COVID-19Phase 3TACKLENCT04723394
Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
A Phase 3 study testing AZD7442 in people with COVID-19, run by AstraZeneca at 103 sites in 15 countries.
Trial summary
This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- AZD7442
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 910 participants
- Where
- 103 sitesin 15 countries
- Study dates
- 28 Jan 2021to 19 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.
- WHO Clinical Progression Scale score > 1 and < 4.
- 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.
- 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.
- 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).
- 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).
Show all 9Show fewer
- Participant must be ≥ 18 years of age, provide informed consent and is able to comply with study requirements/procedures.
- 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.
- Women of childbearing potential must use one highly effective form of birth control.
Who cannot join
- History or current hospitalization for COVID-19.
- Current need for hospitalization/immediate medical attention in a clinic/emergency room service
- Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
- 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.
- Current requirement or anticipated impending need for mechanical ventilation.
- Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
Show all 10Show fewer
- Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
- 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.
- 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.
- Pregnant or breastfeeding women.
Trial locations and contacts
103 sites in 15 countries.
103 sites in 15 countries
United States24 sites
Research Site
Charlotte, North Carolina, 28208
Research Site
Charlotte, North Carolina, 28277
Research Site
Chicago, Illinois, 60621
Research Site
Columbus, Ohio, 43213
Research Site
Cutler Bay, Florida, 33157
Research Site
Dallas, Texas, 75235
Research Site
Fargo, North Dakota, 58104
Research Site
Houston, Texas, 77027
Research Site
Houston, Texas, 77057
Research Site
Houston, Texas, 77093
Research Site
Humble, Texas, 77338
Research Site
Jasper, Alabama, 35501
Research Site
La Vista, Nebraska, 68128
Research Site
Lake Charles, Louisiana, 70601
Research Site
Long Beach, California, 90806
Research Site
Miami, Florida, 33125
Research Site
Miami, Florida, 33165
Research Site
New York, New York, 10016
Research Site
Northridge, California, 91324
Research Site
Pompano Beach, Florida, 33064
Research Site
St Louis, Missouri, 63141
Research Site
Statesville, North Carolina, 28625
Research Site
Tucson, Arizona, 85704
Research Site
West Columbia, South Carolina, 29169
Germany12 sites
Research Site
Berlin, 10439
Research Site
Berlin, 10777
Research Site
Cologne, 50668
Research Site
Frankfurt, 60596
Research Site
Frankfurt am Main, 60389
Research Site
Friedrichshain, 10243
Research Site
Hamburg, 20095
Research Site
Hanover, 30625
Research Site
Koblenz, 56068
Research Site
Mainz, 55128
Research Site
München, 80336
Research Site
München-Pasing, 81241
Mexico11 sites
Research Site
Chihuahua City, 31350
Research Site
Cuauhtémoc, 06700
Research Site
Cuautitlán Izcalli, 54750
Research Site
Ecatepec de Morelos, 55450
Research Site
Guadalajara, 44100
Research Site
Guadalajara, 44200
Research Site
Mazatlán, 82110
Research Site
Mérida, 97070
Research Site
Monterrey, 64460
Research Site
Tlalpan, 14050
Research Site
Tlalpan, 14080
Japan10 sites
Research Site
Chiba, 260-0852
Research Site
Hachioji-shi, 193-0998
Research Site
Iruma-Gun, 350-0495
Research Site
Kyoto, 607-8062
Research Site
Maebashi, 371-0811
Research Site
Narita-shi, 286-8520
Research Site
Sendai, 983-8512
Research Site
Shinagawa-ku, 140-8522
Research Site
Shinagawa-ku, 142-8666
Research Site
Shinjuku-ku, 162-8655
United Kingdom9 sites
Research Site
Blackpool, FY3 7EN
Research Site
Bracknell, RG12 8WY
Research Site
Bristol, BS8 2PU
Research Site
Cambridge, CB2 2QQ
Research Site
Connor Downs, TR27 5DT
Research Site
Highgate, N19 5NF
Research Site
Leicester, LE5 4LJ
Research Site
Preston, PR2 9HT
Research Site
Rochdale, OL11 4AU
Russia7 sites
Research Site
Moscow, 143442
Research Site
Murmansk, 183047
Research Site
Saint Petersburg, 192283
Research Site
Saint Petersburg, 196084
Research Site
Saint Petersburg, 197227
Research Site
Saint Petersburg, 199106
Research Site
Saint Petersburg, 199226
Brazil5 sites
Research Site
Blumenau, 89030-101
Research Site
Porto Alegre, 90430-001
Research Site
Ribeirão Preto, 14051-140
Research Site
São Paulo, 01228-200
Research Site
Sorocaba, 18040-425
Italy5 sites
Research Site
Guastalla, 42016
Research Site
Milan, 20127
Research Site
Piacenza, 29121
Research Site
Pisa, 56124
Research Site
Roma, 00149
Spain5 sites
Research Site
Cabra, 14940
Research Site
Centelles (Barcelona), 08540
Research Site
Girona, 17005
Research Site
Madrid, 28031
Research Site
Málaga, 29010
Argentina4 sites
Research Site
Buenos Aires, B7600FYW
Research Site
Buenos Aires, C1039
Research Site
Buenos Aires, C1430EGF
Research Site
Munro, B1605FRE
Czechia3 sites
Research Site
Hradec Králové, 500 02
Research Site
Kolín, 280 02
Research Site
Svitavy, 568 25
Ukraine3 sites
Research Site
Dnipro, 49102
Research Site
Ivano-Frankivsk, 78018
Research Site
Kherson, 73000
About this study
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death.
