Covid 19 Research using Clinical Trials (Home Page)
Garadacimab, Factor XIIa Antagonist Monoclonal AntibodyWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
Correlated MeSH Terms (1)
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D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
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There is one clinical trial.
Clinical Trials
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled,
parallel group study to assess the safety and efficacy of CSL312 administered intravenously,
in combination with standard of care (SOC) treatment, in patients with Coronavirus disease
2019 (COVID 19)
NCT04409509 Coronavirus Disease 2019 (COVID‑19) Biological: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody Drug: Placebo
Primary Outcomes
Measure: The incidence of tracheal intubation or death prior to tracheal intubation Time: From randomization to Day 28
Secondary Outcomes
Measure: Proportion of subjects with death from all causes Time: From randomization to Day 28
Measure: Proportion of subjects intubated Time: From randomization to Day 28
Measure: Number and proportion of subjects with ≥ 2‑point improvement on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal scale Time: From randomization to Day 28
Measure: Number and proportion of subjects within each of the categories of the NIAID Time: From randomization to Day 28
Measure: Proportion of subjects requiring continuous positive airway pressure (CPAP) Time: From randomization to Day 28
Measure: Proportion of subjects requiring bilevel positive airway pressure (BiPAP) Time: From randomization to Day 28
Measure: Proportion of subjects requiring high‑flow nasal cannula (HFNC) Time: From randomization to Day 28
Measure: Proportion of subjects requiring extracorporeal membrane oxygenation (ECMO) Time: From randomization to Day 28
Measure: Maximum change from baseline in Sequential Organ Failure Assessment (SOFA) score Time: From randomization to Day 28
Measure: Change from Baseline in SOFA score and in the individual components of SOFA score Time: From randomization to Day 28
Measure: Length of hospital stay Time: From randomization to Day 28
Measure: Number and proportion of subjects experiencing Adverse Events (AEs) Time: Up to 28 days after CSL312 or placebo administration
Measure: Number and proportion of subjects experiencing serious adverse events (SAEs) Time: Up to 28 days after CSL312 or placebo administration
Measure: Number and proportion of subjects with adverse events of special interest (AESIs) Time: Up to 28 days after CSL312 or placebo administration
Measure: Number and proportion of subjects with CSL312 induced anti‑CSL312 antibodies Time: Up to 28 days after CSL312 or placebo administration
Measure: Maximum plasma concentration (Cmax) of CSL312 Time: Up to 28 days after CSL312 administration
Measure: Time to maximum plasma concentration (Tmax) of CSL312 Time: Up to 28 days after CSL312 administration
Measure: Area under the plasma concentration‑time curve from time zero to the time of the last measurable concentration (AUC0‑last) of CSL312 Time: Up to 28 days after CSL312 administration
Measure: Terminal half-life (T1/2) of CSL312 Time: Up to 28 days after CSL312 administration
No related HPO nodes (Using clinical trials)