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22nd November 2021
Haematological cancer patients are still at an increased risk of severe COVID-19 infections despite receiving two vaccination doses. This is according to a preliminary analysis of a disease register by researchers from Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy.
In April 2020, the European Haematological Association – infectious Diseases Working Party, established an open, web-based registry, EPICOVIDEHA. This was designed with a view to collecting information on the epidemiology, risk factors and mortality rates among patients with haematological cancer, who became infected with COVID-19. This was considered necessary given how patients with these malignancies and therefore a dysfunctional immune system are at an increased risk of complications if infected with COVID-19. Published data from the registry on 3801 patients has already shown a mortality rate of 31.2%, of whom, 58% died due to COVID-19 and 13.1% due to a combination of their malignancy and COVID-19.
However, since the introduction of COVID-19 vaccines, it is likely that the mortality rate would have been substantially lower. As a result, the Italian team prospectively collected registry data on adults who were either partially or fully vaccinated and who developed breakthrough COVID-19 infections, to assess the efficacy of the vaccines among those with haematological cancer. The register was used to capture data on the underlying condition of the patients before infection with COVID-19, their malignancy and vaccination status and details of their infection, e.g., disease severity, hospitalisation and mortality. They deemed fully vaccinated individuals as those form whom the second vaccine dose was administered 14 days before COVID-19 symptom onset or a positive PCR test result.
The researchers identified 113 patients with COVID-19 episodes and which occurred among both partially and fully vaccinated individuals with a haematological cancer. The median age of the patients was 66 years (61.1% male) and the most common malignancies were chronic lymphoid leukaemia (24.8%) and non-Hodgkin lymphoma (31.9%) and slightly more patients had active (53.1%) compared to controlled disease (45.1%) before infection with COVID-19. In addition, 87 (77%) of patients were fully vaccinated. From a subset of 40 of these fully vaccinated patients, only 13 (32.5%) had mounted an antibody response to vaccination with the remaining patients (67.5%) deemed non-responders.
Overall, 79 (60.4%) of haematological cancer patients had a severe COVID-19 infection, with 66.4% hospitalised and 21.3% admitted to an intensive care unit. Thirty days post-COVID-19 infection, the overall mortality rate was 12.4% (14 patients) and 10 of the 14 died due to their underlying malignancy. Interestingly, there were no differences in mortality between partially or fully vaccinated individuals (15.4% vs 11.5%, partial vs full vaccination, p = 0.73) or in terms of whether patients were considered as responders or non-responders to vaccination.
While the authors recognised that this was preliminary data, they are continuing to recruit haematological caner patients and will draw further conclusions once more data becomes available.
Pagano L et al. COVID-19 in vaccinated adult patients with hematological malignancies. Preliminary results from EPICOVIDEHA. Blood 2021.
19th November 2021
The level of cancer diagnoses in young people fell during the first-wave of the COVID-19 pandemic but there was also an increased likelihood of admission to intensive for cancers diagnosed during the period. This was the finding from a study by researchers from Oxford University, UK who discussed their findings in a poster presentation at the National Cancer Research Institute conference.
The COVID-19 pandemic has had a major impact on cancer services in the majority of countries across the world. In the UK, a survey by Cancer Research UK in July 2020, found that 2 in 3 cancer patients reported that their cancer care had been impacted and that ratings of overall cancer care as ‘very good’ decreased from 75% ‘before lockdown started’ to 37% ‘after lockdown started’. Moreover, other research shows that in England, there were approximately 3.4 million fewer key diagnostic tests performed between March and August 2020 compared with the same period in 2019.
Given the likely impact of delays in diagnostics, the Oxford team were interested in determining how in England, the first wave of the pandemic affected childhood, teenager and young adult cancer incidence rates, diagnostic and treatment time-intervals and cancer-related intensive care (ICU) admissions. They used the QResearch database, which is derived from the anonymised health records of over 35 million patients. In addition, since QReseaerch is also linked to linked to hospital admission, mortality and cancer diagnoses data held with a disease register, it was possible for the researchers to make links between these three factors. For the present study, researchers focused on central nervous system (CNS) tumours, lymphomas, leukaemias, sarcomas and renal tumours in those aged up to 25 years of age. They compared the incidence of these cancer diagnoses between 1st February to the 15th August 2020 and compared their findings to the three preceding pre-pandemic years. As well as the number of diagnoses, the team also analysed the length of time before treatment started after diagnosis and whether or not these patients were diagnosed after being admitted to intensive care.
