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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 limitationMeasure: Proportion of subjects alive and free of respiratory failure Time: 29 Days
Description: Proportion of subjects achieving a ≥ 2 category improvement on 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29Measure: Secondary clinical improvement outcomes Time: 29 Days
Description: National early warning score (NEWS) of ≤2 maintained for 24 hoursMeasure: Time to clinical improvement (TTCI) Time: 29 Days
Description: 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 Days
Description: Serum concentrations of IL 6 and c-reactive protein (CRP) change from baseline to Day 15 or hospital discharge or deathMeasure: To evaluate changes in biomarkers following treatment with axatilimab Time: 15 Days
Description: Frequency and severity of AEs and SAEsMeasure: To evaluate the safety and tolerability of axatilimab in the same population Time: 29 Days
Description: Proportion of subjects who require initiation of mechanical ventilation after study entryMeasure: Ventilation outcomes Time: 29 Days
Description: Proportion of subjects who are SARS CoV-2 virus free by Day 15 or hospital discharge, whichever is soonerMeasure: To evaluate antiviral effect of axatilimab in hospitalized adults with recently diagnosed SARS CoV-2 infection Time: Day 15
Description: Serum concentration of axatilimab and presence of anti-drug antibodyMeasure: To characterize exposure to axatilimab Time: 29 Day
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports