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Can blocking a key inflammation switch save COVID-19 patients on ventilators?

NCT ID NCT04401475

Disease control Sponsor: Edesa Biotech Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 30, 2026 · Last updated Oct 01, 2026 · Updated 1 time

Summary

Researchers test whether an experimental antibody called EB05 can reduce deaths in adults hospitalized with severe COVID-19 who need mechanical ventilation. EB05 targets a protein on immune cells that drives runaway inflammation, a major cause of acute respiratory distress syndrome (ARDS) in these patients. Participants receive either EB05 or a placebo, both added to standard hospital care, and researchers track survival and clinical improvement over 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EB05, an experimental antibody that blocks the TLR4 inflammation pathway
What this could lead to
If EB05 works, it could become a treatment for the dangerous immune overreaction that causes lung failure in severe COVID-19 and possibly other infections.
What could go wrong
The trial is mid-stage and the results may not show a clear benefit. Blocking part of the immune response could also carry risks, and the drug may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

278 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women ≥18 years of age at the time of consent. 2. Laboratory-confirmed diagnosis of COVID-19. 3. Hospitalized for COVID-19 related respiratory disease. 4. Patient belongs to one of the following two categories in the nine-point COVID-19 severity scale: 1. Hospitalized, requiring intubation and mechanical ventilation - Level 6 of the nine-point COVID-19 severity scale. 2. Hospitalized and intubated with additional organ support - pressors, RRT, ECMO - Level 7 of the nine-point COVID-19 severity scale. 5. 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. 6. 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. Exclusion Criteria: 1. The subject is a female who is breastfeeding or pregnant. 2. Known hypersensitivity to EB05 or its excipients. 3. 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. 4. Experiencing cardiac arrest while hospitalized with COVID-19. 5. 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. 6. 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: 1. Treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of SOC for COVID-19 2. Transplant patients 7. Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgment of the clinician. 8. Patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product. 9. Patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product. 10. Patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARDS COVID-19

Contacts and locations

Locations

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • CISS Monteregie-Centre

    Greenfield Park, Quebec, J4V 2H2, Canada

  • Hôpital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Hôpital Régional de Rimouski

    Rimouski, Quebec, G5L 5T1, Canada

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9, Canada

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7P3, Canada

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9, Canada

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • St. Jude Medical Center/ Providence

    Fullerton, California, 92835, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • UCSF Fresno

    Fresno, California, 93701, United States

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Miami Hospital

    Coral Gables, Florida, 33146, United States

  • Vancouver Coastal Health

    Vancouver, British Columbia, V5K 1Z9, Canada

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Wayne State University

    Detroit, Michigan, 48202, United States

  • West Virginia University Medicine Heart & Vascular Institute

    Morgantown, West Virginia, 26506-6224, United States

  • William Osler Health System

    Brampton, Ontario, L6R 3J7, Canada

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