Read the detailed description
A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe, with over 35 million confirmed cases reported and more than one million associated deaths according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare systems with significant socioeconomic impacts. Effective interventions to prevent or treat COVID-19 remain few in number and clinical experience is limited.
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
- COVID-19
- Being tested
- AZD7442, Placebo
- Keywords
- Treatment of COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7442Drug
Also called Combination of 2 mAbs (AZD8895 and AZD1061)
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
PlaceboDrug
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| AZD7442 | Experimental | 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. Receives: Drug: AZD7442 |
| Placebo | Placebo comparator | Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29
Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 < 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.
Measured: Baseline (Day 1) and Day 29
Secondary outcomes (1)
A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169
Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169
Measured: Baseline (Day 1) and Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start28 Jan 2021
- Primary completion21 Aug 2021
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723394
- Sponsor's protocol ID
- D8851C00001
- Acronym
- TACKLE
- Status last verified
- Jun 2023
- First submitted
- 14 Jan 2021
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
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.
PubMed 27578435Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985 Apr-Jun;4(2):213-26. doi: 10.1002/sim.4780040211.
PubMed 4023479Sharma S, Danckers M, Sanghavi DK, Chakraborty RK. High-Flow Nasal Cannula. 2023 Apr 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526071/
PubMed 30252327Tamhane 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.
PubMed 20337631WHO 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.
PubMed 32539990Zhou 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.
PubMed 32015507Zou 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.
PubMed 15033648CDC, 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)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
- ClinicalTrials.gov ID
- NCT04723394
- Acronym / sponsor ID
- TACKLE / D8851C00001
- Conditions
- COVID-19
- Keywords
- Treatment of COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death.
Detailed description
A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe, with over 35 million confirmed cases reported and more than one million associated deaths according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare systems with significant socioeconomic impacts. Effective interventions to prevent or treat COVID-19 remain few in number and clinical experience is limited.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7442 | Experimental | Drug: AZD7442Up 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. |
| Placebo | Placebo comparator | Drug: PlaceboUp to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.
- WHO Clinical Progression Scale score > 1 and < 4.
- 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.
- 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.
- 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).
Key exclusion criteria (10 listed)
- History or current hospitalization for COVID-19.
- Current need for hospitalization/immediate medical attention in a clinic/emergency room service
- Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
- 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.
- Current requirement or anticipated impending need for mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7442Also: Combination of 2 mAbs (AZD8895 and AZD1061)Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1. | Drug | AZD7442 |
| PlaceboSingle dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1. | Drug | Placebo |
Primary outcome
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29
Time frame: Baseline (Day 1) and Day 29
Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 < 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.
1 secondary outcome
A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169
Time frame: Baseline (Day 1) and Day 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAshraf-Kashani and Kumar 2017 Ashraf-Kashani N, Kumar R. High-flow nasal oxygen therapy. BJA Education. 2017;17:57-62.
- BackgroundGou 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.
- BackgroundICMRA 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
- Background: PubMed 27578435Li 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.
- Background: PubMed 4023479Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985 Apr-Jun;4(2):213-26. doi: 10.1002/sim.4780040211.
- Background: PubMed 30252327Sharma S, Danckers M, Sanghavi DK, Chakraborty RK. High-Flow Nasal Cannula. 2023 Apr 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526071/
- Background: PubMed 20337631Tamhane 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.
- BackgroundWHO 2020 WHO COVID-19 Dashboard. Available from: https://covid19.who.int
- Background: PubMed 32539990WHO 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.
- Background: PubMed 32015507Zhou 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.
- Background: PubMed 15033648Zou 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.
- BackgroundCDC, 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
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
103 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZD7442 in people with COVID-19, run by AstraZeneca at 103 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Germany, Mexico, Japan, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29 (time frame: Baseline (Day 1) and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723394, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.