Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19 — STRIKESARS  

COVID-19 Drug Treatment Clinical Trial

Official title: Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19

Status Recruiting

Clinical Trial Summary

Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).

Clinical Trial Description

Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).

The primary objective of the trial is to evaluate the impact of sarilumab on the progression of COVID 19-associated respiratory failure as measured by the change in a severity rating on a 7-point severity index. Secondary objectives include the evaluation of safety of the drug and the assessment of the impact of Sarilumab on markers of systemic inflammation and the coagulation cascade, on mortality, and on oxygenation.

The trial has two phases. Firstly, patients with pneumonia in the setting of COVID-19 who meet inclusion criteria and have no exclusion criteria will be treated with 2 doses of 200 mg IV of Sarilumab in 24 hours. After internal review, if no AE are detected and if there is no significant improvement, the next 55 patients will be treated with two doses of 400 mg IV in 24 hours. ;

Related Conditions & MeSH terms

• COVID-19 Drug Treatment
• Infection

• NCT number: NCT04661527
• Study type: Interventional
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Javier J Zulueta, MD
• Phone: +34948255400
• Email: jzulueta@unav.es
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2020
• Completion date: December 30, 2020