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Search / Trial NCT05624450

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

Launched by ASTRAZENECA · Nov 18, 2022

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Acute Respiratory Failure Acute Respiratory Distress Syndrome Viral Lung Infection Tozorakimab Supplemental Oxygen Il 33 Covid 19 Sars Co V 2 Coronavirus Infections Virus Diseases Sars Coronavirus Medi3506 Respiratory Tract Infections Infections Lung Diseases Influenza

ClinConnect Summary

This clinical trial is studying a new medication called tozorakimab to see how well it works for adults who are hospitalized with a viral lung infection and need extra oxygen. The main goal is to find out if adding tozorakimab to the standard care can help prevent patients from getting worse or dying. This is important because some patients with viral lung infections can develop serious problems that require more intensive treatment, like being put on a breathing machine.

To be eligible for this trial, participants need to be at least 18 years old and must be hospitalized with a viral lung infection that is causing low oxygen levels in their blood. This is determined by certain tests, like how much oxygen is in their blood and whether they show signs of needing help to breathe. The trial is currently looking for all adult patients who meet these criteria. If someone joins the trial, they will receive either the new medication or a placebo (a treatment that looks like the real one but has no active ingredients), along with the usual care for their condition. It's a chance to contribute to research that could improve treatment for viral lung infections in the future.

Gender

ALL

Eligibility criteria

  • 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.

About Astrazeneca

AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Houston, Texas, United States

Charlottesville, Virginia, United States

Hong Kong, , Hong Kong

Varna, , Bulgaria

Detroit, Michigan, United States

Praha 10, , Czechia

Nyíregyháza, , Hungary

Mexico City, , Mexico

Malaga, , Spain

Denver, Colorado, United States

Iloilo City, , Philippines

Louisville, Kentucky, United States

New York, New York, United States

Columbus, Ohio, United States

Berlin, , Germany

Kiel, , Germany

Barcelona, , Spain

Portland, Oregon, United States

Roeselare, , Belgium

Yvoir, , Belgium

Toronto, Ontario, Canada

Jerusalem, , Israel

Napoli, , Italy

Phoenix, Arizona, United States

Evanston, Illinois, United States

New Orleans, Louisiana, United States

Roma, , Italy

Barcelona, , Spain

Dundee, , United Kingdom

Iowa City, Iowa, United States

Baton Rouge, Louisiana, United States

Oklahoma City, Oklahoma, United States

Strasbourg, , France

Hannover, , Germany

Regensburg, , Germany

Athens, , Greece

Málaga, , Spain

Oxford, , United Kingdom

Boise, Idaho, United States

Rehovot, , Israel

Madrid, , Spain

Chicago, Illinois, United States

Kansas City, Kansas, United States

Worcester, Massachusetts, United States

Debrecen, , Hungary

Levis, Quebec, Canada

Mobile, Alabama, United States

Annapolis, Maryland, United States

Saint Louis, Missouri, United States

Winston Salem, North Carolina, United States

Philadelphia, Pennsylvania, United States

Pleven, , Bulgaria

Montreal, Quebec, Canada

Benesov, , Czechia

Hvidovre, , Denmark

Hamburg, , Germany

Haifa, , Israel

Holon, , Israel

Arezzo, , Italy

Sibiu, , Romania

Timisoara, , Romania

Leeds, , United Kingdom

Leicester, , United Kingdom

Atlanta, Georgia, United States

Los Angeles, California, United States

Aguascalientes, , Mexico

Washington, District Of Columbia, United States

Lakeland, Florida, United States

Kortrijk, , Belgium

Ottignies, , Belgium

Augsburg, , Germany

Marburg, , Germany

München, , Germany

Ioannina, , Greece

Thessaloniki, , Greece

London, , United Kingdom

Brescia, , Italy

Shreveport, Louisiana, United States

Houston, Texas, United States

Ottawa, Ontario, Canada

Ramat Gan, , Israel

Lund, , Sweden

Providence, Rhode Island, United States

Miami, Florida, United States

Greenville, North Carolina, United States

Quezon City, , Philippines

Manila, , Philippines

Taichung, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Saskatoon, Saskatchewan, Canada

