Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)
August 27, 2026 updated by: AstraZeneca
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
3527
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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-
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Buenos Aires, Argentina, C1180AAV
- Recruiting
- Research Site
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Buenos Aires, Argentina, C1046
- Completed
- Research Site
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Buenos Aires, Argentina, C1120AAF
- Completed
- Research Site
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CABA, Argentina, C1221ADC
- Completed
- Research Site
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CABA, Argentina, C1425EOE
- Withdrawn
- Research Site
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La Plata, Argentina, B1900AVG
- Recruiting
- Research Site
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Mar del Plata, Argentina, B7600GWV
- Completed
- Research Site
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Munro, Argentina, B1605FRE
- Recruiting
- Research Site
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Rosario, Argentina, S2000CVB
- Completed
- Research Site
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-
-
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Adelaide, Australia, 5000
- Recruiting
- Research Site
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Bedford Park, Australia, 5042
- Recruiting
- Research Site
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New Lambton Heights, Australia, 2305
- Completed
- Research Site
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Port Macquarie, Australia, 2444
- Recruiting
- Research Site
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South Brisbane, Australia, 4101
- Recruiting
- Research Site
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-
-
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Kortrijk, Belgium, 8500
- Recruiting
- Research Site
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Ottignies, Belgium, 1340
- Recruiting
- Research Site
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Roeselare, Belgium, 8800
- Recruiting
- Research Site
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Yvoir, Belgium, 5530
- Recruiting
- Research Site
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-
-
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Belo Horizonte, Brazil, 30150-221
- Withdrawn
- Research Site
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Campinas, Brazil, 13060-904
- Recruiting
- Research Site
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Caxias do Sul, Brazil, 95070-560
- Recruiting
- Research Site
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Curitiba, Brazil, 80215-901
- Suspended
- Research Site
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Curitiba, Brazil, 80730-150
- Suspended
- Research Site
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Indaiatuba, Brazil, 13331-501
- Suspended
- Research Site
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Jaú, Brazil, 17201-130
- Recruiting
- Research Site
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Natal, Brazil, 59025-050
- Recruiting
- Research Site
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Niterói, Brazil, 24020-096
- Withdrawn
- Research Site
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Passo Fundo, Brazil, 99010-260
- Recruiting
- Research Site
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Porto Alegre, Brazil, 90020-090
- Recruiting
- Research Site
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Porto Alegre, Brazil, 9061-000
- Recruiting
- Research Site
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Recife, Brazil, 50070-070
- Withdrawn
- Research Site
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Ribeirão Preto, Brazil, 14049-901
- Withdrawn
- Research Site
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Rio de Janeiro, Brazil, 21040-900
- Recruiting
- Research Site
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Salvador, Brazil, 40170-130
- Suspended
- Research Site
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São Caetano do Sul, Brazil, 09521-160
- Recruiting
- Research Site
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São José do Rio Preto, Brazil, 15090-000
- Recruiting
- Research Site
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São Paulo, Brazil, 04004-030
- Withdrawn
- Research Site
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São Paulo, Brazil, 09323-900
- Suspended
- Research Site
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Montana, Bulgaria, 3400
