Visits and data collection
Data were collected via medical records and patient interviews entered into RedCap. Baseline measurements were defined as the clinical status assessment recorded on or before treatment initiation (randomization, study days 1 - D1). Daily visits until discharge were recorded for clinical assessments. The primary endpoint was assessed at the study visit on day 28 (D28). The participants had a follow-up visit 45 days after randomization (D45, telephone call). Plasma samples were collected on D1 and D28 to assess changes in the cytokine profile measured using a bead-based multiplex immunoassay for the simultaneous and quantitative detection of IFN-γ, IL-1β, IL-4, IL-6, IL-10, IL-18, and monocyte chemotactic protein (MCP1). 