A total of 2607 cancer diagnoses were made from 1st January 2017-15th August 2020, with 380 during the pandemic. Overall, this represented a 17% reduction (95% CI -38% to – 6%) in the incidence-rate-ratio during the first wave of the pandemic. In particular there was a 38% (95% CI -52% to -21%)] decrease in CNS tumours and a 28% (95% CI -45% to -5%) reduction in lymphomas. Interestingly, the researchers observed that childhood cancers that were diagnosed during the pandemic were more than twice as likely to be associated with an ICU admissions (adjusted odd ratio, OR = 2.2, 95% CI 1.33 – 3.47).
The researchers also observed that the median time to diagnosis was not significantly different across the different time periods (+4.5 days, 95% CI -20.5 days to +29.5) and the median time to treatment was actually shorter during the pandemic (-0.7 days, 95% CI -1.1 to -0.30).
The authors concluded that the COVID-19 pandemic led to substantial reduction in the detection of cancer in young adults but was also associated with an increase in cancer-related ICU admissions. They suggested that this was probably due to more severe baseline disease at diagnosis and that overall, their findings demonstrate a clear disruption to cancer diagnostic pathways in this age group which need to be addressed urgently in the recovery phase of the pandemic.
Saatci D et al. The impact of the COVID-19 pandemic on cancer diagnostic pathways in children, teenagers and young adults: a cohort study in England. NCRI conference 2021
17th November 2021
Samples of breast milk obtained from women who had been either vaccinated or previously infected with COVID-19 contained antibodies capable to mounting a robust response to live virus. This was the conclusion of a study by researchers from the Division of Allergy and Immunology, University of Rochester, New York, US. Previous studies have shown that breast milk does not contain COVID-19 although while other work has suggested that the virus can be detected, it is present at very low levels and does not represent a risk for infection. Whether human milk contains COVID-19 antibodies is uncertain since, to date, only one study has addressed the immunogenic response in lactating women but this was against a pseudovirus rather than a live virus.
For the present study, researchers recruited two groups of women 18 years of age and older; an infected and vaccinated cohort. Eligible patients for the infection group were required to have had a PCR positive test result within the previous 14 days, whereas among the vaccination group, a previous COVID-19 diagnosis was an exclusion criteria. For this latter group, all women had received two vaccinations and were breast-feeding. Samples of breast milk were collected from the infected cohort on days 0, 3, 7, 10, 28 and 90 whereas for the vaccinated women, samples were obtained 18 days after the first and second vaccination doses and 90 days after the second dose. All samples from both cohorts were analysed for both Ig A and Ig G as well as for COVID-19 virus.
A total of 77 women, 47 of whom were in the infected group and 30 in the vaccinated group were included in the analysis. The mean age of the infection group was slightly lower than the vaccinated group (29.9 vs 33, infected vs vaccinated, p = 0.002). Samples from neither of the two groups contained COVID-19 although both cohorts demonstrated neutralising activity against COVID-19 which was slightly higher in the infected cohort.
Among the infected cohort, breast milk samples showed a robust and fast Ig A response that was stable at 90 days but a more variable Ig G response. In contrast, among the vaccinated cohort, levels of Ig A rose after the first vaccination but then decreased after the second dose and while Ig G levels were uniformly larger in response to vaccination but levels had declined by day 90.
Commenting on their results, the authors suggested that collectively, Ig A is the first antibody up-regulated in human breast milk in response to infection with COVID-19. In contrast, among vaccinated women, there is a larger Ig G response which increases after the first and second doses but which declines over time.
They concluded that both Ig A and Ig G contribute towards COVID-19 neutralising capacity and that this implies a clinical benefit to infants receiving breast milk from either previously infected or vaccinated mothers.