- Withdrawn
- Research Site
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Pernik, Bulgaria, 2300
- Suspended
- Research Site
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Pleven, Bulgaria, 5800
- Suspended
- Research Site
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Rousse, Bulgaria, 7002
- Suspended
- Research Site
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Sofia, Bulgaria, 1407
- Withdrawn
- Research Site
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Sofia, Bulgaria, 1431
- Withdrawn
- Research Site
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Sofia, Bulgaria, 1000
- Withdrawn
- Research Site
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Sofia, Bulgaria, 1154
- Withdrawn
- Research Site
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Sofia, Bulgaria, 1606
- Suspended
- Research Site
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Varna, Bulgaria, 9010
- Withdrawn
- Research Site
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-
-
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Alberta
-
Calgary, Alberta, Canada, T2N 1N4
- Recruiting
- Research Site
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-
British Columbia
-
New Westminster, British Columbia, Canada, V3L 3W7
- Withdrawn
- Research Site
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-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- Withdrawn
- Research Site
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Winnipeg, Manitoba, Canada, R3A 1R9
- Withdrawn
- Research Site
-
Winnipeg, Manitoba, Canada, R3J 3M7
- Withdrawn
- Research Site
-
-
Ontario
-
Brampton, Ontario, Canada, L6R 3J9
- Recruiting
- Research Site
-
Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- Research Site
-
Ottawa, Ontario, Canada, K1Y 4E9
- Recruiting
- Research Site
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Research Site
-
-
Quebec
-
Lévis, Quebec, Canada, G6V 3Z1
- Recruiting
- Research Site
-
Montreal, Quebec, Canada, H2X 3E4
- Recruiting
- Research Site
-
Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- Research Site
-
Montreal, Quebec, Canada, H2W 1S6
- Recruiting
- Research Site
-
Québec, Quebec, Canada, G1V 4G5
- Recruiting
- Research Site
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 0W8
- Recruiting
- Research Site
-
-
-
-
-
Anyang, China, 455099
- Recruiting
- Research Site
-
Beijing, China, 100029
- Recruiting
- Research Site
-
Beijing, China
- Recruiting
- Research Site
-
Beijing, China, 101199
- Recruiting
- Research Site
-
Beijing, China, 100015
- Recruiting
- Research Site
-
Changchun, China, 130041
- Recruiting
- Research Site
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Changsha, China, 410004
- Recruiting
- Research Site
-
Changsha, China, 410015
- Recruiting
- Research Site
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Chengdu, China, 610000
- Recruiting
- Research Site
-
Chengdu, China, 610072
- Recruiting
- Research Site
-
Chongqing, China, 400010
- Recruiting
- Research Site
-
Chongqing, China, 402160
- Not yet recruiting
- Research Site
-
Fuyang, China, 236012
- Recruiting
- Research Site
-
Guangzhou, China, 510180
- Recruiting
- Research Site
-
Guangzhou, China, 510515
- Withdrawn
- Research Site
-
Haikou, China, 570311
- Recruiting
- Research Site
-
Hangzhou, China, 310006
- Recruiting
- Research Site
-
Hangzhou, China, 310016
- Recruiting
- Research Site
-
Hefei, China, 230001
- Withdrawn
- Research Site
-
Jinhua, China, 321099
- Recruiting
- Research Site
-
Jining, China, 272006
- Recruiting
- Research Site
-
Nanchang, China, 330006
- Recruiting
- Research Site
-
Nanjing, China, 211100
- Recruiting
- Research Site
-
Nantong, China, 226001
- Recruiting
- Research Site
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Ningbo, China, 315010
- Recruiting
- Research Site
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Qingdao, China, 266011
- Recruiting
- Research Site
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Shanghai, China, 200025
- Recruiting
- Research Site
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Shanghai, China, 200032
- Recruiting
- Research Site
-
Shanghai, China, 201199
- Recruiting
- Research Site
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Shanghai, China, 200240
- Recruiting
- Research Site
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Shanghai, China, CN-200433
- Recruiting
- Research Site
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Shenzhen, China, 518020
- Recruiting
- Research Site
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Tianjin, China, 300050
- Recruiting
- Research Site
