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

Paused · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19, ARDS

In brief

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 facts

Study ID: NCT04401475
Run by: Edesa Biotech Inc.
People needed: 644
Starts: 2020-11-25
Expected to finish: 2024-12-01
Last updated by the study team: 2024-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women ≥18 years of age at the time of consent.
Laboratory-confirmed diagnosis of COVID-19.
Hospitalized for COVID-19 related respiratory disease.
Patient belongs to one of the following two categories in the nine-point COVID-19 severity scale:
Hospitalized, requiring intubation and mechanical ventilation - Level 6 of the nine-point COVID-19 severity scale.
Hospitalized and intubated with additional organ support - pressors, RRT, ECMO - Level 7 of the nine-point COVID-19 severity scale.
For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during the study period.
Signed informed consent obtained by any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives.

You may not qualify if…

The subject is a female who is breastfeeding or pregnant.
Known hypersensitivity to EB05 or its excipients.
In the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment.
Experiencing cardiac arrest while hospitalized with COVID-19.
Active participation in other immunomodulator or immunosuppressant drug clinical trials.
a. Participation in COVID-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis.
Treatment with immunomodulator or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. Except for the following, which are permitted:
Treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of SOC for COVID-19
Transplant patients
Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgment of the clinician.
Patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product.
Patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product.
Patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

Where it is running

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

Full record on ClinicalTrials.gov

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