Kolin 2

Researchers are investigating adults aged 18 to 80 years who have sepsis caused by a suspected or confirmed bacterial infection and have developed acute kidney injury within 72 hours of sepsis onset. This Phase IIa, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, and effectiveness of the drug AZD4144 compared to a placebo in improving kidney function in participants with sepsis-associated acute kidney injury (SA-AKI). Participants will be randomly assigned to receive either intravenous AZD4144 or a matching placebo once daily during the treatment period, which lasts the number of days specified in the study protocol. The study includes a screening period, the treatment period with daily drug administration, and a follow-up period that involves daily assessments while hospitalized and up to two outpatient visits after discharge. During the study, participants will undergo daily safety monitoring, blood and urine sample collection, and other assessments to track kidney function and overall health. The main outcome measured is the area under the curve (AUC) of 24-hour creatinine clearance during the treatment period. Researchers will continue to monitor participants for safety and recovery during hospitalization and follow-up visits, ensuring comprehensive evaluation of the treatments over the entire study duration.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating which of three eye drop medications—bromfenac 0.09%, nepafenac 0.3%, or diclofenac 0.1%—works best to treat and prevent cystoid macular oedema following cataract surgery. The study focuses on comparing the effectiveness of these drugs in preventing macular swelling and examining any medical issues participants may experience while using them. This trial involves adult patients who need cataract surgery and no other eye surgeries during the procedure. Participants will be randomly assigned to use one of the three drugs during the period before and after their cataract surgery. Bromfenac is given twice daily, nepafenac once daily, and diclofenac four times daily. After surgery, participants will return to the clinic for check-ups on the first day, after one week, three weeks, and six weeks to monitor progress and treatment effects. During these visits, researchers will perform retina examinations using optical coherence tomography (OCT), assess the best vision in each eye, and ask participants to complete quality of life questionnaires. The main outcome measured is the presence of cystoid macular oedema from enrollment through six weeks of treatment. Safety and vision outcomes will also be carefully monitored throughout the study period.

Overactive bladder (OAB) is a common health issue affecting many adults, with about 15-20% of the population experiencing it. This research aims to increase awareness and ensure that people with OAB symptoms are correctly referred to specialists such as gynecologists, urogynaecologists, or urologists for proper diagnosis and treatment. The study uses an online screening tool to identify individuals who might have OAB and need specialist evaluation. Participants will use a web platform or mobile app to complete validated questionnaires about their urinary symptoms, personal and family medical history, and quality of life. Those with positive screening results will be referred to a specialist who can access their screening data through the platform, perform further diagnostic tests if needed, confirm or rule out OAB, and decide on appropriate treatment. The study also includes a public relations campaign to encourage participation and improve awareness. During the study, participants will complete the online screening and may attend face-to-face specialist visits for diagnosis. Researchers will monitor the number of participants who complete the screening, the percentage of those with suspected OAB agreeing to follow-up, those diagnosed by specialists, and those who attend follow-up visits up to nine months. The data collected will help evaluate the screening process and its impact on quality of life, with attention to safety and privacy under GDPR.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in adults hospitalized with severe community-acquired pneumonia (sCAP) who require invasive mechanical ventilation. This phase III, randomized, placebo-controlled, double-blind, multi-center trial aims to compare trimodulin plus standard care against placebo plus standard care. The study also includes substudies to understand the pharmacokinetics and pharmacodynamics of trimodulin. Participants will be randomly assigned to receive either trimodulin or placebo via intravenous infusion once daily for five consecutive days alongside standard care. After the treatment phase, patients will be followed for up to 23 days, with an end-of-follow-up visit or telephone call on day 29. For those still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a final visit or call on day 91. During the study, participants will undergo various assessments including monitoring of mortality rates up to day 29, clinical evaluations, and safety monitoring. Researchers will collect data on inflammation markers and other health parameters. Follow-up contacts and visits will ensure ongoing evaluation of patient status and adverse events throughout the study period, which may last up to 91 days or longer depending on hospital discharge timing.