Rhu-pGSN for Severe Covid-19 Pneumonia

Summary

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

Timeline

Start

2020-07-30

Primary completion

2021-05-25

Completion

2022-01-28

Drugs

Indications