Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Su… (NCT05624450) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
United States, Argentina, Australia2,870 participantsStarted 2022-12-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)