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drug2656 | Virtual Reality Pain Neuroscience Education Wiki | 1.00 |
drug1822 | Placebo Wiki | 0.06 |
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There is one clinical trial.
This is a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care, compared with placebo plus standard of care, in patients with respiratory signs and symptoms secondary to novel coronavirus disease (COVID-19).
Description: Respiratory failure as defined by need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation >6L oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation
Measure: Proportion of subjects alive and free of respiratory failure Time: 29 DaysDescription: Proportion of subjects achieving a ≥ 2 category improvement on 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29
Measure: Secondary clinical improvement outcomes Time: 29 DaysDescription: National early warning score (NEWS) of ≤2 maintained for 24 hours
Measure: Time to clinical improvement (TTCI) Time: 29 DaysDescription: Change from baseline to Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)
Measure: To evaluate improvement in oxygenation in hospitalized adults with respiratory signs and symptoms secondary to COVID 19 treated with axatilimab Time: 29 DaysDescription: Serum concentrations of IL 6 and c-reactive protein (CRP) change from baseline to Day 15 or hospital discharge or death
Measure: To evaluate changes in biomarkers following treatment with axatilimab Time: 15 DaysDescription: Frequency and severity of AEs and SAEs
Measure: To evaluate the safety and tolerability of axatilimab in the same population Time: 29 DaysDescription: Proportion of subjects who require initiation of mechanical ventilation after study entry
Measure: Ventilation outcomes Time: 29 DaysDescription: Proportion of subjects who are SARS CoV-2 virus free by Day 15 or hospital discharge, whichever is sooner
Measure: To evaluate antiviral effect of axatilimab in hospitalized adults with recently diagnosed SARS CoV-2 infection Time: Day 15Description: Serum concentration of axatilimab and presence of anti-drug antibody
Measure: To characterize exposure to axatilimab Time: 29 Day