COVID-19 Infection Clinical Trial
Official title:
A Phase 2 Trial to Evaluate the Safety and Tolerability of Clazakizumab® [Anti-Interleukin (IL)-6 Monoclonal] Compared to Placebo for the Treatment of COVID-19 Infection
The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the
safety and efficacy of clazakizumab vs placebo for the prevention of acute respiratory
distress syndrome (ARDS) in patients with COVID-19 and pulmonary manifestations. The study
will compare clazakizumab to placebo in a randomized, double-blind fashion followed by an
open-label dose of clazakizumab if there is no improvement or a worsening of condition occurs
after 24-hours or anytime during the first 14 days after the first dose of clazakizumab or
placebo. We hypothesize that clazakizumab will be safely tolerated and will reduce the risk
of progression of COVID-19 to acute respiratory distress syndrome.
Primary Objective:
• To evaluate the safety and tolerability of clazakizumab vs placebo for the treatment of
patients with COVID-19 disease and signs of pulmonary involvement
Sixty adult patients with COVID-19 and signs of pulmonary involvement at Houston Methodist
who are not in need of ventilator support at the time of enrollment.
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