Tozorakimab for Viral Lung Infection Requiring Oxygen
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Recruiting
Phase 3Interventional Study
Viral Lung Infection and Acute Respiratory Failure
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
3,527 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults who are hospitalized with a viral lung infection and need extra oxygen. Participants will receive treatment with tozorakimab along with their usual care to see if it helps prevent worsening conditions.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I am hospitalized with a viral lung infection.
I need supplemental oxygen due to low blood oxygen levels.
You may not be able to join if
I have a fungal or parasitic lung infection.
I have a lung abscess or evidence of septic shock.
My low blood oxygen is due to a non-infectious cause.
I am currently on a ventilator or ECMO.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Adult participants ≥ 18 years old at the time of signing the informed consent form.
* 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:…
Inclusion Criteria:
* Adult participants ≥ 18 years old at the time of signing the informed consent form.
* 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 investigator judgement.
Use of accessory muscles of respiration or RR (respiratory rate) \> 22.
\- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.
Exclusion Criteria:
* 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 investigator, 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 randomisation.
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