A Phase III, Multicentre, Randomised, Double-blind, Paral... | EligiMed

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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05624450RENIS: IS003939Tipo: INTERVENTIONALInicio: 13 de dic de 2022Fin estimado: 19 de jun de 2026

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Tozorakimab

Single IV dose of tozorakimab on Day 1.

drug

Placebo

Single IV dose of matching placebo on Day 1.

Ubicaciones

Research Site

Buenos Aires, Argentina

COMPLETED

Research Site

Buenos Aires, Argentina

COMPLETED

Research Site

Buenos Aires, Argentina

RECRUITING

Research Site

CABA, Argentina

COMPLETED

Research Site

CABA, Argentina

WITHDRAWN

Research Site

La Plata, Argentina

RECRUITING

Research Site

Mar del Plata, Argentina

COMPLETED

Research Site

Munro, Argentina

RECRUITING

Research Site

Rosario, Argentina

COMPLETED

Patrocinadores

PrincipalAstraZeneca

Contactos

AstraZeneca Clinical Study Information Center

CONTACT

information.center@astrazeneca.com 1-877-240-9479

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.