Betim

Researchers are investigating the safety and effectiveness of Dato-DXd combined with osimertinib or alone compared to platinum-based doublet chemotherapy in treating adults with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase III, open-label study includes participants whose disease has worsened despite prior osimertinib treatment. The goal is to evaluate progression-free survival (PFS) over up to 2.5 years. Participants are randomly assigned to one of three groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd and chemotherapy drugs (pemetrexed, carboplatin, or cisplatin) are given by intravenous infusion, while osimertinib is taken orally. Treatment continues until the cancer progresses based on imaging, unacceptable side effects occur, or other reasons require stopping treatment. After stopping the study drugs, participants will have an end-of-treatment visit within 35 days and safety follow-up about one month later. During the trial, researchers will monitor participants with radiological scans and assess progression-free survival. Safety evaluations will continue after treatment ends to detect any side effects. The study includes adults aged 18 to 130 years with good performance status and adequate organ function who have progressed on prior osimertinib therapy. The total study duration includes treatment and follow-up periods to ensure thorough assessment of treatment effects and safety.

Researchers are evaluating several repurposed therapies including Fluvoxamine plus Budesonide, Fluoxetine plus Budesonide, and Spirulin Platensis to treat patients with early-onset COVID-19 who have mild symptoms but are at high risk for complications. This phase 3, double-blind, randomized, placebo-controlled study aims to assess if these treatments can reduce emergency care visits, hospitalizations, and oxygen desaturation events related to COVID-19 progression. The study builds on observational and experimental evidence suggesting these agents may have anti-inflammatory effects beneficial in early SARS-CoV-2 infection. Participants receive one of the study treatments or placebo following specific dosing schedules: Spirulin Platensis is given as two tablets every 12 hours for 10 days; Fluvoxamine plus Budesonide involves Fluvoxamine tablets every 12 hours and Budesonide inhalation every 12 hours for 10 days; Fluoxetine plus Budesonide is administered as Fluoxetine tablets daily plus Budesonide inhalation every 12 hours for 7 days. Placebo groups receive matching oral and inhalation placebos or paracetamol as an active comparator. The study includes adaptive modifications such as the addition of new treatment arms and changes to primary endpoints. During the 28-day follow-up, participants are monitored for emergency visits due to worsening COVID-19, hospitalizations related to disease progression, and oxygen saturation levels. Researchers evaluate safety and treatment effects through clinical assessments, laboratory tests, and symptom tracking. Participants must consent to treatment and follow study procedures, with ongoing monitoring for adverse events and protocol adherence throughout the study period.