SOBI-COVID

A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.

Objective

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.

Study Arms

  • Active Comparator: Emapalumab
  • Active Comparator: Anakinra
  • No Intervention: Standard of care

Eligibility

  • Documented presence of SARS-CoV-2 infection as per hospital routine.    
  • Age > 30 to < 80 years at the time of screening.
  • Presence of respiratory distress, defined as:
    • PaO2/FiO2 < 300 mm Hg and >200 mm Hg or
    • Respiratory Rate (RR) ≥30 breaths/min or
    • SpO2 < 93 percent in air at rest. Note: Patients given continuous positive airway pressure (CPAP) ventilator support are eligible for inclusion.
  • Presence of hyperinflammation defined as:
    • Lymphocyte counts < 1000 cells/µL, and b. Two of the following three criteria: i. Ferritin > 500ng/mL ii. LDH > 300 U/L iii. D-Dimers > 1000 ng/mL