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Weifang, China, 261041
- Recruiting
- Research Site
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Wuhan, China, 430030
- Recruiting
- Research Site
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Wuhan, China, 430023
- Withdrawn
- Research Site
-
Xinxiang, China, 453100
- Recruiting
- Research Site
-
Yangzhou, China, 225001
- Recruiting
- Research Site
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Yantai, China, 264000
- Recruiting
- Research Site
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Yinchuan, China, 750004
- Recruiting
- Research Site
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Yueyang, China, 414000
- Recruiting
- Research Site
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Zhengzhou, China, 450000
- Recruiting
- Research Site
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-
-
-
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Bogota DC, Colombia, 111121
- Withdrawn
- Research Site
-
Floridablanca, Colombia, 681004
- Completed
- Research Site
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Medellín, Colombia, 050021
- Completed
- Research Site
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Soledad, Colombia, 083001
- Completed
- Research Site
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Villavicencio, Colombia, 500001
- Completed
- Research Site
-
-
-
-
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Benešov, Czechia, 256 01
- Completed
- Research Site
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Brno, Czechia, 625 00
- Completed
- Research Site
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Hradec Králové, Czechia, 500 05
- Withdrawn
- Research Site
-
Kolín, Czechia, 280 02
- Recruiting
- Research Site
-
Kyjov, Czechia, 697 01
- Completed
- Research Site
-
Mladá Boleslav, Czechia, 293 01
- Completed
- Research Site
-
Prague, Czechia, 100 34
- Withdrawn
- Research Site
-
Prague, Czechia, 150 30
- Withdrawn
- Research Site
-
Prague, Czechia, 18000
- Recruiting
- Research Site
-
-
-
-
-
Aalborg, Denmark, 9000
- Recruiting
- Research Site
-
Aarhus N, Denmark, 8200
- Recruiting
- Research Site
-
Copenhagen, Denmark, 2400
- Recruiting
- Research Site
-
Copenhagen Ø, Denmark, 2100
- Recruiting
- Research Site
-
Herning, Denmark, 7400
- Recruiting
- Research Site
-
Hillerød, Denmark, 3400
- Recruiting
- Research Site
-
Hvidovre, Denmark, 2650
- Recruiting
- Research Site
-
Kolding, Denmark, 6000
- Recruiting
- Research Site
-
Odense C, Denmark, 5000
- Recruiting
- Research Site
-
Vejle, Denmark, 7100
- Recruiting
- Research Site
-
-
-
-
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Alexandria, Egypt, 21131
- Withdrawn
- Research Site
-
Cairo, Egypt, 11561
- Withdrawn
- Research Site
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Cairo, Egypt, 11566
- Withdrawn
- Research Site
-
New Cairo, Egypt, 11566
- Withdrawn
- Research Site
-
-
-
-
-
Amiens, France, 80054
- Recruiting
- Research Site
-
Angers, France, 49033
- Recruiting
- Research Site
-
Brest, France, 29609
- Recruiting
- Research Site
-
Créteil, France, 94000
- Recruiting
- Research Site
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Dijon, France, 21000
- Recruiting
- Research Site
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La Tronche, France, 38700
- Recruiting
- Research Site
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Le Coudray, France, 28630
- Recruiting
- Research Site
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Montpellier, France, 34295
- Recruiting
- Research Site
-
Nantes, France, 44800
- Recruiting
- Research Site
-
Orléans, France, 45100
- Recruiting
- Research Site
-
Strasbourg, France, 67091
- Recruiting
- Research Site
-
Strasbourg, France, 67098
- Completed
- Research Site
-
Tours, France, 37000
- Recruiting
- Research Site
-
-
-
-
-
Augsburg, Germany, 86156
- Recruiting
- Research Site
-
Berlin, Germany, 12351
- Recruiting
- Research Site
-
Berlin, Germany, 10117
- Terminated
- Research Site
-
Cologne, Germany, 51109
- Recruiting
- Research Site
-
Hamburg, Germany, 20246
- Completed
- Research Site
-
Hanover, Germany, 30625
- Recruiting
- Research Site
-
Kiel, Germany, 24105
- Recruiting
- Research Site
-
Leverkusen, Germany, 51375
- Completed
- Research Site
-
Marburg, Germany, 35043
- Recruiting
- Research Site
-
Regensburg, Germany, 93053
- Withdrawn
- Research Site
-
Rosenheim, Germany, 83022
- Recruiting
- Research Site
-
Rostock, Germany, 18057
- Recruiting
- Research Site
-
-
-
-
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Athens, Greece, 12462
- Recruiting
- Research Site
-
Athens, Greece, 11527
- Withdrawn
- Research Site
-
Exohi Thessaloniki, Greece, 57010
- Recruiting
