Study Objectives:
Primary
- To assess the efficacy (survival without organ failure on Day 14) of three doses of
rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized
subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or
6 on the World Health Organization (WHO) 9-point severity scale
- To evaluate the safety and tolerability of three IV doses of rhu-pGSN administered to
hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity
score of 4, 5, or 6 on the WHO 9-point severity scale
Secondary
- To further assess the efficacy of IV administered rhu-pGSN
- To assess changes in WHO 9-point severity score for SOC with or without rhu-pGSN
- To evaluate the effect of administered rhu-pGSN on survival rates
- To assess the relationship of pGSN levels (and other biomarkers) at baseline with
clinical outcomes
- [OPTIONAL] To follow the pharmacokinetics (PK) of administered rhu-pGSN
Immunogenicity
• To investigate the development of antibodies against rhu-pGSN post-treatment