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6th October 2021
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.
3rd June 2021
Data have suggested that the risks of adverse outcomes among children infected with COVID-19 are far less than those of adults. Moreover, the classic COVID-19 symptoms such as cough and fever has been found to occur in only half of children infected with the virus. With the reopening of schools and the subsequent increased risk of community transmission, a team from the Division of Cardiovascular Disease, University of Alabama, Alabama, US, investigated the clinical characteristics of children infected with COVID-19 using information derived from a multi-centre healthcare network electronic health database. The authors included paediatric patients with a positive PCR test, aged < 18 years and stratified the population based on their age and ethnicity. Information was also included on past medical history and if hospitalised, whether individuals required mechanical ventilation or other forms of critical care. The PCR positive individuals were propensity matched on sex and ethnicity.
The retrospective analysis included 12,306 children, 672 (5.5%) of whom were hospitalised with a mean age of 9 years (51% male). Interestingly, only 25.1% of the sample had at least one of the classic COVID-19 symptoms (i.e., fever, cough or shortness of breath). The range of symptoms observed included respiratory symptoms (16.5%) such as cough or dyspnoea, gastrointestinal symptoms (13.9%) e.g., nausea, vomiting, skin rashes (8.1%) non-specific symptoms (18.8%) including fever, malaise, myalgia or disturbances of taste and smell. Among those hospitalised, 17.6% required critical care and 4.1% mechanical ventilation and there were fewer than 10 deaths. The risk of hospitalisation was higher in non-Hispanic black children compared with those of white ethnicity (relative risk, RR = 1.97 95% CI 1.49 – 2.61).
The authors described how they had observed a wide range of non-specific clinical symptoms and that only a quarter of those with a positive PCR test actually had the classic COVID-19 symptoms. They suggested that this warranted a need for increased vigilance among healthcare professionals when seeing school-aged children who might be infected with the virus. They concluded that while children can develop severe illness after infection with COVID-19, fortunately this is uncommon.
Parcha V et al. A retrospective cohort study of 12,306 pediatric COVID?19 patients in the United States. Sci Rep 2021