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COVID-19Phase 3STORM CHASERNCT04625972

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults

A Phase 3 study testing AZD7442 in people with COVID-19, run by AstraZeneca at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults. Read more about this study

Who is it for?
Ages 18 to 120 years
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
1,131 participants
Where
57 sitesin 2 countries
Study dates
2 Dec 2020to 25 Jul 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age at the time of signing the informed consent
  • Adults with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic
  • Participants must not have had COVID-19 symptoms within 10 days of dosing
  • Negative result from point of care SARS-CoV-2 serology test at screening
  • Contraception used by women of childbearing potential, condom by men
  • Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Who cannot join

  • History of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 seropositivity at screening.
  • History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
  • Known history of allergy or reaction to any component of the study drug formulation.
  • Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
  • Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow up.
  • Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
Show all 12Show fewer
  • Any other significant disease, disorder, or finding that, in the judgement of the investigator, may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
  • Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
  • Currently pregnant or breast feeding.
  • Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
  • Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD7442 program, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
  • In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded.

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States50 sites

  • Research Site

    Alexandria, Virginia, 22311

  • Research Site

    Atlanta, Georgia, 30328

  • Research Site

    Bakersfield, California, 93309

  • Research Site

    Bethesda, Maryland, 20814

  • Research Site

    Buford, Georgia, 30519

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Chicago, Illinois, 60640

  • Research Site

    Conyers, Georgia, 30094

  • Research Site

    Coral Gables, Florida, 33134

  • Research Site

    Coral Springs, Florida, 33071

  • Research Site

    Corona, California, 92882

  • Research Site

    Dallas, Texas, 75235

  • Research Site

    El Paso, Texas, 79930

  • Research Site

    Friendswood, Texas, 77546

  • Research Site

    Garden Grove, California, 92844

  • Research Site

    Gonzales, Texas, 78629

  • Research Site

    Guntersville, Alabama, 35976

  • Research Site

    Harlingen, Texas, 78550

  • Research Site

    Hazel Crest, Illinois, 60429-2196

  • Research Site

    High Point, North Carolina, 27262

  • Research Site

    Houston, Texas, 77099

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Huntington Park, California, 90255

  • Research Site

    Little Rock, Arkansas, 72205

  • Research Site

    Miami, Florida, 33125

  • Research Site

    Miami, Florida, 33155

  • Research Site

    Miami, Florida, 33175

  • Research Site

    Miami, Florida, 33256

  • Research Site

    Miami Lakes, Florida, 33014

  • Research Site

    Miami Lakes, Florida, 33016

  • Research Site

    Miami Springs, Florida, 33166

  • Research Site

    Modesto, California, 95350

  • Research Site

    Mt. Dora, Florida, 32757

  • Research Site

    Noblesville, Indiana, 46060

  • Research Site

    North Miami, Florida, 33161

  • Research Site

    Orangeburg, South Carolina, 29118

  • Research Site

    Owensboro, Kentucky, 42303

  • Research Site

    Pembroke Pines, Florida, 33024

  • Research Site

    Pompano Beach, Florida, 33064

  • Research Site

    Portsmouth, Virginia, 23708

  • Research Site

    Richmond, Virginia, 23226

  • Research Site

    Riverton, Utah, 84096

  • Research Site

    San Antonio, Texas, 78215

  • Research Site

    Tacoma, Washington, 98402

  • Research Site

    Tampa, Florida, 33603

  • Research Site

    Tempe, Arizona, 85284

  • Research Site

    West Des Moines, Iowa, 50266

  • Research Site

    West Palm Beach, Florida, 33409

  • Research Site

    Wichita, Kansas, 67205

  • Research Site

    Wilmington, North Carolina, 28401

Other trials in United States

United Kingdom7 sites

  • Research Site

    Bournemouth, BH7 7DW

  • Research Site

    Hayle, TR27 5DT

  • Research Site

    London, EC1A 7BE

  • Research Site

    London, SE5 8AZ

  • Research Site

    London, WC1E 6ER

  • Research Site

    Manchester, M8 5RB

  • Research Site

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19

This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.

Read the detailed description

SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September 2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective interventions to prevent or treat COVID-19 remain limited in number and clinical experience is limited. Clinical management is limited to supportive care, consequently overwhelming resources of healthcare systems around the world. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 S 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 prevent and/or treat COVID-19. There is currently one ongoing Phase I study with AZD7442.

Conditions
COVID-19
Being tested
AZD7442, Placebo
Keywords
Post exposure 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 A combination of 2 mAbs (AZD8895 and AZD1061)

    Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.

  • PlaceboDrug

    Single dose (× 2 IM injections) of saline placebo on Day 1.

Study groups in NCT04625972
Study groupRoleWhat they receive
AZD7442ExperimentalParticipants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.
Receives: Drug: AZD7442
PlaceboPlacebo comparatorParticipants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness

    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19

    Measured: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date

  2. AEs, SAEs, MAAEs, and AESIs Post Dose of IMP

    Measured: 457 Days

Secondary outcomes (6)

  1. The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP

    Measured: 183 Days

  2. The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies

    Measured: 366 Days

  3. The Incidence of COVID-19-related Death Occurring After Dosing With IMP

    Measured: 366 Days

  4. The Incidence of All-cause Mortality Occurring After Dosing With IMP

    Measured: 366 Days

  5. Serum AZD7442 Concentrations, PK Parameters

    Measured: 457 Days

  6. Incidence of ADA to AZD7442 in Serum

    Measured: 457 Days

Timeline

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

  1. First posted12 Nov 2020
  2. Study start2 Dec 2020
  3. Primary completion7 Apr 2021
  4. Study completion25 Jul 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625972
Sponsor's protocol ID
D8850C00003
Other IDs
2020-004719-28
Acronym
STORM CHASER
Status last verified
Nov 2023
First submitted
10 Nov 2020
Last updated
21 Nov 2023
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

Publications

  • CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Published 2020. Accessed 01 July 2020.

  • Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

    PubMed 32123347

  • 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 27578435

  • Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985 Apr-Jun;4(2):213-26. doi: 10.1002/sim.4780040211.

    PubMed 4023479

  • WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.

  • WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.

  • Xie Y, Wang Z, Liao H, Marley G, Wu D, Tang W. Epidemiologic, clinical, and laboratory findings of the COVID-19 in the current pandemic: systematic review and meta-analysis. BMC Infect Dis. 2020 Aug 31;20(1):640. doi: 10.1186/s12879-020-05371-2.

    PubMed 32867706

  • 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.

    PubMed 32015507

  • 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.

    PubMed 15033648

  • Levin MJ, Ustianowski A, De Wit S, Beavon R, Thissen J, Seegobin S, Dey K, Near KA, Streicher K, Kiazand A, Esser MT. Efficacy, Safety, and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Prevention of Symptomatic COVID-19: 15-Month Final Analysis of the PROVENT and STORM CHASER Trials. Infect Dis Ther. 2024 Jun;13(6):1253-1268. doi: 10.1007/s40121-024-00970-x. Epub 2024 May 4.

    PubMed 38703336

  • Levin MJ, Ustianowski A, Thomas S, Templeton A, Yuan Y, Seegobin S, Houlihan CF, Menendez-Perez I, Pollett S, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Ivanov S, Near KA, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; COVID-19 Study to Optimally Reduce Morbidity in CareHomes and Sites with Enhanced Risk (STORMCHASER) Study Group. AZD7442 (Tixagevimab/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019. Clin Infect Dis. 2023 Apr 3;76(7):1247-1256. doi: 10.1093/cid/ciac899.

    PubMed 36411267

  • Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

    PubMed 35713300

  • 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.

    PubMed 34473343

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 57 sites in 2 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 6 inclusion and 12 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, United Kingdom. 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 25 Oct 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?

Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness (time frame: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date). The study lists 2 primary outcomes in all. 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 NCT04625972, which also lists 13 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 21 Nov 2023.

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