Podgorica

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

Researchers are evaluating an intravenous human plasma-derived C1 esterase inhibitor C1-INH concentrate in people with congenital C1-INH deficiency who experience acute hereditary angioedema attacks. This phase 3, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of this treatment both for managing attacks and preventing attacks before medical procedures. Participants receive either OCTA-C1-INH, a purified concentrate of human C1-INH given as a slow intravenous injection at a dose of 20 IUkg body weight, or a placebo injection of saline solution. The treatment is administered after the first qualifying angioedema attack. Both blinded and open-label participants receive OCTA-C1-INH, while only blinded participants receive the placebo. The study uses a parallel group design to compare these interventions. During the study, participants symptoms are closely monitored, focusing on the time to clear symptom relief within 4 hours after injection. Researchers assess symptom severity changes and response rates to the treatment. Participants must comply with all study procedures and are evaluated through clinical assessments and safety monitoring throughout the trial, which lasts until the study completion in June 2027.