Valencia, , Spain

Adelaide, , Australia

South Brisbane, , Australia

Brno, , Czechia

Springfield, Massachusetts, United States

Phoenix, Arizona, United States

Jacksonville, Florida, United States

Ruse, , Bulgaria

New Delhi, , India

New Delhi, , India

Bratislava, , Slovakia

Warszawa, , Poland

Sioux Falls, South Dakota, United States

El Paso, Texas, United States

Green Bay, Wisconsin, United States

Beijing, , China

Shanghai, , China

Athens, , Greece

Taichung, , Taiwan

Sofia, , Bulgaria

Brest Cedex, , France

Rozzano, , Italy

Roma, , Italy

Hradec Kralove, , Czechia

Budapest, , Hungary

London, , United Kingdom

Majadahonda, , Spain

Phoenix, Arizona, United States

Fort Wayne, Indiana, United States

Brooklyn, New York, United States

Fresno, California, United States

Newport Beach, California, United States

Elmhurst, Illinois, United States

Corvallis, Oregon, United States

Bayamon, , Puerto Rico

Kyoto Shi, , Japan

Mitaka Shi, , Japan

Ubonratchathani, , Thailand

Herning, , Denmark

Vejle, , Denmark

Dijon, , France

La Mesa, California, United States

Torrance, California, United States

Campinas, , Brazil

Sliven, , Bulgaria

Chongqing, , China

Yinchuan, , China

Pécs, , Hungary

Kuala Lumpur, , Malaysia

Cebu, , Philippines

łęczna, , Poland

Parktown, , South Africa

Soweto, , South Africa

Kaohsiung, , Taiwan

Salt Lake City, Utah, United States

Glasgow, , United Kingdom

Observatory, , South Africa

Aalborg, , Denmark

Amiens Cedex 1, , France

Colorado Springs, Colorado, United States

Stockholm, , Sweden

Umeå, , Sweden

Malmö, , Sweden

Pamplona, , Spain

Milwaukee, Wisconsin, United States

Chula Vista, California, United States

Chengdu, , China

Suita Shi, , Japan

Monterrey, , Mexico

Kistarcsa, , Hungary

Royal Oak, Michigan, United States

Gainesville, Florida, United States

Leverkusen, , Germany

Odense C, , Denmark

Montpellier Cedex 5, , France

Saint Petersburg, Florida, United States

São José Do Rio Preto, , Brazil

Quebec, , Canada

Nanchang, , China

Kasuga Shi, , Japan

Yokohama Shi, , Japan

Chrzanów, , Poland

Košice, , Slovakia

Hanoi, , Vietnam

Fresno, California, United States

Winnipeg, Manitoba, Canada

La Tronche, , France

Le Coudray Cedex, , France

Meguro Ku, , Japan

Shinjuku Ku, , Japan

Ankara, , Turkey

Malatya, , Turkey

Ho Chi Minh, , Vietnam

Columbia, Missouri, United States

Mlada Boleslav, , Czechia

Aarhus N, , Denmark

København, , Denmark

Melaka, , Malaysia

Santander, , Spain

Hillerød, , Denmark

Strasbourg Cedex, , France

Shenzhen, , China

Zhengzhou, , China

Wuhan, , China

Kawasaki Shi, , Japan

Daegu, , Korea, Republic Of

Taoyuan, , Taiwan

Győr, , Hungary

Beer Sheva, , Israel

Lima, , Peru

Izmir, , Turkey

Silver Spring, Maryland, United States

Kyoto Shi, , Japan

Bradenton, Florida, United States

Porto Alegre, , Brazil

Floridablanca, , Colombia

Kolding, , Denmark

Petah Tikva, , Israel

Hitachi Shi, , Japan

Isehara Shi, , Japan

Kumamoto Shi, , Japan

Takamatsu Shi, , Japan

Urasoe Shi, , Japan

Ureshino Shi, , Japan

Guadalajara, , Mexico

Riyadh, , Saudi Arabia

Shinagawa Ku, , Japan

Cusco, , Peru

Palma De Mallorca, , Spain

Balassagyarmat, , Hungary

Osaka Shi, , Japan

Shatin, , Hong Kong

Tianjin, , China

Yueyang, , China

Bedford Park, , Australia

Port Macquarie, , Australia

Trnava, , Slovakia

Izumo Shi, , Japan

Rzeszów, , Poland

Okayama Shi, , Japan

Atlanta, Georgia, United States

Haikou, , China

Hai Phong, , Vietnam

Huddersfield, , United Kingdom

Potsdam, New York, United States

Pernik, , Bulgaria

Orléans Cedex 2, , France

Warszawa, , Poland

Mumbai, , India

Vijayawada, , India

Kubang Kerian, , Malaysia

Xalapa, , Mexico

Taipei, , Taiwan

Izmir, , Turkey

Hue, , Vietnam

Tucson, Arizona, United States

Montana, , Bulgaria

Angers, , France

Tours, , France

New Lambton Heights, , Australia

Rostock, , Germany