- Research Site
-
Heraklion, Greece, 71500
- Recruiting
- Research Site
-
Ioannina, Greece, 45500
- Recruiting
- Research Site
-
Thessaloniki, Greece, 57010
- Completed
- Research Site
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-
-
-
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Hong Kong, Hong Kong, 999077
- Withdrawn
- Research Site
-
Shatin, Hong Kong, 00000
- Withdrawn
- Research Site
-
-
-
-
-
Balassagyarmat, Hungary, 2660
- Completed
- Research Site
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Budapest, Hungary, 1082
- Recruiting
- Research Site
-
Budapest, Hungary, 1121
- Completed
- Research Site
-
Debrecen, Hungary, 4032
- Recruiting
- Research Site
-
Győr, Hungary, 9024
- Completed
- Research Site
-
Kaposvár, Hungary, 7400
- Not yet recruiting
- Research Site
-
Kistarcsa, Hungary, 2143
- Withdrawn
- Research Site
-
Nyíregyháza, Hungary, 4400
- Recruiting
- Research Site
-
Pécs, Hungary, 7624
- Recruiting
- Research Site
-
-
-
-
-
Ahmedabad, India, 380054
- Suspended
- Research Site
-
Ahmedabad, India, 382415
- Terminated
- Research Site
-
Belagavi, India, 590010
- Recruiting
- Research Site
-
Chennai, India, 600113
- Suspended
- Research Site
-
Dehradun, India, 248001
- Recruiting
- Research Site
-
Gurgaon, India, 122001
- Recruiting
- Research Site
-
Gurugram, India, 122001
- Withdrawn
- Research Site
-
Hyderabad, India, 500035
- Suspended
- Research Site
-
Hyderabad, India, 500068
- Recruiting
- Research Site
-
Kanpur, India, 208002
- Recruiting
- Research Site
-
Mumbai, India, 400008
- Withdrawn
- Research Site
-
New Delhi, India, 110029
- Recruiting
- Research Site
-
New Delhi, India, 110017
- Recruiting
- Research Site
-
New Delhi, India, 110060
- Withdrawn
- Research Site
-
Pune, India, 411043
- Terminated
- Research Site
-
Thane, India, 401107
- Suspended
- Research Site
-
Vijayawada, India, 520 008
- Recruiting
- Research Site
-
-
-
-
-
Afula, Israel, 18341
- Recruiting
- Research Site
-
Ashkelon, Israel, 7830604
- Recruiting
- Research Site
-
Beersheba, Israel, 8410101
- Withdrawn
- Research Site
-
Haifa, Israel, 34362
- Recruiting
- Research Site
-
Holon, Israel, 58100
- Recruiting
- Research Site
-
Jerusalem, Israel, 91120
- Recruiting
- Research Site
-
Petah Tikva, Israel, 4941492
- Terminated
- Research Site
-
Ramat Gan, Israel, 52621
- Recruiting
- Research Site
-
Rehovot, Israel, 76100
- Recruiting
- Research Site
-
-
-
-
-
Arezzo, Italy, 52100
- Completed
- Research Site
-
Brescia, Italy, 25123
- Completed
- Research Site
-
Naples, Italy, 80131
- Recruiting
- Research Site
-
Roma, Italy, 00128
- Recruiting
- Research Site
-
Roma, Italy, 00149
- Completed
- Research Site
-
Rozzano, Italy, 20089
- Recruiting
- Research Site
-
Torino, Italy, 10149
- Completed
- Research Site
-
-
-
-
-
Chiba, Japan, 260-0852
- Recruiting
- Research Site
-
Fukuoka, Japan, 814-0180
- Recruiting
- Research Site
-
Gifu, Japan, 502-8558
- Recruiting
- Research Site
-
Ginowan-shi, Japan, 901-2725
- Recruiting
- Research Site
-
Hanyu-shi, Japan, 348-8505
- Recruiting
- Research Site
-
Hiroshima, Japan, 734-8530
- Recruiting
- Research Site
-
Hiroshima, Japan, 734-8551
- Withdrawn
- Research Site
-
Hitachi-shi, Japan, 317-0077
- Recruiting
- Research Site
-
Isehara-shi, Japan, 259-1193
- Recruiting
- Research Site
-
Izumisano, Japan, 598-8577
- Withdrawn
- Research Site
-
Izumo-shi, Japan, 693-8501
- Recruiting
- Research Site
-
Kamakura-shi, Japan, 247-8533
- Recruiting
- Research Site
-
Kamogawa-shi, Japan, 296-8602
- Withdrawn
- Research Site
-
Kanazawa, Japan, 920-8650
- Recruiting
- Research Site
-
Kanazawa, Japan, 920-8641
- Withdrawn
- Research Site
-
Kasuga-shi, Japan, 816-0864
- Recruiting
- Research Site
-
Kawasaki-shi, Japan, 216-8511
- Recruiting
- Research Site
-
Koshigaya-shi, Japan, 343-8555
- Completed
- Research Site
-
Kumagaya-shi, Japan, 360-0197
- Completed
- Research Site
-
Kumamoto, Japan, 860-0008
- Recruiting
- Research Site
-
Kusatsu-shi, Japan, 525-8585
- Withdrawn
- Research Site
-
Kyoto, Japan, 612-8555
- Recruiting
- Research Site
-
Kyoto, Japan, 602-8566
- Withdrawn
- Research Site
-
Maebashi, Japan, 371-0811
- Recruiting
- Research Site
-
Meguro-ku, Japan, 152-8902
- Recruiting
- Research Site
-
Mitaka-shi, Japan, 181-8611
- Recruiting
- Research Site
-
Nagoya, Japan, 466-8560
- Withdrawn
- Research Site
-
Nerima-ku, Japan, 179-0072
- Recruiting
- Research Site
-
Okayama, Japan, 702-8055
- Withdrawn
- Research Site
-
Okazaki-shi, Japan, 444-0827
- Recruiting
- Research Site
-
Omuta-shi, Japan, 837-0911
- Recruiting
- Research Site
-
Osaka, Japan, 545-8586
- Recruiting
- Research Site
-
Osaka, Japan, 543-0035
- Recruiting
- Research Site
-
Osaka, Japan, 534-0021
- Recruiting
- Research Site
-
Sapporo, Japan, 062-0931
- Completed
- Research Site
-
Sapporo, Japan, 063-0005
- Recruiting
- Research Site
-
Shinagawa-ku, Japan, 142-8666
- Withdrawn
- Research Site
-
Shinjuku-ku, Japan, 162-8655
- Completed
- Research Site
-
Suita-shi, Japan, 565-0871
- Withdrawn
- Research Site
-
Tachikawa-shi, Japan, 190-8531
- Recruiting
- Research Site
-
Takamatsu, Japan, 760-0018
- Completed
- Research Site
-
Urasoe-shi, Japan, 901-2132
- Recruiting
- Research Site
-
Ureshino-shi, Japan, 843-0393
- Completed
- Research Site
-
Yokohama, Japan, 245-8575
- Recruiting
- Research Site
-
Yokohama, Japan, 236-0004
- Recruiting
- Research Site
-
Yokohama, Japan, 241-0811
- Withdrawn
- Research Site
-
-
-
-
-
Kota Kinabalu, Malaysia, 88200
- Completed
- Research Site
-
Kuala Lumpur, Malaysia, 50586
- Completed
- Research Site
-
Kuala Lumpur, Malaysia, 59100
- Completed
- Research Site
-
Kuala Terengganu, Malaysia, 20400
- Withdrawn
- Research Site
-
Kuantan, Malaysia, 25200
- Completed
- Research Site
-
Kubang Kerian, Malaysia, 16150
- Completed
- Research Site
-
Malacca, Malaysia, 75400
- Completed
- Research Site
-
Petaling Jaya, Malaysia, 47500
- Completed
- Research Site
-
Pulau Pinang, Malaysia, 10450
- Completed
- Research Site
-
Sarawak Miri, Malaysia, 98000
- Completed
- Research Site
-
Selangor Darul Ehsan, Malaysia, 42300
- Withdrawn
- Research Site
-
Shah Alam, Malaysia, 40000
- Completed
- Research Site
-
-
-
-
-
Aguascalientes, Mexico, 20259
- Withdrawn
- Research Site
-
Guadalajara, Mexico, 44340
- Recruiting
- Research Site
-
Guadalajara, Mexico, 44280
- Recruiting
- Research Site
-
Mexico City, Mexico, 06720
- Recruiting
- Research Site
-
Mexico City, Mexico, 06726
- Withdrawn
- Research Site
-
Monterrey, Mexico, 64460
- Recruiting
- Research Site
-
San Luis Potosí City, Mexico, 78250
- Recruiting
- Research Site
-
Tlalpan, Mexico, 14050
- Recruiting
- Research Site
-
Tlalpan, Mexico, 14080
- Not yet recruiting
- Research Site
-
Xalapa, Mexico, 91020
- Withdrawn
- Research Site
-
-
-
-
-
Cusco, Peru, CUSCO 01
- Recruiting
- Research Site
-
El Agustino, Peru, LIMA 10
- Withdrawn
- Research Site
-
Lima, Peru, LIMA 31
- Recruiting
- Research Site
-
Lima, Peru, 15088
- Withdrawn
- Research Site
-
Lima, Peru, LIMA 1
- Recruiting
- Research Site
-
Lima, Peru, LIMA 01
- Withdrawn
- Research Site
-
Lima, Peru, 15324
- Withdrawn
- Research Site
-
Lima, Peru, LIMA 11
- Recruiting
- Research Site
-
Lima, Peru, 15074
- Withdrawn
- Research Site
-
Piura, Peru, 05
- Withdrawn
- Research Site
-
-
-
-
-
Cebu, Philippines, 6000
- Completed
- Research Site
-
Iloilo City, Philippines
- Recruiting
- Research Site
-
Manila, Philippines, 1000
- Recruiting
- Research Site
-
Quezon City, Philippines, 1100
- Withdrawn
- Research Site
-
Quezon City, Philippines, 1109
- Completed
- Research Site
-
-
-
-
-
Chrzanów, Poland, 32-500
- Recruiting
- Research Site
-
Lodz, Poland, 91-347
- Terminated
- Research Site
-
Rzeszów, Poland, 35-241
- Withdrawn
- Research Site
-
Warsaw, Poland, 01-138
- Recruiting
- Research Site
-
Warsaw, Poland, 00-416
- Withdrawn
- Research Site
-
Warsaw, Poland, 04-141
- Recruiting
- Research Site
-
Wroclaw, Poland, 51-149
- Withdrawn
- Research Site
-
Łańcut, Poland, 37-100
- Recruiting
- Research Site
-
Łęczna, Poland, 21-010
- Recruiting
- Research Site
-
-
-
-
-
Bayamón, Puerto Rico, 00961
- Withdrawn
- Research Site
-
-
-
-
-
Bucharest, Romania, 010825
- Withdrawn
- Research Site
-
Bucharest, Romania, 21105
- Completed
- Research Site
-
Cluj-Napoca, Romania, 400000
- Completed
- Research Site
-
Constanța, Romania, 900709
- Completed
- Research Site
-
Iași, Romania, 700116
- Completed
- Research Site
-
Sibiu, Romania, 550245
- Completed
- Research Site
-
Timișoara, Romania, 300310
- Completed
- Research Site
-
-
-
-
-
Jeddah, Saudi Arabia, 21423
- Withdrawn
- Research Site
-
Riyadh, Saudi Arabia, 12231
- Withdrawn
- Research Site
-
Riyadh, Saudi Arabia, 11426
- Completed
- Research Site
-
Riyadh, Saudi Arabia, 12372
- Completed
- Research Site
-
-
-
-
-
Bratislava, Slovakia, 82606
- Withdrawn
- Research Site
-
-
-
-
-
Johannesburg, Soweto, South Africa, 2013
- Terminated
- Research Site
-
Observatory, South Africa, 7925
- Recruiting
- Research Site
-
Parktown, South Africa, 2193
- Recruiting
- Research Site
-
Westdene, South Africa, 2092
- Terminated
- Research Site
-
-
-
-
-
Daegu, South Korea, 42415
- Withdrawn
- Research Site
-
Jeonju, South Korea, 54907
- Withdrawn
- Research Site
-
Seoul, South Korea, 143-729
- Withdrawn
- Research Site
-
-
-
-
-
Barcelona, Spain, 08036
- Withdrawn
- Research Site
-
Barcelona, Spain, 08003
- Completed
- Research Site
-
Madrid, Spain, 28034
- Completed