Young BE et al. Association of Human Milk Antibody Induction, Persistence, and Neutralizing Capacity With SARS-CoV-2 Infection vs mRNA Vaccination. JAMA Pediatr 2021
12th November 2021
The CHMP positive opinion for regdanvimab marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the European Medicines Agency (EMA).
The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the US, Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.
Rolling review of regdanvimab had been initiated by the EMA in February 2021 and the announcement of the CHMP positive opinion for regdanvimab follows the submission of a marketing authorisation application to the EMA seeking approval of regdanvimab in October 2021.
“The primary benefits of monoclonal antibodies are their high specificity and safety – they are highly specific for a single target, so these monoclonal antibodies rarely cause undesirable side effects,” said Oana Sandulescu, MD, PhD, Associate Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy in Romania. “An infusion of an hour of monoclonal antibodies like regdanvimab can ease COVID-19 symptoms and reduce complications in recently diagnosed, non-hospitalised people at high risk, and thus plays an important role in preventing further spread of the virus.”
2nd November 2021
Giving fluvoxamine to patients with one or more risk factors for severe illness in COVID-19, reduced the proportion of patients requiring more than 6 hours of emergency care when administered within 7 days of symptom onset. This was the conclusion of a study from researchers based at the Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil. Although vaccination against COVID-19 has become a priority across the globe, some work is continuing on the repurposing of existing medicines to treat the virus. One such drug is the antidepressant fluvoxamine which is an agonist for the sigma-1 receptor which is a chaperone protein at the endoplasmic reticulum with anti-inflammatory properties. In addition, a previous small trial in 152 patients with COVID-19, found that those given fluvoxamine had a lower likelihood of clinical deterioration over 15 days.
For the present study, researchers wanted to provide more robust evidence for the value of fluvoxamine in COVID-19. They performed a randomised, placebo-controlled trial among individuals who presented at an outpatient care setting with acute symptoms consistent with COVID-19 infection. All included patients had at least one additional risk factor for more severe illness e.g., diabetes, hypertension, symptomatic asthma etc., and a positive rapid antigen test for COVID-19. Individuals were then randomised 1:1 to receive fluvoxamine 100 mg twice daily for 10 days or matching placebo within 7 days of the onset of COVID-19 symptoms. The primary outcome was a composite endpoint of medical admission to a hospital setting due to COVID-19-related illness but who remained longer than 6 hours or who were hospitalisation due to progression of their illness within 28 days of randomisation. Several secondary outcomes were measured including hospitalisation for COVID-19, time to hospitalisation, number of days in hospital.
A total of 1497 patients with a mean age of 50 years (58% female) were randomised to either fluvoxamine or placebo. Overall, 180 patients assigned to fluvoxamine and 251 given placebo had any form of interaction with a COVID-19 emergency setting (relative risk, RR = 0.73, 95% CI 0.62 – 0.88). In the treatment group, 11% of participants compared with 16% in the placebo arm had the primary outcome event, of which 87% were hospitalisations, (RR = 0.69, 95% CI 0.53 – 0.90), giving a number needed to treat of 20 (i.e., 1/0.05).
There were no significant differences for any of the secondary outcomes, e.g., for hospitalisations ,the rates were 10% vs 13% (fluvoxamine vs placebo, p = 0.10). In addition, there 17 deaths in the treatment arm and 25 in the placebo group which was also non-significant.
The authors commented on how use of fluvoxamine for 10 days, was associated with a clinically important absolute risk reduction of the primary outcome. Furthermore, a limitation was the the study was undertaken before the more widespread availability of COVID-19 vaccines hence it remains unclear as to the effectiveness of fluvoxamine in those who have been vaccinated.
Reis G et al. Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial. Lancet Glob Health 2021
19th October 2021
Statin use appears to be associated with a lower mortality in those infected with COVID-19 according to the results of a large, Swedish cohort study. Previous studies in this area have been ambiguous. For example, a Danish observational study concluded that “recent statin exposure in patients with COVID-19 infection was not associated with an increased or decreased risk of all-cause mortality or severe infection.” In contrast, a US study observed a greater than 50% reduction in the risk of developing severe COVID-19 after controlling for co-morbidities and other treatments. Although a meta-analysis of studies on the use of statins and outcomes for COVID-19, concluded that the drug class was not associated with an improvement in a composite of poor outcomes, there was substantial heterogeneity with the included studies. While on-going trials examining the adjunctive value of statins will ultimately provide some much needed clarity of the possible benefit of this class of medicine, a team from the Department of Global Public Health, Karolinska Institute, Stockholm, Sweden, have published data from a large, population-based observational study, examining the relationship between statin use and COVID-19 mortality.
