This was conducted at five UK National Institute for Health and Care Research (NIHR) Clinical Research Facility (CRF) sites (in Liverpool, Manchester, Lancashire, Southampton and London), coordinated by the NIHR Southampton Clinical Trials Unit and sponsored by the University of Liverpool. The AGILE CST2 phase II trial ( NCT04746183) was designed as a double-blind, randomized, controlled Bayesian adaptive trial in adult early infection in the community with the primary objective to determine the ability of the recommended phase II dose (800mg orally 12 hourly for 5 days) of molnupiravir to improve viral clearance. 6 Here, we present the Phase II results in a detailed assessment of clinical outcomes and serial virological responses across a range of SARS-CoV-2 variants, including participants who were vaccinated and unvaccinated. The AGILE platform undertook a seamless phase 1b/2a evaluation of molnupiravir in the UK using a Bayesian adaptive design. While directly-acting antivirals are expected to remain effective, confirmation of continued efficacy against emerging variants is required. The shifting epidemiology of SARS-CoV-2 variants globally with the growing prevalence of the Omicron BA.2 lineage gives cause for concern, particularly with an anticipated loss of clinical effect of many monoclonal antibodies. Although NHC was positive in the Ames test, extensive study of molnupiravir in in vivo whole animal mutagenicity assays was reassuring. While these studies have shown molnupiravir to be generally well tolerated, longer term safety continues to be monitored during ongoing clinical studies and pharmacovigilance programs. Details on vaccination status of participants were not provided. Molnupiravir was also associated with a significantly higher rate of SARS-CoV-2 PCR-negativity after 5 days of treatment (77♱% versus 29♳%), and at days 10 (91♳% versus 70♲%) and 14 (93♹% versus 89♰%). Preliminary data presented at the 2022 Conference on Retroviruses and Opportunistic Infections from an open-label study from India of 1218 adults also reported a significant reduction in hospitalisations 3 (1♵% versus 4♳%) using a generic formulation of molnupiravir. We have previously reported an optimal dose of 800mg every 12 hours for 5 days of molnupiravir in adults with documented SARS-CoV-2 infection 1 within AGILE, the UK early-phase platform for experimental COVID-19 therapies [ MOVe-OUT, a double-blind, placebo-controlled trial in 1433 unvaccinated adults with at least one risk factor for severe COVID-19 illness, reported that molnupiravir decreased clinical progression as judged by hospitalisations and death 2 - the risk of hospitalization or death at day 29 was 6♸ percentage points lower with molnupiravir than with placebo at the interim analysis and 3♰ percentage points lower in the all-randomized analysis. You can use Oxygen XML Editor's API to provide custom editor variables and theirĮxpanded values using custom Java or Javascript code.Molnupiravir (EIDD-2801/MK-4482) is the first orally-available directly-acting antiviral licensed for treatment of high-risk individuals with mild-to moderate COVID-19. Used in all places where a predefined editor variable is. You can define your custom editor variables in the application Custom Editor Variables preferences page.Ī custom editor variable can contain as values other editor variables and can be Like this $ to access the current project folder and theĮditor variables will be automatically expanded before the external tool is Specify the Save as field to use editor variables Here are some examples: XML with XSLT based transformation scenario types If you edit such a scenario and go to the Output tab you can In these places to make the transformation scenario portable and thus to be able to Most transformation scenario types have lists of parameters and fields where you canĬonfigure the place where the output should be saved.
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