At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia
In Brief
A Phase 2 clinical trial evaluating Recombinant human plasma gelsolin (Rhu-pGSN) and Placebo for Sars-CoV2. Completed, enrolled 64 participants across 3 sites in 2 countries.
Detailed 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
Study Details
Timeline
Interventions
Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.