parents and their children in detail ever since. Throughout their lives, biological, environmental and lifestyle data has been collected from participants through a series of detailed questionnaires and in-person clinic visits. The data for this study was obtained from questionnaires conducted when the participants were 24 years old, and that age range was matched for comparison with the national data.

Researchers also compared the prevalence of smoking and hazardous alcohol consumption from the Smoking Toolkit Study (STS) and Alcohol Toolkit Study (ATS) to see if the illegality of the substance had a bearing on results. They found there was no difference in tobacco use between Children of the 90s and STS (29.4 percent and 27.4 percent respectively), however 60.3 percent of Children of the 90s participants reported hazardous drinking at age 24, compared to 32.1 percent in the ATS.

Lead author Hannah Charles, Epidemiology Scientist at Public Health England said: “Findings from this study suggest that we are potentially underestimating illicit drug use among young people in the UK which has implications for how well we are able to support young people’s health and mental wellbeing and reduce the negative impact of drug use.

“We know the Children of the 90s participants have a high trust in the study and are used to talking about drug use because they have been asked questions on this topic since they were teenagers. However, as Children of the 90s participants are drawn from one region of the UK, we urgently need to expand this work to other longitudinal health studies (also known as birth cohort studies) to further validate the results. The nature of and illegality of drug use means that it is often a difficult area for researchers to get honest data. We’re not saying they are miss-reporting the levels, but rather that the methodologies could be complimented by other methods and validated using cohort studies, that could help to build up this trust.”

Nic Timpson, Principal Investigator of Children of the 90s health study commented: “Initially started to understand more about pregnancy and birth in the post-war years, there are now different longitudinal health studies across the UK. These health and social science studies have followed their participants throughout their lives, in many cases since their births. Their participants’ commitment and the data they collectively provide underpin important health research taking place around the world.”

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Clinical trial finds inhaled immune response protein increases odds of recovery for hospitalised COVID-19 patients

Hospitalised COVID-19 patients in the UK who received an inhaled form of interferon beta-1a (SNG001) were more likely to recover and less likely to develop severe symptoms than patients who received a placebo, according to a new clinical trial published in The Lancet Respiratory Medicine journal. This is the first evidence published in a peer-reviewed medical journal that inhaled interferon beta-1a could lessen the clinical consequences of COVID-19 and serves as proof-of-concept that this treatment could help hospitalised patients recover, but further research is required.

As the number of COVID-19 infections continues to rise around the world, there is a pressing need to develop new treatments for the more severe and life-threatening symptoms such as pneumonia and respiratory failure.

Interferon beta is a naturally occurring protein that coordinates the body’s immune response to viral infections. Laboratory studies have found that the SARS CoV-2 virus directly suppresses the release of interferon beta, while clinical trials demonstrate decreased activity of this important protein in COVID-19 patients. The formulation of interferon beta used in this new study—SNG001—is directly delivered to the lungs via inhalation and has been trialled in the treatment of asthma and chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the safety and efficacy of SNG001 to treat hospitalised COVID-19 patients.

The trial was conducted at nine UK hospitals with patients who had a confirmed SARS-CoV-2 infection. It compared the effects of SNG001 and placebo given to patients once daily for up to 14 days, and followed up patients for a maximum of 28 days after starting the treatment. Patients were recruited from March 30 to May 30, 2020, and were randomly assigned to receive the treatment or a placebo. All members of the research team were blinded to which group the patients were allocated. During the study, changes in the clinical condition of patients were monitored.

Of the 101 patients enrolled in the study, 98 patients were given the treatment in the trial (three patients withdrew from the trial) – 48 received SNG001 and 50 received a placebo. At the outset of the trial 66 (67%) patients required oxygen supplementation at baseline (29 people in the placebo group and 37 in the SNG001 group). Patients who received SNG001 were twice as likely to show an improvement in their clinical condition at day 15 or 16, compared with the placebo group.

In the placebo group, 11 (22%) of 50 patients developed severe disease (defined in this study as requiring mechanical ventilation) or died between the first dose and day 15 or 16, compared with six (13%) of 48 patients who received SNG001 (this includes three deaths in the placebo groups and none in the treatment group).

Over the 14-day treatment period, patients who received SNG001 were more than twice as likely to recover, compared to those in the placebo group—with 21 (44%) patients in the SNG001 group recovering compared with 11 (22%) patients in the placebo group (patients were deemed to have recovered when they were no longer limited in their activity). In a secondary analysis, the authors found that at 28 days, SNG001 patients were over three times more likely to recover than patients receiving placebo.

Lead author, Professor Tom Wilkinson from the University of Southampton, UK, says: “The results confirm our belief that interferon beta, a widely known drug approved for use in its injectable form for other indications, may have the potential as an inhaled drug to restore the lung’s immune response and accelerate recovery from COVID-19. Inhaled interferon beta-1a provides high, local concentrations of the immune protein, which boosts lung defences rather than targeting specific viral mechanisms. This might carry additional advantages of treating COVID-19 infection when it occurs alongside infection by another respiratory virus, such as influenza or respiratory syncytial virus (RSV) that may well be encountered in the winter months.”

The safety of inhaled interferon beta-1a was assessed by monitoring adverse events over 28 days. 26 (54%) patients in the SNG001 group and 30 (60%) patients in the placebo group had adverse events during treatment, with the most frequently reported being headache. Fewer patients in the SNG001 group had serious adverse events, compared with the placebo group.

The authors note some limitations of their study. The sample size was small and, as such, findings cannot be generalised to wider populations and healthcare settings. There were differences between the two groups at recruitment: patients in the SNG001 group had more severe disease at baseline and more patients had hypertension, and in the placebo group more patients had diabetes and cardiovascular disease. However, these factors were considered in the statistical model used, and beneficial signals for therapy were enhanced when a priori adjustments were made. Larger trials should be able to address these limitations with randomisation of more varied groups, according to the researchers.

The same research group is also assessing the effectiveness of the treatment in pre-hospital cases of COVID-19. To assess the treatment for patients who are critically ill and requiring mechanical ventilation, an alternative delivery method than the current nebuliser is needed.

Writing in a linked Comment, lead author Nathan Peiffer-Smadja (who was not involved in the study), from Assistance Publique—Hôpitaux de Paris, France, pointed out that preliminary results from the SOLIDARITY/DisCoVeRy randomised clinical trial in COVID-19 patients (which includes 8% who were mechanically ventilated) has so far failed to show efficacy of subcutaneous injectable interferon beta-1a. One potential explanation is because this route of administration doesn’t provide the targeted delivery of the drug to the lungs, which occurs with inhaled delivery. The Comment also highlights concerns that in severe COVID-19 patients the use of the drug could increase the inflammatory response and be associated with safety issues.

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