Virginia Commonwealth University

To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Multicenter industry sponsored clinical trial exploring canakinumab, IL-1beta antibody, for the prevention of death and worsening respiratory failure in patients with COVID-19 pneumonia and hyper-inflammation.

The purpose of this study is to provide Remdesivir (RDV) to participants with severe COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to the normalization of temperature and oxygen saturation through Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV.

The purpose of this study is to provide Remdesivir (RDV) to participants with COVID-19. The primary objective is to evaluate the efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV compared to SOC.

CM4620-IE, a calcium release-activated calcium (CRAC) channel inhibitor, potently blocks the production and release of pro-inflammatory cytokines from immune cells, including those elevated by SARS-CoV-2 infection (e.g., IL-6, IL-17 and TNF-α) and may interrupt the cascade of events leading to acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 pneumonia. It may further directly protect the lung through a local effect on CRAC channels and modulation of NFAT-induced activation of the lung endothelium. Recently published literature showed that a CRAC channel inhibitor similar to CM4620 was beneficial in animal models of lung injury by both a direct effect on pulmonary endothelial cells, as well as a systemic effect on CRAC channels of immune cells. Lending further support are in vivo efficacy data on lung IL-6, TNFα, and MPO mRNA production in animals with experimental acute pancreatitis, a known cause of ALI/ARDS treated with CM4620-IE and data from a 2a study of CM4620-IE in patients with acute pancreatitis and accompanying SIRS with hypoxemia at presentation that showed both a reduction in significantly elevated IL-6 levels and improved oxygenation in patients treated with CM4620-IE.

Primary Objectives: Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19. Phase 3: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19.

Phase II clinical trial of GM-CSF-receptor antibody or placebo in patients with COVID-19 pneumonia and hyper-inflammation