Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19
Sponsor: Edesa Biotech Inc.
Summary
COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis. This proinflammatory cascade is activated when viral-mediated cell damage occurs in the lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9 (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. These damage-associated molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and result in additional release of pro-inflammatory molecules. Several recent studies have shown that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both neutrophil count and disease severity. Taken together the DAMP-TLR4 interaction forms a central axis in the innate immune system and is a key driver of the pathological inflammation observed in COVID-19. We hypothesis that targeting the initial step in the signalling pathways of these DAMPs in innate immunity offers the best hope for controlling the exaggerated host response to SARS-CoV-2 infection. EB05 has demonstrated safety in two clinical studies (\>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
278
Start Date
2020-11-25
Completion Date
2024-07-22
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
SOC plus 15mg/kg EB05 IV
Standard of care plus single IV infusion of 15mg/kg of EB05.
SOC plus Placebo IV
Standard of care plus a single IV infusion of placebo.
Locations (20)
UCSF Fresno
Fresno, California, United States
St. Jude Medical Center/ Providence
Fullerton, California, United States
University of Miami Hospital
Coral Gables, Florida, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Providence Portland Medical Center
Portland, Oregon, United States
West Virginia University Medicine Heart & Vascular Institute
Morgantown, West Virginia, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
William Osler Health System
Brampton, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CISS Monteregie-Centre
Greenfield Park, Quebec, Canada
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hôpital Régional de Rimouski
Rimouski, Quebec, Canada