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
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
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.
Inclusion Criteria:
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:
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CABA, C1221ADC, Argentina
CABA, C1425EOE, Argentina
Bogota DC, 111121, Colombia
Copenhagen Ø, 2100, Denmark
Exohi Thessaloniki, 57010, Greece
Ginowan-shi, 901-2725, Japan
Hanyu-shi, 348-8505, Japan
Hitachi-shi, 317-0077, Japan
Isehara-shi, 259-1193, Japan
Izumo-shi, 693-8501, Japan
Kamakura-shi, 247-8533, Japan
Kamogawa-shi, 296-8602, Japan
Kasuga-shi, 816-0864, Japan
Kawasaki-shi, 216-8511, Japan
Koshigaya-shi, 343-8555, Japan
Kumagaya-shi, 360-0197, Japan
Kusatsu-shi, 525-8585, Japan
Meguro-ku, 152-8902, Japan
Mitaka-shi, 181-8611, Japan
Nerima-ku, 179-0072, Japan
Okazaki-shi, 444-0827, Japan
Omuta-shi, 837-0911, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 162-8655, Japan
Suita-shi, 565-0871, Japan
Tachikawa-shi, 190-8531, Japan
Urasoe-shi, 901-2132, Japan
Ureshino-shi, 843-0393, Japan
Sarawak Miri, 98000, Malaysia
Selangor Darul Ehsan, 42300, Malaysia
Johannesburg, Soweto, 2013, South Africa
Banphaeo, 74120, Thailand
Phutthamonthon, 73170, Thailand
Ubonratchathani, 34000, Thailand
Hampshire, SO16 6YD, United Kingdom
Tyne and Wear, NE29 8NH, United Kingdom
Hochiminh City, 700000, Vietnam