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Monoclonal Antibodies

EB05 for Hospitalized COVID-19 Patients

Phase 2 & 3

Waitlist Available

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

Must not have

The subject is a female who is breastfeeding or pregnant

Patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 and 60 days

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I have been on a ventilator for more than 72 hours before getting the study drug.

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I had a cardiac arrest while in the hospital for COVID-19.

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I was put on a breathing machine and then taken off it during this hospital stay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 and 60 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mortality rate at Day 28 from IP administration.

Secondary study objectives

Mortality rate at Day 60

Proportion of patients with clinical improvement at Day 28

Proportion of patients with clinical improvement at Day 60

Other study objectives

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.

0 / 6Eligibility criteria met