Articles: disease.
-
Randomized Controlled Trial Multicenter Study
A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part).
Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies of ensitrelvir have demonstrated promising results in treating mild-to-moderate COVID-19, evaluation of its clinical efficacy due to shifting vaccination status and emergence of the Omicron variant represents significant challenges. Here, we describe the protocol for a phase 3 study designed to evaluate the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19, regardless of risk status or vaccination history. ⋯ In a post hoc analysis of the phase 2b study, compared with placebo, ensitrelvir demonstrated a reduced time to resolution of 5 symptoms in patients with mild-to-moderate COVID-19. Through this study, we intend to validate and establish the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19.
-
Multicenter Study
Pulmonary embolism in COVID-19, risk factors and association with inflammatory biomarkers.
The coronavirus disease 2019 (COVID-19) pandemic affected millions of people worldwide resulting in a substantial number of hospitalizations. Venous thromboembolism including pulmonary embolism is a known complication of COVID-19 pneumonia although its incidence in such patients is unclear. In this multicenter retrospective cohort study, we looked at the incidence of pulmonary embolism in COVID-19 patients and its associations with various risk factors including demographics, comorbidities, inflammatory markers and coagulation profiles. ⋯ Patients admitted to the hospital for COVID-19 pneumonia had a relatively high incidence of pulmonary embolism. D-dimer was the only associated laboratory parameter associated with pulmonary embolism. However, further research is needed to evaluate its predictive and prognostic utility, particularly in an older population.
-
The frequency of acute kidney injury (AKI) in COVID-19 patients can be varied and related to worse outcomes in the disease population. AKI is common among hospitalized patients with COVID-19, particularly the ones needing critical care. This study was conducted in order to determine the outcomes of hospitalized patients with prolonged hospital stays who suffered from COVID-19 associated AKI. ⋯ The mortality rate was significantly higher with AKI (OR: 4.7, P < .001). Alongside AKI, concomitant liver dysfunction was also significantly contributing to mortality (OR: 2.5), apart from ICU stay (OR: 2.9), invasive ventilation (OR: 9.2), and renal replacement therapy (OR: 2.4). Certain laboratory markers were associated with AKI throughout in-hospital stay.
-
Randomized Controlled Trial Multicenter Study
Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial.
Rezafungin is a next-generation, once-a-week echinocandin in development for the treatment of candidaemia and invasive candidiasis and for the prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis spp after blood and marrow transplantation. We aimed to compare the efficacy and safety of intravenous rezafungin versus intravenous caspofungin in patients with candidaemia and invasive candidiasis. ⋯ Cidara Therapeutics and Mundipharma.
-
Randomized Controlled Trial Multicenter Study
Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL).
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs). ⋯ UCB Pharma.