Phase 2 Study Comparing Clazakizumab to Placebo for Treating COVID-19 Lung Infection and Preventing Severe Breathing Problems

What this Trial Is About

Researchers are evaluating clazakizumab, an antibody that blocks certain inflammatory processes, compared to a placebo to treat COVID-19 infection. This study focuses on patients with COVID-19 who show signs of lung involvement but are not yet on ventilators. The goal is to see if clazakizumab can safely reduce the risk of the disease progressing to acute respiratory distress syndrome ARDS. Participants are randomly assigned to receive either clazakizumab or placebo through an intravenous infusion over 30 minutes. If a participants condition does not improve or worsens within 24 hours or up to 14 days after the first dose, they may receive an open-label dose of clazakizumab. This trial is double-blind during the initial treatment period and then open-label as needed. During the study, participants will be monitored closely for safety and effectiveness through assessments such as clinical status scales, lung imaging, survival, and need for mechanical ventilation or intensive care. The main outcome is measured 24 hours after infusion, with further follow-up up to 60 days to track hospital stay, ICU time, and lung condition changes. The total participation time varies depending on individual progress and follow-up requirements.

Clazakizumab vs. Placebo - COVID-19 Infection