Using a prescribed drug registry, the team included individuals aged 45 years and older prescribed any type of statin between March 2019 and the end of February 2020. These individuals were followed-up until death from either COVID-19 or any other cause. For their study, the primary outcome of interest was death from COVID-19 and the analysis was presented as adjusted hazard ratios. Adjustments were made for numerous factors including age, gender, income, household crowding and wide range of co-morbidities.
A total of 963,876 individuals were included in the analysis. The cohort comprised, 169, 642 statin users with a median age of 71 years (43.4% female) with hypertension being the most common co-morbidity (74.3%). Overall, 2,545 individuals died from COVID-19 during the period of follow-up; 756 (0.5%) who were statin users, giving an adjusted hazard ratio for mortality of 0.88 (95% CI 0.79 – 0.97, p = 0.01) compared to non-statin users. This association did not differ by gender (p = 0.65), across age groups (p = 0.82) or COVID-19 risk groups (p = 0.72).
Although of course these data do not prove that statin use reduces death in those with COVID-19, it offers some tentative clues that individuals using these drugs appear less likely to die from infection with the virus. The authors concluded that the results provide some support for the continued use of statins during the COVID-19 pandemic.
Bergqvist R et al. HMG-CoA reductase inhibitors and COVID-19 mortality in Stockholm, Sweden: A registry- based cohort study. PLoS Med 2021
12th October 2021
The presence of continued symptoms after resolution of an acute infection with COVID-19 has become recognised and termed “Long-COVID“. For example, in one study, symptoms including fatigue or muscle weakness and sleep difficulties were the most common symptoms 6 months after the initial infection. Moreover, one small study with 83 patients, found that even after 12 months, radiological lung changes persisted in a quarter of patients. However, to date, there are no specific tools for an assessment of the ongoing symptom burden of COVID-19 although some evidence suggests that the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) may be of value. The CAT has been shown to provide some insight into the severity of symptom burden for patients following a hospitalisation for COVID-19 and might be of use in the assessment of ongoing symptoms following COVID-19.
In an attempt to determine the outcomes and symptom burden of patients with Long-COVID, a team from the Department of Respiratory Medicine, Daping Hospital, Chongqing, China, invited all adult patients with COVID-19 discharged from two hospitals in Wuhan, between February and April 2020, to participate in the follow-up study. Enrolled participants were interviewed by telephone and asked a series of questions on persistent symptoms as well as the CAT questionnaire, for which a score of 10 or more indicates a medium disease impact. Clinical and demographic data on each of the patients was obtained from electronic hospital records.
A total of 2,433 patients with a median age of 60 years (49.5% male), of whom, 27.9% had severe COVID-19 infection, were included in the analysis. At the one-year follow-up, 1338 (55%) of patients were completely symptom-free, with the remaining 45%, reporting at least one symptom. In addition, a patients hospitalised with more severe disease were more likely to report persistent symptoms (odds ratio, OR = 1.31, 95% CI 1.04 – 1.65, p = 0.02). The most common one-year follow-up symptoms were fatigue (27.7%), sweating (16.9%) and chest tightness (13%). The presence of fatigue was also more likely in those with a higher initial disease severity (OR = 1.36, 95% CI 1.10 – 1.68).
Among the 2,433 participants, the median CAT score was 2 although 6.6% had a CAT score greater than 10. As with persistent symptoms, more patients with severe infection had a CAT score > 10 (11.6% vs 4.7%, p < 0.01, severe vs non-severe infection). Furthermore, higher disease severity and co-existing cerebrovascular disease, were independent predictors of a CAT score > 10 (OR = 1.95, 95% CI 1.07 – 3.54, p = 0.03).
