Clinical trial NCT05624450: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Viral Lung Infection and Acute Respiratory Failure
Keywords: Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Viral lung infection
Tozorakimab
Supplemental Oxygen
IL-33
COVID-19
SARS-CoV-2
Coronavirus Infections
Virus Diseases
SARS Coronavirus
MEDI3506
Respiratory Tract Infections
Infections
Lung Diseases
Influenza
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 2870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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:

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.

Primary outcomes:
measure: Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
timeFrame: by Day 28
Secondary outcomes:
measure: Proportion of participants who die
timeFrame: by Day 60
measure: Number of days alive and outside of Intensive Care Unit (ICU)
timeFrame: over 28 day period
measure: Number of days alive and free of supplemental oxygen
timeFrame: over 28 day period
measure: Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
timeFrame: over 28 day and 60 day period
measure: Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
timeFrame: by Day 60
measure: Time to death (all cause)
timeFrame: over 28 day and 60 day period
measure: Proportion of participants who die
timeFrame: by Day 28
measure: Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
timeFrame: over 28 day and 60 day period
measure: Number of days alive and ventilator free
timeFrame: over 28 day and 60 day period
measure: Proportion of participants with Intensive Care Unit (ICU) admission or death
timeFrame: by Day 28
measure: Proportion of participants with Intensive Care Unit (ICU) admission or death
timeFrame: by Day 60
measure: Proportion of participants alive and discharged
timeFrame: by Day 28
measure: Proportion of participants alive and discharged
timeFrame: by Day 60
measure: Time to discharge
timeFrame: over 28 day and 60 day period
measure: Time to being off supplemental oxygen
timeFrame: over 28 day and 60 day period
measure: World Health Organization (WHO) 10-category ordinal Clinical Progression Scale
timeFrame: by Day 60
measure: Presence of anti-drug antibodies
timeFrame: over 60 day period
measure: Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint
timeFrame: Day 1
Other outcomes:
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city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Cebu
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Chrzanów
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łańcut
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łęczna
country: Poland
facility: Research Site
city: Bayamon
country: Puerto Rico
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Johannesburg, Soweto
country: South Africa
facility: Research Site
city: Observatory
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Westdene
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Banphaeo
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon-Kaen
country: Thailand
facility: Research Site
city: Phutthamonthon
country: Thailand
facility: Research Site
city: Ubonratchathani
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Istambul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: İzmit
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Ortahisar
country: Turkey
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hampshire
country: United Kingdom
facility: Research Site
city: Huddersfield
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Prescot
country: United Kingdom
facility: Research Site
city: Tyne And Wear
country: United Kingdom
facility: Research Site
city: Wythenshawe
country: United Kingdom
facility: Research Site
city: Hai Phong
country: Vietnam
facility: Research Site
city: Hai Phong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh city
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
References: