Trujillo Alto

This research aims to learn about the safety, how the body processes, and how well the study medicine called nirmatrelvir/ritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but are at risk for severe illness. The study focuses on pediatric patients confirmed to have COVID-19, with early symptoms and risk factors for worsening disease. Participants will receive the study medicine, which is given by mouth, to evaluate its effects. The trial is open-label, meaning both researchers and participants know the treatment being given. The study is designed as a single-arm Phase 2/3 trial conducted at multiple centers. During the study, researchers will measure medicine levels in the blood at specific times to understand drug absorption and processing. They will monitor for any side effects or adverse events up to 34 days after starting treatment. Vital signs and other health indicators will be regularly checked to assess safety and overall health. The total participation period includes treatment and follow-up to gather comprehensive safety and effectiveness data.

Researchers are evaluating the safety and effectiveness of up to two injections of REACT/rilparencel in adults with type 2 diabetes mellitus and chronic kidney disease. This phase 3 randomized controlled study divides participants into two groups to compare the effects of the actual treatment versus sham procedures mimicking kidney biopsy and injections. The goal is to monitor kidney function and clinical outcomes over time to understand the impact of this therapy on disease progression. Participants are randomly assigned before a kidney biopsy to either receive sham procedures or the real treatment involving a kidney biopsy followed by two rilparencel injections about 12 weeks apart, each into different kidneys. Those receiving sham procedures will undergo similar-sounding and looking activities without actual tissue removal or injection. All participants will be followed until the study's global end date, ensuring consistent long-term observation. During the study, participants will undergo kidney biopsies or sham procedures, followed by injections or sham injections. Researchers will assess kidney function by measuring the slope of estimated glomerular filtration rate (eGFR) over 18 months after the 135th participant's first injection or sham procedure. They will also track clinical events such as significant kidney function decline, need for dialysis or transplant, or renal and cardiovascular deaths for up to 94 months. Safety and efficacy will be monitored throughout the study to evaluate treatment impact.