The authors concluded that their findings provided valuable information about the long-term health outcomes of COVID-19 survivors and risk factors for sustained symptoms and poor respiratory health status.
Zhang X et al. Symptoms and Health Outcomes Among Survivors of COVID-19 Infection 1 Year After Discharge From Hospitals in Wuhan, China. JAMA Netw Open 2021.
7th October 2021
As well as the physical health concerns raised during the COVID-19 pandemic, there has also been a recognised impact upon individual’s mental health due to several factors including social isolation, anxieties over contracting the virus and economic hardship. Although helicopter medical services (HEMS) are designed to attend to seriously ill and injured patients within the community, an analysis of the attendance of HEMS before and during the first wave of the COVID-19 pandemic, could be used to provide a measure of the mental health and well being of the population. This was the overall aim of a study undertaken in the East of England by researchers from the Department of Research, Audit, Innovation and Development, East Anglian Air Ambulance, UK. The researchers undertook a comparative, retrospective analysis of deliberate self-harm (DSH) incidents over two 61 day periods; March to 30 April 2019 (the control period) and between the same period in 2020 (COVID-19). The researchers looked at the overall activity of the HEMS during the two periods of time as well as the number of self-harm incidents. A self-harm incident was defined as “any act or self-poisoning or self-injury”, and severe self-harm as cardiac arrest and or death prehospital. The primary aim was to compare the incidence of deliberate self-harm incidents (DSH-I) before and during the first wave of the COVID-19 pandemic.
There were a total of 1725 HEMS activations; 981 during the control period and 744 during the COVID-19 period, which represented a 24.2% reduction in overall activity. However, during the COVID-19 period, there was an 11% increase in the number of DSH activations (73 vs 81, control vs COVID-19). For the primary outcome measure, there was a 65.4% increase in DSH-I encounters during the COVID-19 period compared with the control period. In fact, DSH-I encounters represented 9.5% of all activity during COVID-19 compared to 4.5% during the control period (odds ratio, OR = 2.3, 95% CI 1.40 – 3.7, p = 0.002). The increase was mainly due to hanging (17 vs 6, COVID-19 vs control) and falls from height (10 vs 3) although these differences were not statistically different.
The authors concluded that although the overall level of HEMS activity was lower during the COVID-19 period, the pandemic appeared to result in a nearly two-thirds increase (65%) in the number of DSH-I.
1st October 2021
Throughout the COVID-19 pandemic, several important risk factors for more severe disease have become apparent including male sex, increased age and cardiovascular co-morbidities. Whether or not being a current smoker affects COVID-19 outcomes is less clear with some analyses indicating a higher risk of worse outcomes, whereas others reviews suggest a reduced risk . One solution to untangling this ambiguity is the adoption of a dual analytical approach to data analysis, for example, by comparing the results from observational studies with those from a Mendelian randomisation study. In a Mendelian randomisation (MR) study, the underlying assumption is that a genetic variant influences only the variable of interest and since genetic variants are randomly allocated at birth, MR is less susceptible to confounding which is a problem in observational studies. Genetic analysis can be used to identify variants associated with particular traits. For example, tobacco and alcohol use are known to have heritable behaviours and in one study, researchers identified 566 genetic variants in 406 loci associated with multiple stages of tobacco use, e.g., initiation, cessation, and heaviness (i.e., the number of cigarettes smoked per day).
Using a dual analytical approach to examine the relationship between smoking and outcomes in COVID-19, a team from the Nuffield Department of Primary Care Health Sciences, University of Oxford, UK, turned to data held within the UK Biobank. The researchers separately explored the relationship between smoking and COVID-19 using findings from both observational studies and Mendelian randomisation. For the MR study, researchers used established genetic proxies for smoking initiation and smoking heaviness (i.e., the number of cigarettes smoked per day). The results were analysed using multivariate logistic regression analysis adjusted for several variables including age, sex, ethnicity and several co-morbidities.
For the observational analysis, there were 421,469 individuals with a median age of 68.6 years (55.1% female). Current smokers were found to have an overall higher risk of hospitalisation (adjusted odds ratio, aOR = 1.80, 95% CI 1.26 – 2.29) and mortality (aOR = 4.89, 95% CI 3.41 – 7.0).
