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Press Releases

Take a look at a selection of our recent media coverage:

Molnupiravir halved risk of hospitalisation for patients with COVID-19

6th October 2021

Molnupiravir, an investigational anti-viral agent, has been shown to reduce hospitalisation in patients with COVID-19.

According to an interim analysis, Merck and Ridgeback’s investigational anti-viral drug, molnupiravir (MPV), halved the risk of hospitalisation in patients with mild-to-moderate COVID-19. MPV is a pro-drug that is incorporated by RNA polymerase into COVID-19 and which has been shown in preliminary studies, to reduce nasopharyngeal COVID-19 infectious virus and viral RNA.

The results come from the Phase III MOVe-OUT trial, designed to evaluate the safety, tolerability and efficacy of MPV in non-hospitalised patients with COVID-19. Enrolled patients had laboratory-confirmed mild-to-moderate COVID-19 and with an onset of symptoms within 5 days of study randomisation. In addition, all patients were required to have at least one risk factor associated with poor disease outcome. A second trial, examined the value of MPV in hospitalised patients although this was halted after it became apparent that molnupiravir was unlikely to demonstrate a clinical benefit in hospitalised patients.

MOVe-OUT is evaluating molnupiravir at a dose of 800mg twice daily and while the results are yet to be published, the interim analysis seems positive. According a joint press release from the companies, 7.3% (28/385) of patients receiving MPV were either hospitalised or died through to Day 29 following randomisation (28/385), compared with 14.1% (53/377) of placebo-treated (p=0.0012). In addition, after 29 days, there were no deaths were reported in patients who received MPV compared to 8 deaths in the placebo arm.

The incidence of drug-related adverse events was shown to be comparable (12% and 11% MPV vs placebo). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

Merck plans to submit an application for Emergency Use Authorisation (EUA) to the FDA as soon as possible and plans to submit marketing applications to other regulatory bodies worldwide.

Source: Merck and Ridgeback press release, October 2021

Similar factors associated with COVID-19 severity in children and adults

21st September 2021

A US study has found that as with adults, the same clinical factors affect COVID-19 severity and hospitalisation in children and adolescents.

The available evidence clearly shows that infection with COVID-19 is disproportionately higher in adults compared with children. Nevertheless, emerging data suggests that in children infection with COVID-19 can induce multisystem inflammatory syndrome and lead to serious illness. While the pandemic has revealed how several clinical factors such as older age, various co-morbidities and ethnicity, are all associated with a higher level of COVID-19 severity, much less is known about which factors lead to more severe disease in children.

This lack of information prompted a group of US researchers from the Division of Hospital Medicine, Monroe Carell Jr, Children’s Hospital, Vanderbilt, Nashville, Tennessee, US, to undertake a retrospective cohort study across 45 US children’s hospitals to assess factors associated with COVID-19 severity in paediatric patients. The researchers included patients as young as 30 days old to 18 years of age, discharged from either an emergency department (ED) or inpatient setting with a primary diagnosis of COVID-19. The researcher collected demographic data and information on the presence of any co-morbidities, particularly those which appeared to result in a worse prognosis among adults. The outcome of interest was COVID-19 severity which was categorised as mild (i.e., ED discharge), moderate (in-patient admission) and severe (intensive care (ICU) admission) and very severe (ICU admission with mechanical ventilation, shock or death). The results were analysed using regression analysis and presented as odds ratios adjusted for various factors including ethnicity and co-morbidities.

Findings
The study included 19,976 ED encounters of children with a median age of 6 years (51.2% male) with the most common ethnicities being Hispanic (48.8%) and non-Hispanic White (21.1%). In the majority of cases (79.9%) COVID-19 severity was mild (79.7%) and these individuals were discharged from the ED. However, among the 4063 (20.3%) patients who were hospitalised, the majority had moderate COVID-19 severity (79.3%) with 11.3% classed as severe and 9.4% as very severe. When compared with those who were discharged from the ED, the clinical factors associated with an increased odds of hospitalisation included obesity/type 2 diabetes (adjusted Odds ratio, aOR = 10.4, 95% CI 8.90 – 13.3), asthma (aOR = 1.40, 95% CI 1.3 – 1.60), cardiovascular disease (aOR = 5.0), an immunocompromised condition (aOR = 5.9) and pulmonary disease (aOR = 3.2). Only Black ethnicity impacted on the risk of hospitalisation compared to those of White ethnicity, (aOR = 1.52, 95% CI 1.20 – 1.93). With respect to age, compared to children aged 0 – 4 years, the risk of hospitalisation was lower among those aged 5 – 11 years (aOR = 0.50, 95% CI 0.45 – 56) and 12 – 17 years (aOR = 0.75, 95% CI 0.69 – 0.82). However, once hospitalised, the risk of higher COVID-19 severity increased in both groups: 5 – 11 group (aOR = 2.66) and 12 – 17 years (aOR = 2.09).
The authors concluded that while older children were at a lower risk of hospitalisation with COVID-19, once hospitalised, they appeared to be a higher risk of more severe disease. In addition, as with adults, similar co-morbidities were associated with a greater risk of hospitalisation and higher COVID-19 severity once admitted.

Citation
Antoon JW et al. Factors associated with COVID-19 disease severity in US children and adolescents. J Hosp Med 2021

Over 1 in 10 COVID-19 infections were hospital-acquired

16th August 2021

An analysis of COVID-19 infections during the first wave has revealed that just over 1 in 10 of these infections were hospital-acquired.

