Viral Lung Infection and Acute Respiratory FailurePhase 3TILIANCT05624450

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

A Phase 3 study testing Tozorakimab in people with Viral Lung Infection and Acute Respiratory Failure, run by AstraZeneca at 471 sites in 39 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Viral Lung Infection and Acute Respiratory Failure
What is being tested?: Tozorakimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,527 participants
Where: 471 sitesin 39 countries
Study dates: 13 Dec 2022to 4 Nov 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

471 sites in 39 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

471 sites in 39 countries

United States78 sites, 38 recruiting

Research Site
Amarillo, Texas, 79106
Not yet recruiting
Research Site
Annapolis, Maryland, 21401
Recruiting
Research Site
Atlanta, Georgia, 30322
Withdrawn
Research Site
Baton Rouge, Louisiana, 70808
Recruiting
Research Site
Birmingham, Alabama, 35294
Not yet recruiting
Research Site
Boise, Idaho, 83702
Recruiting
Research Site
Bradenton, Florida, 34209
Completed
Research Site
Bradenton, Florida, 34209
Withdrawn
Research Site
Brooklyn, New York, 11203
Withdrawn
Research Site
Buffalo, New York, 14203
Not yet recruiting
Research Site
Chapel Hill, North Carolina, 27514
Withdrawn
Research Site
Charlottesville, Virginia, 22908
Recruiting
Research Site
Chicago, Illinois, 60612
Completed
Research Site
Chula Vista, California, 91911
Withdrawn
Research Site
Cleveland, Ohio, 44195
Withdrawn
Research Site
Colorado Springs, Colorado, 80909
Recruiting
Research Site
Columbia, Missouri, 65212
Completed
Research Site
Columbus, Ohio, 43210
Recruiting
Research Site
Corvallis, Oregon, 97330
Completed
Research Site
Dallas, Texas, 75203
Completed
Research Site
Dallas, Texas, 75204
Recruiting
Research Site
Denver, Colorado, 80206
Withdrawn
Research Site
Detroit, Michigan, 48202
Recruiting
Research Site
Detroit, Michigan, 48202
Withdrawn
Research Site
Durham, North Carolina, 27705
Not yet recruiting
Research Site
El Paso, Texas, 79905
Recruiting
Research Site
Elmhurst, Illinois, 60126
Withdrawn
Research Site
Evanston, Illinois, 60201
Recruiting
Research Site
Fort Wayne, Indiana, 46804
Withdrawn
Research Site
Fresno, California, 93701
Recruiting
Research Site
Gainesville, Florida, 32611
Recruiting
Research Site
Green Bay, Wisconsin, 54311
Completed
Research Site
Greenville, North Carolina, 27834
Withdrawn
Research Site
Greenville, South Carolina, 29605
Recruiting
Research Site
Houston, Texas, 77030
Completed
Research Site
Houston, Texas, 77090
Withdrawn
Research Site
Iowa City, Iowa, 52242
Withdrawn
Research Site
Jacksonville, Florida, 32224
Recruiting
Research Site
Kansas City, Kansas, 66160
Withdrawn
Research Site
Kansas City, Missouri, 64108
Recruiting
Research Site
La Mesa, California, 91942
Withdrawn
Research Site
Lakeland, Florida, 33805
Recruiting
Research Site
Los Angeles, California, 90027
Withdrawn
Research Site
Louisville, Kentucky, 40202
Recruiting
Research Site
Miami, Florida, 33144
Withdrawn
Research Site
Milwaukee, Wisconsin, 53295
Withdrawn
Research Site
Mobile, Alabama, 36608
Recruiting
Research Site
New Orleans, Louisiana, 70121
Withdrawn
Research Site
New York, New York, 10016
Withdrawn
Research Site
New York, New York, 10039
Recruiting
Research Site
Newport Beach, California, 92663
Recruiting
Research Site
Oklahoma City, Oklahoma, 73104
Recruiting
Research Site
Philadelphia, Pennsylvania, 19107
Withdrawn
Research Site
Phoenix, Arizona, 85008
Completed
Research Site
Phoenix, Arizona, 85013
Withdrawn
Research Site
Pittsburgh, Pennsylvania, 15213
Not yet recruiting
Research Site
Portland, Oregon, 97239
Withdrawn
Research Site
Potsdam, New York, 13676
Completed
Research Site
Providence, Rhode Island, 02903
Completed
Research Site
Providence, Rhode Island, 02903
Not yet recruiting
Research Site
Royal Oak, Michigan, 48073
Recruiting
Research Site
Saint Paul, Minnesota, 55101
Recruiting
Research Site
Salt Lake City, Utah, 84107
Recruiting
Research Site
Salt Lake City, Utah, 84132
Not yet recruiting
Research Site
Shreveport, Louisiana, 71103
Completed
Research Site
Silver Spring, Maryland, 20910
Completed
Research Site
Sioux Falls, South Dakota, 57105
Withdrawn
Research Site
South Pasadena, Florida, 33707
Completed
Research Site
Springfield, Massachusetts, 01199
Completed
Research Site
St Louis, Missouri, 63110
Recruiting
Research Site
St. Petersburg, Florida, 33709
Withdrawn
Research Site
Tampa, Florida, 33617
Recruiting
Research Site
Toledo, Ohio, 43614
Recruiting
Research Site
Torrance, California, 90505
Recruiting
Research Site
Tucson, Arizona, 85719
Recruiting
Research Site
Washington D.C., District of Columbia, 20037
Recruiting
Research Site
Winston-Salem, North Carolina, 27157
Recruiting
Research Site
Worcester, Massachusetts, 01655
Completed

Other trials in United States

Japan46 sites, 29 recruiting

Research Site
Chiba, 260-0852
Recruiting
Research Site
Fukuoka, 814-0180
Recruiting
Research Site
Gifu, 502-8558
Recruiting
Research Site
Ginowan-shi, 901-2725
Recruiting
Research Site
Hanyu-shi, 348-8505
Recruiting
Research Site
Hiroshima, 734-8530
Recruiting
Research Site
Hiroshima, 734-8551
Withdrawn
Research Site
Hitachi-shi, 317-0077
Recruiting
Research Site
Isehara-shi, 259-1193
Recruiting
Research Site
Izumisano, 598-8577
Withdrawn
Research Site
Izumo-shi, 693-8501
Recruiting
Research Site
Kamakura-shi, 247-8533
Recruiting
Research Site
Kamogawa-shi, 296-8602
Withdrawn
Research Site
Kanazawa, 920-8641
Withdrawn
Research Site
Kanazawa, 920-8650
Recruiting
Research Site
Kasuga-shi, 816-0864
Recruiting
Research Site
Kawasaki-shi, 216-8511
Recruiting
Research Site
Koshigaya-shi, 343-8555
Completed
Research Site
Kumagaya-shi, 360-0197
Completed
Research Site
Kumamoto, 860-0008
Recruiting
Research Site
Kusatsu-shi, 525-8585
Withdrawn
Research Site
Kyoto, 602-8566
Withdrawn
Research Site
Kyoto, 612-8555
Recruiting
Research Site
Maebashi, 371-0811
Recruiting
Research Site
Meguro-ku, 152-8902
Recruiting
Research Site
Mitaka-shi, 181-8611
Recruiting
Research Site
Nagoya, 466-8560
Withdrawn
Research Site
Nerima-ku, 179-0072
Recruiting
Research Site
Okayama, 702-8055
Withdrawn
Research Site
Okazaki-shi, 444-0827
Recruiting
Research Site
Omuta-shi, 837-0911
Recruiting
Research Site
Osaka, 534-0021
Recruiting
Research Site
Osaka, 543-0035
Recruiting
Research Site
Osaka, 545-8586
Recruiting
Research Site
Sapporo, 062-0931
Completed
Research Site
Sapporo, 063-0005
Recruiting
Research Site
Shinagawa-ku, 142-8666
Withdrawn
Research Site
Shinjuku-ku, 162-8655
Completed
Research Site
Suita-shi, 565-0871
Withdrawn
Research Site
Tachikawa-shi, 190-8531
Recruiting
Research Site
Takamatsu, 760-0018
Completed
Research Site
Urasoe-shi, 901-2132
Recruiting
Research Site
Ureshino-shi, 843-0393
Completed
Research Site
Yokohama, 236-0004
Recruiting
Research Site
Yokohama, 241-0811
Withdrawn
Research Site
Yokohama, 245-8575
Recruiting