London, , United Kingdom

Saint Paul, Minnesota, United States

Kanazawa Shi, , Japan

Istanbul, , Turkey

Kyjov, , Czechia

Hefei, , China

Köln, , Germany

Nagoya Shi, , Japan

Hangzhou, , China

Belo Horizonte, , Brazil

Medellin, , Colombia

Osaka Shi, , Japan

Changsha, , China

Rosenheim, , Germany

Yantai, , China

Alexandria, , Egypt

Guangzhou, , China

Fukuoka Shi, , Japan

Kagoshima Shi, , Japan

Koshigaya Shi, , Japan

Guadalajara, , Mexico

Gurgaon, , India

Kolin, , Czechia

Rio De Janeiro, , Brazil

Hanyu Shi, , Japan

Ashkelon, , Israel

Plovdiv, , Bulgaria

Belagavi, , India

Kanpur, , India

Kusatsu Shi, , Japan

Tachikawa Shi, , Japan

Caxias Do Sul, , Brazil

Kamakura Shi, , Japan

Trnava, , Slovakia

Bangkok, , Thailand

Pune, , India

Kuala Lumpur, , Malaysia

Pulau Pinang, , Malaysia

Chengdu, , China

Chapel Hill, North Carolina, United States

Omuta Shi, , Japan

Jeddah, , Saudi Arabia

Nantong, , China

Khlong Luang, , Thailand

Diyarbakir, , Turkey

Ourense, , Spain

Lima, , Peru

Calgary, Alberta, Canada

Hyderabad, , India

Thane, , India

Nakagami Gun, , Japan

New Cairo, , Egypt

Yokohama Shi, , Japan

Qingdao, , China

Weifang, , China

Wythenshawe, , United Kingdom

Maebashi Shi, , Japan

Soledad, , Colombia

Sapporo Shi, , Japan

Mar Del Plata, , Argentina

Sao Jose Do Rio Preto, , Brazil

Chiba Shi, , Japan

Créteil, , France

Istanbul, , Turkey

Rosario, , Argentina

Dallas, Texas, United States

Curitiba, , Brazil

Copenhagen ø, , Denmark

Bristol, , United Kingdom

Tlalpan, , Mexico

Seoul, , Korea, Republic Of

Exohi Thessaloniki, , Greece

Munro, , Argentina

Kuantan, , Malaysia

Lima, , Peru

Solna, , Sweden

Gurugram, , India

Natal, , Brazil

Hampshire, , United Kingdom

Montréal, Quebec, Canada

Jeonju, , Korea, Republic Of

Niterói, , Brazil

Beijing, , China

Afula, , Israel

Heraklion, , Greece

Passo Fundo, , Brazil

Ahmedabad, , India

Ribeirão Preto, , Brazil

New York, New York, United States

Bogota Dc, , Colombia

Villavicencio, , Colombia

Torino, , Italy

Sarawak Miri, , Malaysia

El Agustino, , Peru

Piura, , Peru

Västerås, , Sweden

Khon Kaen, , Thailand

Istambul, , Turkey

Prescot, , United Kingdom

Tyne And Wear, , United Kingdom

Sao Paulo, , Brazil

Ciudad Autónoma De Buenos Aires, , Argentina

Praha 5, , Czechia

Nantes Cedex 1, , France

Chennai, , India

Okazaki Shi, , Japan

Petaling Jaya, , Malaysia

Shah Alam, , Malaysia

Salvador, , Brazil

Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aire, , Argentina

La Plata, , Argentina

São Paulo, , Brazil

Brampton, Ontario, Canada

San Luis Potosi, , Mexico

Taoyuan City, , Taiwan

Hochiminh City, , Vietnam

Izumisano Shi, , Japan

Hiroshima Shi, , Japan

Gifu Shi, , Japan

Kamogawa Shi, , Japan

Phutthamonthon, , Thailand

South Pasadena, Florida, United States

Caba, , Argentina

Fuyang, , China

Wuhan, , China

Wroclaw, , Poland

łódź, , Poland

Bucharest, , Romania

Westdene, , South Africa

Kuala Terengganu, , Malaysia

Recife, , Brazil

Buenos Aires, , Argentina

Kota Kinabalu, , Malaysia

Aguascalientes, , Mexico

Cairo, , Egypt

Nerima Ku, , Japan

Kumagaya Shi, , Japan

Helsingborg, , Sweden

Huddinge, , Sweden

Johannesburg, Soweto, , South Africa

Cluj Napoca, , Romania

Ciudad De México, , Mexico

Hyderabad, , India

Constanta, , Romania

Iasi, , Romania

Hong Kong, , Hong Kong

Pune, , India

Jaú, , Brazil

İzmit, , Turkey

Tampa, Florida, United States

New Westminster, British Columbia, Canada

łańcut, , Poland

Stockholm, , Sweden

Banphaeo, , Thailand

Jining, , China

Praha, , Czechia

Selangor Darul Ehsan, , Malaysia

Ortahisar, , Turkey

Indaiatuba, , Brazil

São Caetano Do Sul, , Brazil

Ginowan Shi, , Japan

Bucharest, , Romania

Tianjin, , China

Petah Tikva, , Israel

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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