- Research Site
-
Majadahonda, Spain, 28222
- Completed
- Research Site
-
Málaga, Spain, 29010
- Completed
- Research Site
-
Ourense, Spain, 32005
- Withdrawn
- Research Site
-
Palma de Mallorca, Spain, 07010
- Completed
- Research Site
-
Pamplona, Spain, 31008
- Completed
- Research Site
-
Santander, Spain, 39008
- Completed
- Research Site
-
Valencia, Spain, 46010
- Completed
- Research Site
-
-
-
-
-
Helsingborg, Sweden, 25187
- Recruiting
- Research Site
-
Huddinge, Sweden, 14157
- Recruiting
- Research Site
-
Lund, Sweden, 22185
- Recruiting
- Research Site
-
Malmö, Sweden, 20502
- Recruiting
- Research Site
-
Solna, Sweden, 17176
- Withdrawn
- Research Site
-
Stockholm, Sweden, 11861
- Recruiting
- Research Site
-
Stockholm, Sweden, 18288
- Active, not recruiting
- Research Site
-
Umeå, Sweden, 90185
- Recruiting
- Research Site
-
Västerås, Sweden, 72189
- Completed
- Research Site
-
-
-
-
-
Kaohsiung City, Taiwan, 80756
- Recruiting
- Research Site
-
Kaohsiung City, Taiwan, 81362
- Recruiting
- Research Site
-
Taichung, Taiwan, 40447
- Recruiting
- Research Site
-
Taichung, Taiwan, 40705
- Withdrawn
- Research Site
-
Taipei, Taiwan, 112
- Recruiting
- Research Site
-
Taipei, Taiwan, 0116
- Recruiting
- Research Site
-
Taipei, Taiwan, 10002
- Terminated
- Research Site
-
Taoyuan, Taiwan, 333
- Recruiting
- Research Site
-
Taoyuan City, Taiwan, 330
- Recruiting
- Research Site
-
-
-
-
-
Bangkok, Thailand, 10210
- Recruiting
- Research Site
-
Bangkok, Thailand, 10400
- Recruiting
- Research Site
-
Bangkok, Thailand, 10700
- Recruiting
- Research Site
-
Banphaeo, Thailand, 74120
- Recruiting
- Research Site
-
Chiang Mai, Thailand, 50200
- Recruiting
- Research Site
-
Khlong Luang, Thailand, 12120
- Recruiting
- Research Site
-
Khon Kaen, Thailand, 40002
- Completed
- Research Site
-
Phutthamonthon, Thailand, 73170
- Suspended
- Research Site
-
Ubonratchathani, Thailand, 34000
- Withdrawn
- Research Site
-
-
-
-
-
Ankara, Turkey (Türkiye), 06800
- Suspended
- Research Site
-
Diyarbakır, Turkey (Türkiye), 21280
- Recruiting
- Research Site
-
Istanbul, Turkey (Türkiye), 34010
- Withdrawn
- Research Site
-
Istanbul, Turkey (Türkiye), 34303
- Recruiting
- Research Site
-
Istanbul, Turkey (Türkiye), 34899
- Recruiting
- Research Site
-
Istanbul, Turkey (Türkiye), 34069
- Terminated
- Research Site
-
Izmir, Turkey (Türkiye), 35040
- Suspended
- Research Site
-
Izmir, Turkey (Türkiye), 35110
- Suspended
- Research Site
-
Malatya, Turkey (Türkiye), 44280
- Suspended
- Research Site
-
Ortahisar, Turkey (Türkiye), 61080
- Recruiting
- Research Site
-
İzmit, Turkey (Türkiye), 41000
- Suspended
- Research Site
-
-
-
-
-
Bristol, United Kingdom, BS105NB
- Recruiting
- Research Site
-
Dundee, United Kingdom, DD1 9SY
- Recruiting
- Research Site
-
Glasgow, United Kingdom, G51 4TF
- Withdrawn
- Research Site
-
Glasgow, United Kingdom, G4 0SF
- Completed
- Research Site
-
Hampshire, United Kingdom, SO16 6YD
- Recruiting
- Research Site
-
Huddersfield, United Kingdom, HD3 3EA
- Recruiting
- Research Site
-
Leeds, United Kingdom, LS9 7TF
- Recruiting
- Research Site
-
Leicester, United Kingdom, LE3 9QP
- Recruiting
- Research Site
-
London, United Kingdom, W2 1NY
- Recruiting
- Research Site
-
London, United Kingdom, W1T 7HA
- Recruiting
- Research Site
-
London, United Kingdom, W6 8RF
- Withdrawn
- Research Site
-
Oxford, United Kingdom, OX3 9DU
- Recruiting
- Research Site
-
Prescot, United Kingdom, L35 5DR
- Recruiting
- Research Site
-
Tyne and Wear, United Kingdom, NE29 8NH
- Recruiting
- Research Site
-
Wythenshawe, United Kingdom, M23 9LT
- Withdrawn
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Not yet recruiting
- Research Site
-
Mobile, Alabama, United States, 36608
- Recruiting
- Research Site
-
-
Arizona
-
Phoenix, Arizona, United States, 85013
- Withdrawn
- Research Site
-
Phoenix, Arizona, United States, 85008
- Completed
- Research Site
-
Tucson, Arizona, United States, 85719
- Recruiting
- Research Site
-
-
California
-
Chula Vista, California, United States, 91911
- Withdrawn
- Research Site
-
Fresno, California, United States, 93701
- Recruiting
- Research Site
-
La Mesa, California, United States, 91942
- Withdrawn
- Research Site
-
Los Angeles, California, United States, 90027
- Withdrawn
- Research Site
-
Newport Beach, California, United States, 92663
- Recruiting
- Research Site
-
Torrance, California, United States, 90505
- Recruiting
- Research Site
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80909
- Recruiting
- Research Site
-
Denver, Colorado, United States, 80206
- Withdrawn
- Research Site
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20037
- Recruiting
- Research Site
-
-
Florida
-
