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
- for people ages 18 years and up (full criteria)
- at UCSF
- study startedestimated completion
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.
COVID-19 ARDS TLR4 SOC plus 15mg/kg EB05 IV
You can join if…
Open to people ages 18 years and up
- 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 four categories in the nine-point COVID-19 severity scale:
- Hospitalized, not requiring supplemental oxygen - Level 3 of the nine-point COVID-19 severity scale.
- Hospitalized, requiring supplemental oxygen - Level 4 of the nine-point COVID-19 severity scale.
- Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both - Level 5 of the nine-point COVID-19 severity scale.
- Hospitalized, requiring intubation and mechanical ventilation- Level 6 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 form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives.
You CAN'T join if...
- The subject is a female who is breastfeeding or pregnant.
- Known hypersensitivity to EB05 or its excipients.
- Mechanical ventilation (including venovenous ECMO) for ≥5 days (120 hours), or any duration of venoarterial ECMO.
- In the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.
- Active participation in other drug clinical trials.
- Treatment with immunomodulator or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (Note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of SOC, is permitted).
- Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgment of the clinician.
- Possibility of the subject being transferred to a non-study hospital within 72h.
- UCSF Fresno
accepting new patients
Fresno California 93701 United States
- St. Joseph Hospital, Orange - Providence
accepting new patients
Orange California 92868 United States
- accepting new patients
- Start Date
- Completion Date
- Edesa Biotech Inc.
- Phase 2
- Study Type
- Last Updated