Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for Hospitalised Patients with Mild or Moderate COVID-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomised Controlled Trial

Abstract

The primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Secondary objectives, at 14 and 28 days, are to: · Determine the efficacy of RUX or FOS to reduce mortality · Determine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMO· Determine the efficacy of RUX or FOS to reduce the need for non-invasive ventilation · Determine the efficacy of RUX or FOS to reduce the proportion of participants suffering significant oxygen desaturationDetermine the efficacy of RUX or FOS to reduce the need for renal replacement therapy · Determine the efficacy of RUX and FOS to reduce the incidence of venous thromboembolism · Determine the efficacy of RUX and FOS to reduce the severity of COVID-19 pneumonia [graded by a 9-point modified WHO Ordinal Scale*· Determine the efficacy of RUX or FOS to reduce systemic inflammation· Determine the efficacy of RUX or FOS to the incidence of renal impairment · Determine the efficacy of RUX or FOS to reduce duration of hospital stay · Evaluate the safety of RUX and FOS for treatment of COVID-19 pneumonia.Trial designA multi-arm, multi-stage (3-arm parallel-group, 2-stage) randomised controlled trial that allocates participants 1:1:1 and tests for superiority in experimental arms versus standard of care.