Bradenton, Florida, United States, 34209
- Withdrawn
- Research Site
-
Bradenton, Florida, United States, 34209
- Completed
- Research Site
-
Gainesville, Florida, United States, 32611
- Recruiting
- Research Site
-
Jacksonville, Florida, United States, 32224
- Recruiting
- Research Site
-
Lakeland, Florida, United States, 33805
- Recruiting
- Research Site
-
Miami, Florida, United States, 33144
- Withdrawn
- Research Site
-
South Pasadena, Florida, United States, 33707
- Completed
- Research Site
-
St. Petersburg, Florida, United States, 33709
- Withdrawn
- Research Site
-
Tampa, Florida, United States, 33617
- Recruiting
- Research Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Withdrawn
- Research Site
-
-
Idaho
-
Boise, Idaho, United States, 83702
- Recruiting
- Research Site
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Completed
- Research Site
-
Elmhurst, Illinois, United States, 60126
- Withdrawn
- Research Site
-
Evanston, Illinois, United States, 60201
- Recruiting
- Research Site
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46804
- Withdrawn
- Research Site
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Withdrawn
- Research Site
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Withdrawn
- Research Site
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Research Site
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Research Site
-
New Orleans, Louisiana, United States, 70121
- Withdrawn
- Research Site
-
Shreveport, Louisiana, United States, 71103
- Completed
- Research Site
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Recruiting
- Research Site
-
Silver Spring, Maryland, United States, 20910
- Completed
- Research Site
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01199
- Completed
- Research Site
-
Worcester, Massachusetts, United States, 01655
- Completed
- Research Site
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Research Site
-
Detroit, Michigan, United States, 48202
- Withdrawn
- Research Site
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Research Site
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Research Site
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Completed
- Research Site
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Research Site
-
St Louis, Missouri, United States, 63110
- Recruiting
- Research Site
-
-
New York
-
Brooklyn, New York, United States, 11203
- Withdrawn
- Research Site
-
Buffalo, New York, United States, 14203
- Not yet recruiting
- Research Site
-
New York, New York, United States, 10016
- Withdrawn
- Research Site
-
New York, New York, United States, 10039
- Recruiting
- Research Site
-
Potsdam, New York, United States, 13676
- Completed
- Research Site
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Withdrawn
- Research Site
-
Durham, North Carolina, United States, 27705
- Not yet recruiting
- Research Site
-
Greenville, North Carolina, United States, 27834
- Withdrawn
- Research Site
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Research Site
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Withdrawn
- Research Site
-
Columbus, Ohio, United States, 43210
- Recruiting
- Research Site
-
Toledo, Ohio, United States, 43614
- Not yet recruiting
- Research Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Research Site
-
-
Oregon
-
Corvallis, Oregon, United States, 97330
- Completed
- Research Site
-
Portland, Oregon, United States, 97239
- Withdrawn
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Withdrawn
- Research Site
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Completed
- Research Site
-
-
South Carolina
-
Greenville, South Carolina, United States, 29605
- Recruiting
- Research Site
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57105
- Withdrawn
- Research Site
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Not yet recruiting
- Research Site
-
Dallas, Texas, United States, 75204
- Recruiting
- Research Site
-
Dallas, Texas, United States, 75203
- Completed
- Research Site
-
El Paso, Texas, United States, 79905
- Recruiting
- Research Site
-
Houston, Texas, United States, 77090
- Withdrawn
- Research Site
-
Houston, Texas, United States, 77030
- Completed
- Research Site
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Recruiting
- Research Site
-
Salt Lake City, Utah, United States, 84132
- Not yet recruiting
- Research Site
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- Research Site
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54311
- Completed
- Research Site
-
Milwaukee, Wisconsin, United States, 53295
- Withdrawn
- Research Site
-
-
-
-
-
Haiphong, Vietnam, 180000
- Recruiting
- Research Site
-
Haiphong, Vietnam, 180000
