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TERMINATED
NCT04401475
PHASE2/PHASE3

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.

View on ClinicalTrials.gov

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

Conditions

Interventions

BIOLOGICAL

SOC plus 15mg/kg EB05 IV

Standard of care plus single IV infusion of 15mg/kg of EB05.

OTHER

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