Other trials in Japan

China42 sites, 38 recruiting

Research Site
Anyang, 455099
Recruiting
Research Site
Beijing, 100015
Recruiting
Research Site
Beijing, 100029
Recruiting
Research Site
Beijing, 101199
Recruiting
Research Site
Beijing
Recruiting
Research Site
Changchun, 130041
Recruiting
Research Site
Changsha, 410004
Recruiting
Research Site
Changsha, 410015
Recruiting
Research Site
Chengdu, 610000
Recruiting
Research Site
Chengdu, 610072
Recruiting
Research Site
Chongqing, 400010
Recruiting
Research Site
Chongqing, 402160
Not yet recruiting
Research Site
Fuyang, 236012
Recruiting
Research Site
Guangzhou, 510180
Recruiting
Research Site
Guangzhou, 510515
Withdrawn
Research Site
Haikou, 570311
Recruiting
Research Site
Hangzhou, 310006
Recruiting
Research Site
Hangzhou, 310016
Withdrawn
Research Site
Hefei, 230001
Withdrawn
Research Site
Jinhua, 321099
Recruiting
Research Site
Jining, 272006
Recruiting
Research Site
Nanchang, 330006
Recruiting
Research Site
Nanjing, 211100
Recruiting
Research Site
Nantong, 226001
Recruiting
Research Site
Ningbo, 315010
Recruiting
Research Site
Qingdao, 266011
Recruiting
Research Site
Shanghai, 200025
Recruiting
Research Site
Shanghai, 200032
Recruiting
Research Site
Shanghai, 200240
Recruiting
Research Site
Shanghai, 201199
Recruiting
Research Site
Shanghai, CN-200433
Recruiting
Research Site
Shenzhen, 518020
Recruiting
Research Site
Tianjin, 300050
Recruiting
Research Site
Weifang, 261041
Recruiting
Research Site
Wuhan, 430023
Withdrawn
Research Site
Wuhan, 430030
Recruiting
Research Site
Xinxiang, 453100
Recruiting
Research Site
Yangzhou, 225001
Recruiting
Research Site
Yantai, 264000
Recruiting
Research Site
Yinchuan, 750004
Recruiting
Research Site
Yueyang, 414000
Recruiting
Research Site
Zhengzhou, 450000
Recruiting

Other trials in China

Brazil20 sites, 9 recruiting

Research Site
Belo Horizonte, 30150-221
Withdrawn
Research Site
Campinas, 13060-803
Recruiting
Research Site
Caxias do Sul, 95070-560
Recruiting
Research Site
Curitiba, 80215-901
Completed
Research Site
Curitiba, 80730-150
Completed
Research Site
Indaiatuba, 13331-501
Completed
Research Site
Jaú, 17201-130
Recruiting
Research Site
Natal, 59025-050
Recruiting
Research Site
Niterói, 24020-096
Withdrawn
Research Site
Passo Fundo, 99010-260
Recruiting
Research Site
Porto Alegre, 90020-090
Completed
Research Site
Porto Alegre, 9061-000
Recruiting
Research Site
Recife, 50070-070
Withdrawn
Research Site
Ribeirão Preto, 14049-901
Withdrawn
Research Site
Rio de Janeiro, 21040-900
Recruiting
Research Site
Salvador, 40170-130
Completed
Research Site
São Caetano do Sul, 09521-160
Recruiting
Research Site
São José do Rio Preto, 15090-000
Recruiting
Research Site
São Paulo, 04004-030
Withdrawn
Research Site
São Paulo, 09323-900
Completed

