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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Infusion
Infusion
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGPrimary Endpoint
Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo
Time frame: 24 hours
Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)
Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo
Time frame: 14 days
Infusion-related reactions during 24 hours from the time of infusion
Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo
Time frame: 24 hours
Patient survival at 28 days
Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo
Time frame: 28 days
Patient survival at 60 days
Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo
Time frame: 60 days
Requirement for open-label clazakizumab
Proportion of participants who require an open-label dose of clazakizumab
Time frame: 14 days
Time in the intensive care unit (ICU)
Number of days in the ICU following the first dose of clazakizumab or placebo
Time frame: 60 days
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Time in the hospital
Number of days in the hospital following the first dose of clazakizumab or placebo
Time frame: 60 days
Time to mechanical ventilation
Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation
Time frame: 60 days
Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14
Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Time frame: 14 days
Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28
Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Time frame: 28 days
Change in Radiologic Assessment of Lung Edema (RALE) at day 14
Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo
Time frame: 14 days
Change in Radiologic Assessment of Lung Edema (RALE) at day 28
Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo
Time frame: 28 days