Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
NCT ID: NCT04723394
Last Updated: 2023-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
910 participants
INTERVENTIONAL
2021-01-28
2022-10-19
Brief Summary
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Detailed Description
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There is an urgent need to rapidly evaluate treatments in the non-hospitalized setting to prevent progression and reduce serious complications of COVID-19, as well as its transmission.
As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease.
AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.
Enrollment of up to approximately 1700 participants is planned.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD7442
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442.
AZD7442
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Placebo
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo.
Placebo
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Interventions
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AZD7442
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Placebo
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. WHO Clinical Progression Scale score \> 1 and \< 4.
3. Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as the self-reported date of first reported sign/symptom.
4. One or more of the following signs/symptoms must be present within 24 hours prior to Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or smell.
5. Oxygenation saturation of ≥ 92% obtained at rest by study staff within 24 hours prior to Day 1 (unless participant regularly receives chronic supplementary oxygen for an underlying lung condition).
6. Participant agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days after entry into the study (whichever is earliest).
7. Participant must be ≥ 18 years of age, provide informed consent and is able to comply with study requirements/procedures.
8. Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 90 days following administration of IMP.
9. Women of childbearing potential must use one highly effective form of birth control.
Exclusion Criteria
2. Current need for hospitalization/immediate medical attention in a clinic/emergency room service
3. Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any time prior to entry into this study or expected administration immediately after enrollment.
5. Current requirement or anticipated impending need for mechanical ventilation.
6. Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
7. Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
8. Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry, unless a stable dose is used for a chronic condition.
9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or expected receipt of IMP during the study follow-up period, or concurrent participation in another interventional study.
10. Pregnant or breastfeeding women.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Jasper, Alabama, United States
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Tucson, Arizona, United States
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Long Beach, California, United States
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Northridge, California, United States
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Cutler Bay, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Pompano Beach, Florida, United States
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Chicago, Illinois, United States
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Lake Charles, Louisiana, United States
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St Louis, Missouri, United States
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La Vista, Nebraska, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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West Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Munro, , Argentina
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Blumenau, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Hradec Králové, , Czechia
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Kolín, , Czechia
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Svitavy, , Czechia
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Friedrichshain, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Koblenz, , Germany
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Mainz, , Germany
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München, , Germany
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München-Pasing, , Germany
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Debrecen, , Hungary
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Gyöngyös, , Hungary
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Guastalla, , Italy
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Milan, , Italy
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Piacenza, , Italy
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Pisa, , Italy
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Roma, , Italy
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Chiba, , Japan
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Hachioji-shi, , Japan
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Iruma-Gun, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Narita-shi, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Chihuahua City, , Mexico
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Cuauhtémoc, , Mexico
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Cuautitlán Izcalli, , Mexico
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Ecatepec de Morelos, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mazatlán, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Tlalpan, , Mexico
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Tlalpan, , Mexico
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Lima, , Peru
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Rzeszów, , Poland
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Wołomin, , Poland
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Moscow, , Russia
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Murmansk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Cabra, , Spain
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Centelles (Barcelona), , Spain
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Girona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kherson, , Ukraine
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Blackpool, , United Kingdom
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Bracknell, , United Kingdom
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
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Connor Downs, , United Kingdom
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Highgate, , United Kingdom
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Leicester, , United Kingdom
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Preston, , United Kingdom
Research Site
Rochdale, , United Kingdom
Countries
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References
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Ashraf-Kashani and Kumar 2017 Ashraf-Kashani N, Kumar R. High-flow nasal oxygen therapy. BJA Education. 2017;17:57-62.
Gou and Xi 2019 Gou J, Xi D. Hierarchical testing of a primary and a secondary endpoint in a group sequential design with different information times. Statistics in Biopharmaceutical Research. 2019;11(4):398-406, DOI: 10.1080/19466315.2018.1546613.
ICMRA 2020 International Coalition of Medicines Regulatory Authorities. Global regulatory workshop on COVID-19 therapeutics: agreement on acceptable endpoints for clinical trials. Published online July 2020. Retrieved from http://icmra.info/drupal/news/20july2020/summary
Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.
Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985 Apr-Jun;4(2):213-26. doi: 10.1002/sim.4780040211.
Sharma S, Danckers M, Sanghavi DK, Chakraborty RK. High-Flow Nasal Cannula. 2023 Apr 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526071/
Tamhane AC, Mehta CR, Liu L. Testing a primary and a secondary endpoint in a group sequential design. Biometrics. 2010 Dec;66(4):1174-84. doi: 10.1111/j.1541-0420.2010.01402.x.
WHO 2020 WHO COVID-19 Dashboard. Available from: https://covid19.who.int
WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.
CDC, 2021 CDC, Investigating the Impact of COVID-19 during Pregnancy, available from https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/special-populations/pregnancy-data-on-covid-19/what-cdc-is-doing.html
CDC, Growth Charts CDC, Growth Charts, available from https://www.cdc.gov/growthcharts/clinical_charts.htm
Lilly BLAZE-1 2021 Lilly. Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19. Published online 10 March 2021. Accessed 31 March 2021. https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-and-etesevimab-together-reduced
Regeneron Pharmaceuticals, Inc. REGEN-COV Outpatient Trial 2021 Regeneron Pharmaceuticals, Inc. Phase 3 trial shows Regen-Cov™ (casirivimab with imdevimab) antibody cocktail reduced hospitalization or death by 70% in non-hospitalized Covid-19 patients. Published online 23 March 2021. Accessed 31 March 2021. https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody#:~:text=This%20definitive%20Phase%203%20outcomes,71%25%20(2%2C400%20mg%20IV)
Hobbs FDR, Montgomery H, Padilla F, Simon-Campos JA, Arbetter D, Seegobin S, Kiazand A, Streicher K, Martinez-Alier N, Cohen TS, Esser MT. Safety, Efficacy and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Treatment of Mild-to-Moderate COVID-19: 15-Month Final Analysis of the TACKLE Trial. Infect Dis Ther. 2024 Mar;13(3):521-533. doi: 10.1007/s40121-024-00931-4. Epub 2024 Feb 25.
Hobbs FDR, Montgomery H, Padilla F, Simon-Campos JA, Kim K, Arbetter D, Padilla KW, Reddy VP, Seegobin S, Streicher K, Templeton A, Viani RM, Johnsson E, Koh GCKW, Esser MT. Outpatient Treatment with AZD7442 (Tixagevimab/Cilgavimab) Prevented COVID-19 Hospitalizations over 6 Months and Reduced Symptom Progression in the TACKLE Randomized Trial. Infect Dis Ther. 2023 Sep;12(9):2269-2287. doi: 10.1007/s40121-023-00861-7. Epub 2023 Sep 26.
Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S, Kim K, Campos JAS, Arends RH, Brodek BH, Brooks D, Garbes P, Jimenez J, Koh GCKW, Padilla KW, Streicher K, Viani RM, Alagappan V, Pangalos MN, Esser MT; TACKLE study group. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2022 Oct;10(10):985-996. doi: 10.1016/S2213-2600(22)00180-1. Epub 2022 Jun 7.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D8851C00001
Identifier Type: -
Identifier Source: org_study_id
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