Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
NCT ID: NCT05624450
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2870 participants
INTERVENTIONAL
2022-12-13
2026-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tozorakimab
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
Tozorakimab
Single IV dose of tozorakimab on Day 1.
Placebo
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.
Placebo
Single IV dose of matching placebo on Day 1.
Interventions
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Tozorakimab
Single IV dose of tozorakimab on Day 1.
Placebo
Single IV dose of matching placebo on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
* Ongoing IMV/ECMO at randomisation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Chula Vista, California, United States
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Fresno, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Bradenton, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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South Pasadena, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Elmhurst, Illinois, United States
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Evanston, Illinois, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Saint Paul, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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New York, New York, United States
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New York, New York, United States
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Potsdam, New York, United States
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Chapel Hill, North Carolina, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Corvallis, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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La Plata, , Argentina
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Munro, , Argentina
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Rosario, , Argentina
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Adelaide, , Australia
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Bedford Park, , Australia
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New Lambton Heights, , Australia
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Port Macquarie, , Australia
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South Brisbane, , Australia
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Kortrijk, , Belgium
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Ottignies, , Belgium
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Roeselare, , Belgium
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Yvoir, , Belgium
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Belo Horizonte, , Brazil
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Campinas, , Brazil
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Caxias do Sul, , Brazil
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Curitiba, , Brazil
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Curitiba, , Brazil
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Indaiatuba, , Brazil
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Jaú, , Brazil
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Natal, , Brazil
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Passo Fundo, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Caetano do Sul, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Montana, , Bulgaria
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Rousse, , Bulgaria
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Chongqing, , China
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Guangzhou, , China
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Haikou, , China
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Hefei, , China
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Jining, , China
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Nanchang, , China
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Nantong, , China
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Qingdao, , China
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Shanghai, , China
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Wuhan, , China
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Yantai, , China
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Yinchuan, , China
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Yueyang, , China
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Zhengzhou, , China
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Bogota DC, , Colombia
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Floridablanca, , Colombia
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Medellín, , Colombia
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Soledad, , Colombia
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Villavicencio, , Colombia
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Benešov, , Czechia
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Brno, , Czechia
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Alexandria, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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New Cairo, , Egypt
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Amiens, , France
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Angers, , France
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Brest, , France
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Créteil, , France
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Dijon, , France
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Montpellier, , France
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Nantes, , France
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Augsburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Heraklion, , Greece
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Ioannina, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kistarcsa, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Ahmedabad, , India
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Ahmedabad, , India
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Belagavi, , India
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Chennai, , India
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Gurgaon, , India
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Gurugram, , India
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Hyderabad, , India
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Kanpur, , India
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Mumbai, , India
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New Delhi, , India
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Pune, , India
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Thāne, , India
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Vijayawada, , India
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Afula, , Israel
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Arezzo, , Italy
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Napoli, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Izumisano, , Japan
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Kamakura-shi, , Japan
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Kamogawa-shi, , Japan
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Kanazawa, , Japan
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Kanazawa, , Japan
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Kawasaki-shi, , Japan
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Koshigaya-shi, , Japan
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Kumagaya-shi, , Japan
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Kumamoto, , Japan
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Kusatsu-shi, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Mitaka-shi, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Yokohama, , Japan
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Terengganu, , Malaysia
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Kuantan, , Malaysia
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Kubang Kerian, , Malaysia
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Malacca, , Malaysia
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Petaling Jaya, , Malaysia
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Pulau Pinang, , Malaysia
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Sarawak Miri, , Malaysia
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Selangor Darul Ehsan, , Malaysia
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Shah Alam, , Malaysia
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Aguascalientes, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Tlalpan, , Mexico
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Tlalpan, , Mexico
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Xalapa, , Mexico
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Cusco, , Peru
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El Agustino, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Cebu, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Chrzanów, , Poland
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Lodz, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Łęczna, , Poland
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Bayamón, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Jeddah, , Saudi Arabia
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Bratislava, , Slovakia
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Johannesburg, Soweto, , South Africa
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Observatory, , South Africa
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Parktown, , South Africa
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Westdene, , South Africa
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Daegu, , South Korea
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Seoul, , South Korea
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Pamplona, , Spain
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Santander, , Spain
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Valencia, , Spain
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Helsingborg, , Sweden
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Huddinge, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Solna, , Sweden
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Stockholm, , Sweden
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İzmit, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Ortahisar, , Turkey (Türkiye)
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Bristol, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Prescot, , United Kingdom
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Haiphong, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2023-507031-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-003107-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9185C00001
Identifier Type: -
Identifier Source: org_study_id
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