Other trials in Brazil

India17 sites, 8 recruiting

Research Site
Ahmedabad, 380054
Suspended
Research Site
Ahmedabad, 382415
Terminated
Research Site
Belagavi, 590010
Recruiting
Research Site
Chennai, 600113
Suspended
Research Site
Dehradun, 248001
Recruiting
Research Site
Gūrgaon, 122001
Recruiting
Research Site
Gurugram, 122001
Withdrawn
Research Site
Hyderabad, 500035
Suspended
Research Site
Hyderabad, 500068
Recruiting
Research Site
Kanpur, 208002
Recruiting
Research Site
Mumbai, 400008
Withdrawn
Research Site
New Delhi, 110017
Recruiting
Research Site
New Delhi, 110029
Recruiting
Research Site
New Delhi, 110060
Withdrawn
Research Site
Pune, 411043
Terminated
Research Site
Thane, 401107
Terminated
Research Site
Vijayawada, 520 008
Recruiting

Other trials in India

Canada15 sites, 11 recruiting

Research Site
Brampton, Ontario, L6R 3J9
Recruiting
Research Site
Calgary, Alberta, T2N 1N4
Recruiting
Research Site
Lévis, Quebec, G6V 3Z1
Recruiting
Research Site
Montreal, Quebec, H1T 2M4
Recruiting
Research Site
Montreal, Quebec, H2W 1S6
Recruiting
Research Site
Montreal, Quebec, H2X 3E4
Recruiting
Research Site
New Westminster, British Columbia, V3L 3W7
Withdrawn
Research Site
Ottawa, Ontario, K1H 8L6
Recruiting
Research Site
Ottawa, Ontario, K1Y 4E9
Recruiting
Research Site
Québec, Quebec, G1V 4G5
Recruiting
Research Site
Saskatoon, Saskatchewan, S7N 0W8
Recruiting
Research Site
Toronto, Ontario, M4N 3M5
Recruiting
Research Site
Winnipeg, Manitoba, R2H 2A6
Withdrawn
Research Site
Winnipeg, Manitoba, R3A 1R9
Withdrawn
Research Site
Winnipeg, Manitoba, R3J 3M7
Withdrawn

Other trials in Canada

United Kingdom15 sites, 11 recruiting

Research Site
Bristol, BS105NB
Recruiting
Research Site
Dundee, DD1 9SY
Recruiting
Research Site
Glasgow, G4 0SF
Completed
Research Site
Glasgow, G51 4TF
Withdrawn
Research Site
Hampshire, SO16 6YD
Recruiting
Research Site
Huddersfield, HD3 3EA
Recruiting
Research Site
Leeds, LS9 7TF
Recruiting
Research Site
Leicester, LE3 9QP
Recruiting
Research Site
London, W1T 7HA
Recruiting
Research Site
London, W2 1NY
Recruiting
Research Site
London, W6 8RF
Withdrawn
Research Site
Oxford, OX3 9DU
Recruiting
Research Site
Prescot, L35 5DR
Recruiting
Research Site
Tyne and Wear, NE29 8NH
Recruiting
Research Site
Wythenshawe, M23 9LT
Withdrawn

Other trials in United Kingdom

France13 sites, 12 recruiting

Research Site
Amiens, 80054
Recruiting
Research Site
Angers, 49033
Recruiting
Research Site
Brest, 29609
Recruiting
Research Site
Créteil, 94000
Recruiting
Research Site
Dijon, 21000
Recruiting
Research Site
La Tronche, 38700
Recruiting
Research Site
Le Coudray, 28630
Recruiting
Research Site
Montpellier, 34295
Recruiting
Research Site
Nantes, 44800
Recruiting
Research Site
Orléans, 45100
Recruiting
Research Site
Strasbourg, 67091
Recruiting
Research Site
Strasbourg, 67098
Completed
Research Site
Tours, 37000
Recruiting

