Fayette

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. This condition involves kidney damage characterized by protein in the urine. The study is a combined Phase 2/3 adaptive, double-blind, placebo-controlled clinical trial sponsored by Vertex Pharmaceuticals Incorporated. Participants will be randomly assigned to receive different doses of VX-147 tablets or matching placebo tablets. They will take the assigned treatment for at least 96 weeks in Part A. Those who complete Part A will continue receiving VX-147 for an additional 96 weeks in Part B. The study uses a quadruple masking design to keep treatment assignments confidential. Throughout the study, participants will undergo regular assessments including urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) slopes to monitor kidney function. Safety is monitored by tracking adverse events and serious adverse events over several years. Blood samples will measure VX-147 levels, and treatment acceptability will be assessed in pediatric participants. Total participation may last up to approximately four years, with ongoing safety and efficacy evaluations.