Testing Tozorakimab against a placebo for viral lung infection and acute respiratory failure
Official title: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Interventions
Tozorakimab
Single IV dose of tozorakimab on Day 1.
Placebo
Single IV dose of matching placebo on Day 1.
Canadian Sites (15)
Research Site
Calgary, Alberta, Canada
Research Site
New Westminster, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Lévis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adult participants ≥ 18 years old at the time of signing the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Patients hospitalised with viral lung infection.
- +Hypoxaemia requiring treatment with supplemental O2.
- +Hypoxaemia is defined as:
- +SpO2 ≤ 90% OR
- +SpO2 ≤ 92% AND one or both of the following:
- +Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → judgement.
- +Use of accessory muscles of respiration or RR (respiratory rate) \> 22.
- +\- Patient remains hypoxaemic at randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → requiring treatment with supplemental oxygen.
Exclusion
- −Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, bacterial infection defines the severity of the participant's condition.
- −Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
- −Ongoing IMV/ECMO at randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Tozorakimab, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,527 people.
The study is currently expected to finish around November 2027.
The main measurement is taken over: by Day 28.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) — measured over by Day 28.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05624450 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TozorakimabDrug
Single IV dose of tozorakimab on Day 1.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Single IV dose of matching placebo on Day 1.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: by Day 28.
The study as a whole is currently expected to finish around 2027-11-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 3,527 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 17 locations, including: Calgary, Alberta, Canada; New Westminster, British Columbia, Canada; Winnipeg, Manitoba, Canada; Brampton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada, and 11 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
Other Sites (9)
Research Site
Detroit, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Royal Oak, Michigan, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Brooklyn, New York, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Potsdam, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.