Other trials in France

Germany12 sites, 8 recruiting

Research Site
Augsburg, 86156
Recruiting
Research Site
Berlin, 10117
Terminated
Research Site
Berlin, 12351
Recruiting
Research Site
Cologne, 51109
Recruiting
Research Site
Hamburg, 20246
Completed
Research Site
Hanover, 30625
Recruiting
Research Site
Kiel, 24105
Recruiting
Research Site
Leverkusen, 51375
Completed
Research Site
Marburg, 35043
Recruiting
Research Site
Regensburg, 93053
Withdrawn
Research Site
Rosenheim, 83022
Recruiting
Research Site
Rostock, 18057
Recruiting

Other trials in Germany

Malaysia12 sites

Research Site
Kota Kinabalu, 88200
Completed
Research Site
Kuala Lumpur, 50586
Completed
Research Site
Kuala Lumpur, 59100
Completed
Research Site
Kuala Terengganu, 20400
Withdrawn
Research Site
Kuantan, 25200
Completed
Research Site
Kubang Kerian, 16150
Completed
Research Site
Malacca, 75400
Completed
Research Site
Petaling Jaya, 47500
Completed
Research Site
Pulau Pinang, 10450
Completed
Research Site
Sarawak Miri, 98000
Completed
Research Site
Selangor Darul Ehsan, 42300
Withdrawn
Research Site
Shah Alam, 40000
Completed

Other trials in Malaysia

Thailand11 sites, 8 recruiting

Research Site
Bangkok, 10210
Recruiting
Research Site
Bangkok, 10400
Recruiting
Research Site
Bangkok, 10700
Recruiting
Research Site
Banphaeo, 74120
Recruiting
Research Site
Chiang Mai, 50200
Recruiting
Research Site
Khlong Luang, 12120
Recruiting
Research Site
Khon Kaen, 40002
Completed
Research Site
Muang, 11000
Not yet recruiting
Research Site
Muang, 70000
Not yet recruiting
Research Site
Phutthamonthon, 73170
Suspended
Research Site
Ubonratchathani, 34000
Withdrawn

Other trials in Thailand

Turkey (Türkiye)11 sites, 4 recruiting

Research Site
Ankara, 06800
Suspended
Research Site
Diyarbakır, 21280
Recruiting
Research Site
Istanbul, 34010
Withdrawn
Research Site
Istanbul, 34069
Terminated
Research Site
Istanbul, 34303
Recruiting
Research Site
Istanbul, 34899
Recruiting
Research Site
Izmir, 35040
Suspended
Research Site
Izmir, 35110
Suspended
Research Site
İzmit, 41000
Suspended
Research Site
Malatya, 44280
Suspended
Research Site
Ortahisar, 61080
Recruiting

Other trials in Turkey (Türkiye)

Bulgaria10 sites

Research Site
Montana, 3400
Withdrawn
Research Site
Pernik, 2300
Suspended
Research Site
Pleven, 5800
Suspended
Research Site
Rousse, 7002
Suspended
Research Site
Sofia, 1000
Withdrawn
Research Site
Sofia, 1154
Withdrawn
Research Site
Sofia, 1407
Withdrawn
Research Site
Sofia, 1431
Withdrawn
Research Site
Sofia, 1606
Suspended
Research Site
Varna, 9010
Withdrawn

Other trials in Bulgaria

Denmark10 sites, 10 recruiting

Research Site
Aalborg, 9000
Recruiting
Research Site
Aarhus N, 8200
Recruiting
Research Site
Copenhagen, 2400
Recruiting
Research Site
Copenhagen Ø, 2100
Recruiting
Research Site
Herning, 7400
Recruiting
Research Site
Hillerød, 3400
Recruiting
Research Site
Hvidovre, 2650
Recruiting
Research Site
Kolding, 6000
Recruiting
Research Site
Odense C, 5000
Recruiting
Research Site
Vejle, 7100
Recruiting

Other trials in Denmark

Mexico10 sites, 7 recruiting

Research Site
Aguascalientes, 20259
Withdrawn
Research Site
Guadalajara, 44280
Recruiting
Research Site
Guadalajara, 44340
Recruiting
Research Site
Mexico City, 06720
Recruiting
Research Site
Mexico City, 06726
Withdrawn
Research Site
Monterrey, 64460
Recruiting
Research Site
San Luis Potosí City, 78250
Recruiting
Research Site
Tlalpan, 14050
Recruiting
Research Site
Tlalpan, 14080
Not yet recruiting
Research Site
Xalapa, 91020
Withdrawn