- Withdrawn
- Research Site
-
Hanoi, Vietnam, 100000
- Recruiting
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Recruiting
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Not yet recruiting
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Withdrawn
- Research Site
-
Ho Chi Minh City, Vietnam
- Withdrawn
- Research Site
-
Hochiminh City, Vietnam, 700000
- Recruiting
- Research Site
-
Huế, Vietnam, 530000
- Recruiting
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tozorakimab
Approximately 2870 participants will be randomized in a 1:1 ratio.
Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
|
Single IV dose of tozorakimab on Day 1.
Other Names:
|
|
Placebo Comparator: Placebo
Approximately 2870 participants will be randomized in a 1:1 ratio.
Arm 2 (n=approximately 1435) will receive matching placebo.
|
Single IV dose of matching placebo on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Time Frame: by Day 28
|
To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
|
by Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants who die
Time Frame: by Day 60
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality.
|
by Day 60
|
|
Proportion of participants who die
Time Frame: by Day 28
|
To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
|
by Day 28
|
|
Proportion of participants with Intensive Care Unit (ICU) admission or death
Time Frame: by Day 28
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
|
by Day 28
|
|
Proportion of participants with Intensive Care Unit (ICU) admission or death
Time Frame: by Day 60
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
|
by Day 60
|
|
Proportion of participants alive and discharged
Time Frame: by Day 28
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
|
by Day 28
|
|
Proportion of participants alive and discharged
Time Frame: by Day 60
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
|
by Day 60
|
|
World Health Organization (WHO) 10-category ordinal Clinical Progression Scale
Time Frame: by Day 60
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale (0 least severe to 10 most severe).
|
by Day 60
|
|
Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint
Time Frame: Day 1
|
To evaluate the use of baseline serum IL-33/sST2 complex levels (U/mL) to predict treatment response with tozorakimab versus placebo as add on to Standard of Care (SoC).
|
Day 1
|
|
Number of days alive and outside of Intensive Care Unit (ICU)
Time Frame: over 28 day period
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.
|
over 28 day period
|
|
Number of days alive and free of supplemental oxygen
Time Frame: over 28 day period
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.
|
over 28 day period
|
|
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Time Frame: by Day 60
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
|
by Day 60
|
|
Time to death (all cause)
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
|
over 28 day and 60 day period
|
|
Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
|
over 28 day and 60 day period
|
|
Number of days alive and ventilator free
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
|
over 28 day and 60 day period
|
|
Time to discharge
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
|
over 28 day and 60 day period
|
|
Time to being off supplemental oxygen
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
|
over 28 day and 60 day period
|
|
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Time Frame: over 28 day and 60 day period
|
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
|
over 28 day and 60 day period
|
|
Presence of anti-drug antibodies
Time Frame: over 60 day period
|
To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.
|
over 60 day period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2022
Primary Completion (Estimated)
November 4, 2027
Study Completion (Estimated)
November 4, 2027
Study Registration Dates
First Submitted
November 11, 2022
First Submitted That Met QC Criteria
November 18, 2022
First Posted (Actual)
November 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Orthomyxoviridae Infections
- RNA Virus Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Influenza, Human
- Lung Diseases
- Respiratory Distress Syndrome
- Infections
- Virus Diseases
- Respiratory Tract Infections
- Coronavirus Infections
- Severe Acute Respiratory Syndrome
- Substandard Drugs
- Pharmaceutical Preparations
- Counterfeit Drugs
Other Study ID Numbers
- D9185C00001
- 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
- 2022-003107-15 (EudraCT Number)
- 2023-507031-38-00 (Registry Identifier: CTIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.