During the first wave of the COVID-19 pandemic there were a huge number of patients admitted to hospital. Ensuring minimal hospital-acquired infection was therefore of paramount importance, especially as earlier research with SARS and MERS had shown that human-to-human transmission occurred mainly within the healthcare setting. In a letter to the Lancet, a team from Lancaster Medical School, Lancaster University, UK, have examined the extent to which nosocomial, i.e., hospital-acquired, COVID-19 infections occurred during the first wave of the pandemic. The researchers used records contained in the International Severe Acute Respiratory Emerging Infection Consortium (ISARIC) and which has already reported on the clinical characteristics of 20,133 hospital in-patients during the initial phase of the pandemic. For the current analysis, the team examined records of patients enrolled in the UK arm of ISARIC and who had an onset of symptoms before the beginning of August 2020. In trying to determine whether patients were likely to have a hospital-acquired infection, the team considered both their admission date and the date of symptom onset. They used the recorded infection date for a patient and identified those who were admitted before infection, as likely candidates for a hospital-acquired infection.

Findings
The researchers estimated that there were 82,624 patients admitted to hospital before the beginning of August 2020 and found that 11.3% (95% CI 11.1 – 11.6) of these became infected with COVID-19 after admission to hospital. When restricting their analysis to the middle of May 2020, this proportion increased to 15.8% (95% CI 15.8 – 19.6). Using a more conservative estimate of symptom onset at least 14 days after hospital admission, the proportion reduced to 6.8%. An interesting additional finding was how there was marked heterogeneity between hospital trusts. For example, in cases where the trust provided both acute and general care, the incidence of infections was 9.7% (95% CI 9.4 – 9.9) whereas this was substantially higher in residential community care hospitals (61.9%, 95% CI 56.4 – 68) and in mental health hospitals (67.5%). The authors were unable to account for this extreme variation and called for an urgent investigation to identify and promote best practice for infection control.
In discussing these findings, they identified that a recognised limitation of the ISARIC dataset was that it was unable to identify patients infected during admission or those who were discharged before developing symptoms and who might have acquired their infection within the hospital. In other words, the authors felt that their overall estimate of the nosocomial infection rate is probably an underestimate. The concluded that with lessons learnt from the first wave coupled with the development of vaccines, NHS infection control policies should now be sufficiently robust to prevent the burden of hospital-acquired infections.

Citation
Read JM et al. Hospital-acquired SARS-CoV-2 infection in the UK’s first COVID-19 pandemic wave. Lancet 2021

Study shows nearly half of hospitalised patients had COVID-19 complications

19th July 2021

Among hospitalised patients, virtually half had COVID-19 complications, and which are likely to impact on future health services.

The mortality rate from infection with COVID-19 is high at approximately 26% and it has also become recognised that COVID-19 complications can occur in a large number of patients. Information on the incidence and type of COVID-19 complications is important for both patients and healthcare providers. For instance, patients need to know the likely time course of any complications whereas healthcare providers require this data to help with resource allocation and long-term planning for the delivery of services. Moreover, a sizeable number of patients with COVID-19 are admitted to intensive care units and while mortality is widely used as an outcome measure in many of the COVID-19 clinical trials, it fails to adequately capture the fact that survivors experience significant morbidity upon discharge.

A better understanding of the range and incidence of COVID-19 complications among those who are critically ill with the virus, is therefore critical to an assessment of the long-term burden on healthcare systems. In an effort to determine the range and prevalence of immediate complications of infection with COVID-19, a team from the Centre for Medical Informatics, Usher Institute, Edinburgh, Scotland, undertook a prospective, multi-centre cohort study in 302 UK which included adults, aged 19 years and older, with confirmed COVID-19 and admitted to hospital. Data was captured upon admission and after days 1, 3 and 9 and at discharge or the patient’s status after 28 days and included demographics and co-morbidities. The team set the primary outcome as the incidence of in-hospital complications and which was defined as organ-specific diagnoses occurring alone or in addition to any hallmarks of COVID-19 illness.

Findings
A total of 75,276 patients were included in the analysis with a mean age of 71.1 years (56% male) and with the majority (73.5%) being of white ethnicity. The existence of one or more comorbidities was present in 81% of participants. and the overall rate of COVID-19 complications was 49.7%. The most common complications reported affected the renal system (24.3%), systemic effects (16.3%), gastrointestinal (10.8%), cardiovascular (12.3%), neurological (4.3%) and respiratory (18.4%). Males aged 60 years and over, suffered the highest rate of complications (54.5%) although COVID-19 complications were common across all demographics. For example, among patients aged 19–29 years and without any comorbidities, 21.1% experienced at least one complication, whereas in those aged 50 years and older, the complications occurred in 51.3% of patients. Interestingly, among patients who survived 28 days from first symptoms to discharge, 44% suffered complications and 26.6% of whom, had a worse ability to self-care than prior to their illness.

In discussing their findings, the authors noted the high level of complications experienced by survivors. The most common were renal and in particular acute kidney injury which is known to be associated with substantial long-term morbidity. They also remarked upon how COVID-19 complications had developed in young and previously healthy individuals and how such complications are known to have a negative impact on long-term morbidity.

Citation
Drake TM et al. Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study. Lancet 2021.