Other trials in Mexico

Peru10 sites, 4 recruiting

Research Site
Cusco, CUSCO 01
Recruiting
Research Site
El Agustino, LIMA 10
Withdrawn
Research Site
Lima, 15074
Withdrawn
Research Site
Lima, 15088
Withdrawn
Research Site
Lima, 15324
Withdrawn
Research Site
Lima, LIMA 01
Withdrawn
Research Site
Lima, LIMA 11
Recruiting
Research Site
Lima, LIMA 1
Recruiting
Research Site
Lima, LIMA 31
Recruiting
Research Site
Piura, 05
Withdrawn

Other trials in Peru

Spain10 sites

Research Site
Barcelona, 08003
Completed
Research Site
Barcelona, 08036
Withdrawn
Research Site
Madrid, 28034
Completed
Research Site
Majadahonda, 28222
Completed
Research Site
Málaga, 29010
Completed
Research Site
Ourense, 32005
Withdrawn
Research Site
Palma de Mallorca, 07010
Completed
Research Site
Pamplona, 31008
Completed
Research Site
Santander, 39008
Completed
Research Site
Valencia, 46010
Completed

Other trials in Spain

Argentina9 sites, 3 recruiting

Research Site
Buenos Aires, C1046
Completed
Research Site
Buenos Aires, C1120AAF
Completed
Research Site
Buenos Aires, C1180AAV
Recruiting
Research Site
CABA, C1221ADC
Completed
Research Site
CABA, C1425EOE
Withdrawn
Research Site
La Plata, B1900AVG
Recruiting
Research Site
Mar del Plata, B7600GWV
Completed
Research Site
Munro, B1605FRE
Recruiting
Research Site
Rosario, S2000CVB
Completed

Other trials in Argentina

Czechia9 sites, 2 recruiting

Research Site
Benešov, 256 01
Completed
Research Site
Brno, 625 00
Completed
Research Site
Hradec Králové, 500 05
Withdrawn
Research Site
Kolín, 280 02
Recruiting
Research Site
Kyjov, 697 01
Completed
Research Site
Mladá Boleslav, 293 01
Completed
Research Site
Prague, 100 34
Withdrawn
Research Site
Prague, 150 30
Withdrawn
Research Site
Prague, 18000
Recruiting

Other trials in Czechia

Hungary9 sites, 5 recruiting

Research Site
Balassagyarmat, 2660
Completed
Research Site
Budapest, 1082
Recruiting
Research Site
Budapest, 1121
Completed
Research Site
Debrecen, 4032
Recruiting
Research Site
Győr, 9024
Completed
Research Site
Kaposvár, 7400
Recruiting
Research Site
Kistarcsa, 2143
Withdrawn
Research Site
Nyíregyháza, 4400
Recruiting
Research Site
Pécs, 7624
Recruiting

Other trials in Hungary

Israel9 sites, 7 recruiting

Research Site
Afula, 18341
Recruiting
Research Site
Ashkelon, 7830604
Recruiting
Research Site
Beersheba, 8410101
Withdrawn
Research Site
Haifa, 34362
Recruiting
Research Site
Holon, 58100
Recruiting
Research Site
Jerusalem, 91120
Recruiting
Research Site
Petah Tikva, 4941492
Terminated
Research Site
Ramat Gan, 52621
Recruiting
Research Site
Rehovot, 76100
Recruiting

Other trials in Israel

Poland9 sites, 5 recruiting

Research Site
Chrzanów, 32-500
Recruiting
Research Site
Łańcut, 37-100
Recruiting
Research Site
Łęczna, 21-010
Recruiting
Research Site
Lodz, 91-347
Terminated
Research Site
Rzeszów, 35-241
Withdrawn
Research Site
Warsaw, 00-416
Withdrawn
Research Site
Warsaw, 01-138
Recruiting
Research Site
Warsaw, 04-141
Recruiting
Research Site
Wroclaw, 51-149
Withdrawn

