drugset / Trial / NCT04581954

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

NCT04581954

RandomizedParallel-groupSingle-blindTreatment

Summary

The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.

Timeline

Start
2020-10-02
Primary completion
2022-11-30
Completion
2023-09-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fostamatinib Small molecule 100 mg Oral
Comparator Ruxolitinib Small molecule 5 mg Oral

Indications