drugset / Trial / NCT04324021

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

NCT04324021

Phase 2/3 Terminated 16 enrolled Swedish Orphan Biovitrum
RandomizedParallel-groupOpen-labelTreatment

Summary

Hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system in the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered to represent one of the most important negative prognostic factors in patients infected with sSARS-CoV-2. The objective of this study is to investigate new treatment options to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.

Timeline

Start
2020-04-02
Primary completion
2020-11-13
Completion
2020-11-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anakinra Protein / enzyme biologic 100 mg Intravenous
Comparator Emapalumab Monoclonal antibody 3 mg/kg Intravenous

Indications