Other trials in Poland

Sweden9 sites, 6 recruiting

Research Site
Helsingborg, 25187
Recruiting
Research Site
Huddinge, 14157
Recruiting
Research Site
Lund, 22185
Recruiting
Research Site
Malmö, 20502
Recruiting
Research Site
Solna, 17176
Withdrawn
Research Site
Stockholm, 11861
Recruiting
Research Site
Stockholm, 18288
Active, not recruiting
Research Site
Umeå, 90185
Recruiting
Research Site
Västerås, 72189
Completed

Other trials in Sweden

Taiwan9 sites, 7 recruiting

Research Site
Kaohsiung City, 80756
Recruiting
Research Site
Kaohsiung City, 81362
Recruiting
Research Site
Taichung, 40447
Recruiting
Research Site
Taichung, 40705
Withdrawn
Research Site
Taipei, 0116
Recruiting
Research Site
Taipei, 10002
Terminated
Research Site
Taipei, 112
Recruiting
Research Site
Taoyuan, 333
Recruiting
Research Site
Taoyuan City, 330
Recruiting

Other trials in Taiwan

Vietnam9 sites, 6 recruiting

Research Site
Haiphong, 180000
Recruiting
Research Site
Haiphong, 180000
Withdrawn
Research Site
Hanoi, 100000
Recruiting
Research Site
Ho Chi Minh City, 700000
Withdrawn
Research Site
Ho Chi Minh City, 700000
Recruiting
Research Site
Ho Chi Minh City, 700000
Not yet recruiting
Research Site
Ho Chi Minh City
Withdrawn
Research Site
Hochiminh City, 700000
Recruiting
Research Site
Huế, 530000
Recruiting

Other trials in Vietnam

Italy7 sites, 3 recruiting

Research Site
Arezzo, 52100
Completed
Research Site
Brescia, 25123
Completed
Research Site
Naples, 80131
Recruiting
Research Site
Roma, 00128
Recruiting
Research Site
Roma, 00149
Completed
Research Site
Rozzano, 20089
Recruiting
Research Site
Torino, 10149
Completed

Other trials in Italy

Romania7 sites

Research Site
Bucharest, 010825
Withdrawn
Research Site
Bucharest, 21105
Completed
Research Site
Cluj-Napoca, 400000
Completed
Research Site
Constanța, 900709
Completed
Research Site
Iași, 700116
Completed
Research Site
Sibiu, 550245
Completed
Research Site
Timișoara, 300310
Completed

Other trials in Romania

Greece6 sites, 4 recruiting

Research Site
Athens, 11527
Withdrawn
Research Site
Athens, 12462
Recruiting
Research Site
Exohi Thessaloniki, 57010
Recruiting
Research Site
Heraklion, 71500
Recruiting
Research Site
Ioannina, 45500
Recruiting
Research Site
Thessaloniki, 57010
Completed

Other trials in Greece

Australia5 sites, 4 recruiting

Research Site
Adelaide, 5000
Recruiting
Research Site
Bedford Park, 5042
Recruiting
Research Site
New Lambton Heights, 2305
Completed
Research Site
Port Macquarie, 2444
Recruiting
Research Site
South Brisbane, 4101
Recruiting

Other trials in Australia

Colombia5 sites

Research Site
Bogota DC, 111121
Withdrawn
Research Site
Floridablanca, 681004
Completed
Research Site
Medellín, 050021
Completed
Research Site
Soledad, 083001
Completed
Research Site
Villavicencio, 500001
Completed

Other trials in Colombia

Philippines5 sites, 2 recruiting

Research Site
Cebu, 6000
Completed
Research Site
Iloilo City
Recruiting
Research Site
Manila, 1000
Recruiting
Research Site
Quezon City, 1100
Withdrawn
Research Site
Quezon City, 1109
Completed