Similarly, in the Mendelian randomisation analysis, genetic propensity to initiate smoking was associated with a higher risk of hospitalisation (aOR = 1.60, 95% CI 1.13 – 2.27), but not mortality (aOR = 1.35, 95% CI 0.82 – 2.22, p = 0.23). For genetically predicted higher number of cigarettes smoked per day, the risk of hospitalisation was also higher (aOR = 5.08, 95% CI 2.04 – 12.66) and risk of death (aOR = 10.02, 95% CI 2.53 – 39.72).
Discussing their findings, the authors said that this was the first study to adopt a dual analytical approach to assess the relationship between smoking and outcomes from COVID-19. They concluded that the congruence between the two methods indicated that a lifelong predisposition to smoking and smoking heaviness supported a causal effect (found in the observational analysis) of smoking on COVID-19 severity.
Clift AK et al. Smoking and COVID-19 outcomes: an observational and Mendelian randomisation study using the UK Biobank cohort. Thorax 2021
30th September 2021
According to the Centers for Disease Control and Prevention in the US, the risk of infection, hospitalisation and death from COVID-19 among US citizens is higher among ethnic minorities compared their White counterparts. The introduction of COVID-19 vaccines has resulted in a significant reduction in the risk of severe illness, hospitalisation and death. However, not everyone has embraced the need for COVID-19 vaccination with one study finding that among those of Black ethnicity, vaccine hesitancy levels were 5-times higher than their white counterparts. Moreover, vaccine hesitancy is also a recognised problem among parents, with a 2019 study showing that a quarter of parents reported hesitancy over childhood influenza vaccination. With US data indicating that 22% of the population is under the age of 18, there is an urgent need to ensure that children receive a COVID-19 vaccine and therefore increase the levels of community protection against the virus.
But given the existence of vaccine hesitancy, a team from the Division of Advanced General Pediatrics and Primary Care, Ann & Robert H. Lurie Children’s Hospital, Chicago, US, sought to understand, through an online, cross-sectional survey, not only the levels of vaccine hesitancy but how this was influenced by ethnicity and sociodemographic factors. The survey was conducted with parents who had children under 18 years of age and captured information on demographics, race, family income and the type of child insurance (e.g., public or private) as well as sources of information on COVID-19 using a defined list such as friends/word of mouth, internet, social media etc. COVID-19 vaccine hesitancy was measured from the question, “if a new vaccine against COVID-19 became available, how likely would you be to get your child vaccinated?” Responses were dichotomised as vaccine amenable or vaccine hesitancy for those responding “not likely” or “not sure” and this served as the outcome of interest. In their regression analysis, the authors examined the association between hesitancy and ethnicity, adjusting for parental race, household income, child insurance type and sources of information in which parents reported confidence.
A total of 1425 usable responses were obtained with 40% self-reporting as non-Hispanic White, 24% non-Hispanic Black and 27% as Hispanic (any race). Overall, 33% of parents reported COVID-19 vaccine hesitancy for their child. This was highest among non-Hispanic Blacks (48%) and lowest among non-Hispanic Whites (26%). The most common source of information on COVID-19 was the internet (67%). The authors calculated that non-Hispanic Black respondents had a significantly higher odds of COVID-19 vaccine hesitancy for their children compared to non-Hispanic White parents (adjusted odds ratio, aOR = 1.75, 95% CI 1.28 – 2.39, p < 0.001). In addition, parents on the lowest income also had a higher odds of hesitancy (aOR = 2.86) as did those having public insurance for their child (aOR = 1.33).
In discussing their findings, the authors commented on how non-Hispanic Black parents, with lower incomes and public health insurance had the highest levels of vaccine hesitancy. They concluded that given how this demographic had been most adversely affected by the pandemic, efforts to improve the dissemination of information about the COVID-19 vaccine should be culturally tailored to reduce disease burden in theis patient group.
Alfieri NL et al. Parental COVID-19 vaccine hesitancy for children: vulnerability in an urban hotspot. BMC Public Health 2021