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Monoclonal Antibodies

EB05 for Hospitalized COVID-19 Patients

Phase 2 & 3
Recruiting
Research Sponsored by Edesa Biotech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized for COVID-19 related respiratory disease
Laboratory-confirmed diagnosis of COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 and 60 days
Awards & highlights

Study Summary

This trial is testing a potential new treatment, EB05, for people who have been hospitalized with COVID-19. The treatment is designed to target the initial step in the signalling pathways of these DAMPs in innate immunity.

Who is the study for?
Adults hospitalized with severe COVID-19 and respiratory issues, confirmed by lab tests. They must be at specific severity levels on a COVID-19 scale, not pregnant or breastfeeding, willing to use contraception if applicable, and able to give consent. Excluded are those improving significantly before treatment, likely to die within 72 hours regardless of treatment, in other drug trials for immunomodulators or immunosuppressants (with some exceptions), hypersensitive to EB05 or its components.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a potential treatment called EB05 combined with standard care versus a placebo plus standard care. The goal is to see if EB05 can help control the immune system's overreaction in severe COVID-19 cases that lead to ARDS by blocking certain inflammatory pathways.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, generally treatments like EB05 could cause reactions related to the immune system such as fever or fatigue; infusion-related reactions; allergic responses; or possibly impact organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am hospitalized due to COVID-19 related breathing issues.
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I have a lab-confirmed COVID-19 diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 and 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mortality rate at Day 28 from IP administration.
Secondary outcome measures
Mortality rate at Day 60
Proportion of patients with clinical improvement at Day 28
Proportion of patients with clinical improvement at Day 60
Other outcome measures
Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stage 2Experimental Treatment2 Interventions
Stage 2 (Phase III Study) For a 1:1 ratio of patients treated with EB05 vs. Placebo, a cumulative one-sided alpha of 2.5% and 90% power, to detect an Odds Ratio of 2.00, a total of 586 evaluable patients will be required for Stage 2 (Phase III study). 293 of these will be treated with EB05 + SOC and 293 treated with Placebo + SOC. Allowing for 10% attrition, a total of 644 patients will be enrolled in this Stage.
Group II: Stage 1Experimental Treatment2 Interventions
Stage 1 (Phase II Study) For 80% power (β = 0.20), at a significance level of 5% (α =0.05) and a 1:1 randomization ratio, a total of 316 (EB05: 158, SOC: 158) evaluable patients will be required. Allowing for 20% attrition a total of 396 patients will be recruited.

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Who is running the clinical trial?

Edesa Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
126 Total Patients Enrolled
JSS Medical Research Inc.Industry Sponsor
18 Previous Clinical Trials
4,851 Total Patients Enrolled
2 Trials studying COVID-19
360 Patients Enrolled for COVID-19

Media Library

EB05 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04401475 — Phase 2 & 3
COVID-19 Research Study Groups: Stage 1, Stage 2
COVID-19 Clinical Trial 2023: EB05 Highlights & Side Effects. Trial Name: NCT04401475 — Phase 2 & 3
EB05 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401475 — Phase 2 & 3
~67 spots leftby Dec 2024
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