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Garadacimab, Factor XIIa Antagonist Monoclonal AntibodyWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug2556 Transplant patient Wiki 1.00
drug1822 Placebo Wiki 0.06

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D018352 Coronavirus Infections NIH 0.04

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There is one clinical trial.

Clinical Trials


1 A Phase 2, Multicenter, Double Blind, Randomized, Placebo-Controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID 19)

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
MeSH:Coronavirus Infections

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


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