Other trials in Philippines

Belgium4 sites, 4 recruiting

Research Site
Kortrijk, 8500
Recruiting
Research Site
Ottignies, 1340
Recruiting
Research Site
Roeselare, 8800
Recruiting
Research Site
Yvoir, 5530
Recruiting

Other trials in Belgium

Egypt4 sites

Research Site
Alexandria, 21131
Withdrawn
Research Site
Cairo, 11561
Withdrawn
Research Site
Cairo, 11566
Withdrawn
Research Site
New Cairo, 11566
Withdrawn

Other trials in Egypt

Saudi Arabia4 sites

Research Site
Jeddah, 21423
Withdrawn
Research Site
Riyadh, 11426
Completed
Research Site
Riyadh, 12231
Withdrawn
Research Site
Riyadh, 12372
Completed

Other trials in Saudi Arabia

South Africa4 sites, 2 recruiting

Research Site
Johannesburg, Soweto, 2013
Terminated
Research Site
Observatory, 7925
Recruiting
Research Site
Parktown, 2193
Recruiting
Research Site
Westdene, 2092
Terminated

Other trials in South Africa

South Korea3 sites

Research Site
Daegu, 42415
Withdrawn
Research Site
Jeonju, 54907
Withdrawn
Research Site
Seoul, 143-729
Withdrawn

Other trials in South Korea

Hong Kong1 site

Research Site
Hong Kong, 999077
Withdrawn

Other trials in Hong Kong

Puerto Rico1 site

Research Site
Bayamón, 00961
Withdrawn

Other trials in Puerto Rico

Slovakia1 site

Research Site
Bratislava, 82606
Withdrawn

Other trials in Slovakia

About this study

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

Conditions: Viral Lung Infection and Acute Respiratory Failure
Being tested: Tozorakimab, Placebo
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
Medical subject headings: Respiratory Distress Syndrome, COVID-19, Coronavirus Infections, Virus Diseases, Severe Acute Respiratory Syndrome, Respiratory Tract Infections, Infections, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TozorakimabDrug
Also called MEDI3506
Single IV dose of tozorakimab on Day 1.
PlaceboDrug
Single IV dose of matching placebo on Day 1.

Study groups in NCT05624450
Study group	Role	What they receive
Tozorakimab	Experimental	Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab. Receives: Drug: Tozorakimab
Placebo	Placebo comparator	Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
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.
Measured: by Day 28

Secondary outcomes (18)

Proportion of participants who die
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality.
Measured: by Day 60
Number of days alive and outside of Intensive Care Unit (ICU)
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.
Measured: over 28 day period
Number of days alive and free of supplemental oxygen
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.
Measured: over 28 day period
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
Measured: over 28 day and 60 day period
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
Measured: by Day 60
Time to death (all cause)
To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
Measured: over 28 day and 60 day period
Proportion of participants who die
To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
Measured: by Day 28
Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
Measured: over 28 day and 60 day period
Number of days alive and ventilator free
To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
Measured: over 28 day and 60 day period
Proportion of participants with Intensive Care Unit (ICU) admission or death
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
Measured: by Day 28
Proportion of participants with Intensive Care Unit (ICU) admission or death
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
Measured: by Day 60
Proportion of participants alive and discharged
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Measured: by Day 28
Proportion of participants alive and discharged
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Measured: by Day 60
Time to discharge
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Measured: over 28 day and 60 day period
Time to being off supplemental oxygen
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Measured: over 28 day and 60 day period
World Health Organization (WHO) 10-category ordinal Clinical Progression Scale
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).
Measured: by Day 60
Presence of anti-drug antibodies
To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.
Measured: over 60 day period
Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint
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).
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20224 Nov 2027

First posted22 Nov 2022
Study start13 Dec 2022
Primary completion4 Nov 2027 (estimated)
Study completion4 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Viral Lung Infection and Acute Respiratory FailureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 3,527 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05624450
Sponsor's protocol ID: D9185C00001
Other IDs: 2023-507031-38-00, 2022-003107-15, 2023
Acronym: TILIA
Status last verified: Sep 2026
First submitted: 11 Nov 2022
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.