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CompletedNCT04625972STORM CHASERUpdated Nov 21, 2023Results posted

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

A Phase 3 interventional study of AZD7442 and Placebo in COVID-19, sponsored by AstraZeneca. Completed at 57 sites in 2 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by AstraZeneca · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,131
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • COVID-19

Browse trials for

Keywords

  • Post exposure COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,131 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥ 18 years of age at the time of signing the informed consent
  2. Adults with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic
  3. Participants must not have had COVID-19 symptoms within 10 days of dosing
  4. Negative result from point of care SARS-CoV-2 serology test at screening
  5. Contraception used by women of childbearing potential, condom by men
  6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Exclusion criteria

Exclusion Criteria:

  1. History of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 seropositivity at screening.
  2. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
  3. Known history of allergy or reaction to any component of the study drug formulation.
  4. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
  5. 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.
  6. Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
  7. 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.
  8. 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.
  9. Currently pregnant or breast feeding.
  10. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
  11. 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.
  12. 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.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,131 participants (actual)

Study arms

  • Experimental
    AZD7442

    Participants 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.

    Drug: AZD7442

  • Placebo comparator
    Placebo

    Participants 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.

    Drug: Placebo

Interventions

  • DrugAZD7442

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

    Also known as: A combination of 2 mAbs (AZD8895 and AZD1061)

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 457 Days

Secondary outcomes

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

    Time frame: 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

    Time frame: 366 Days

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

    Time frame: 366 Days

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

    Time frame: 366 Days

  5. Serum AZD7442 Concentrations, PK Parameters

    Time frame: 457 Days

  6. Incidence of ADA to AZD7442 in Serum

    Time frame: 457 Days

07

Results

Posted Oct 25, 2022
Limitations and caveats
Results are reported for the Primary analysis conducted during the study.

Participant flow

Target sample size was 1125. As this was a multi-site study there was a lag on the information of the number of participants recruited, hence we ended up with a population slightly over 1125 (N=1131).

Participant flow — Overall Study
MilestoneAZD7442Placebo
Started756375
Dosed (full analysis set)749372
Completed624304
Not completed13271
Withdrew: Death32
Withdrew: Lost to follow-up8238
Withdrew: Physician decision20
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject3724
Withdrew: Not specified elsewhere86

Outcome measures

PrimaryNumber 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

Time frame:
Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
Reported as:
Count of participants · Participants
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
ParticipantsAZD7442Placebo
Primary Analysis2317
Final analysis2824
Statistical analysis
  • AZD7442 vs Placebo · Poisson regression · p = 0.212 · Relative risk reduction: 33.31 · 95% CI -25.92 to 64.68Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.
  • AZD7442 vs Placebo · Poisson regression · p = 0.044 · Relative risk reduction: 43.28 · 95% CI 1.40 to 67.37Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.
PrimaryAEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Time frame:
457 Days
Reported as:
Number · Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
ParticipantsAZD7442Placebo
Any Adverse Event348193
Non-serious Adverse Event345191
Serious Adverse Events2016
Medically Attended Adverse Events9552
Adverse Events of Special Interest44
SecondaryThe Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
Time frame:
183 Days
Reported as:
Count of participants · Participants
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
ParticipantsAZD7442Placebo
Primary analysis01
Final Analysis01
Statistical analysis
  • AZD7442 vs Placebo · Poisson regression · p = 0.664 · Relative risk reduction: 100
SecondaryThe Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies
Time frame:
366 Days
Reported as:
Count of participants · Participants
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
ParticipantsAZD7442Placebo
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies17398
Statistical analysis
  • AZD7442 vs Placebo · Poisson regression · p = 0.163 · Relative risk reduction: 13.90 · 95% CI -6.23 to 30.21
SecondaryThe Incidence of COVID-19-related Death Occurring After Dosing With IMP
Time frame:
366 Days
Reported as:
Count of participants · Participants
The Incidence of COVID-19-related Death Occurring After Dosing With IMP
ParticipantsAZD7442Placebo
The Incidence of COVID-19-related Death Occurring After Dosing With IMP00
SecondaryThe Incidence of All-cause Mortality Occurring After Dosing With IMP
Time frame:
366 Days
Reported as:
Count of participants · Participants
The Incidence of All-cause Mortality Occurring After Dosing With IMP
ParticipantsAZD7442Placebo
The Incidence of All-cause Mortality Occurring After Dosing With IMP32
Statistical analysis
  • AZD7442 vs Placebo · Poisson regression · p = 0.744 · Relative risk reduction: 25.75 · 95% CI -343.53 to 87.57
SecondarySerum AZD7442 Concentrations, PK Parameters
Time frame:
457 Days
Reported as:
Geometric mean · µg/mL
Serum AZD7442 Concentrations, PK Parameters
µg/mLAZD7442Placebo
Day 810.028 ± 110.166—
Day 2911.718 ± 72.721—
Day 589.420 ± 75.160—
Day 927.183 ± 81.706—
Day 1832.975 ± 79.694—
Day 3660.696 ± 63.725—
SecondaryIncidence of ADA to AZD7442 in Serum
Time frame:
457 Days
Reported as:
Count of participants · Participants
Incidence of ADA to AZD7442 in Serum
ParticipantsAZD7442Placebo
Incidence of ADA to AZD7442 in Serum1106

Adverse events

Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD74423/749 (0.4%)20/749 (2.7%)345/749 (46.1%)
Placebo2/372 (0.5%)16/372 (4.3%)191/372 (51.3%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventAZD7442Placebo
Covid-19 pneumoniaInfections and infestations0/7493/372
Diabetic ketoacidosisMetabolism and nutrition disorders0/7492/372
PneumoniaInfections and infestations3/7490/372
Acute myocardial infarctionCardiac disorders0/7491/372
Burns second degreeInjury, poisoning and procedural complications0/7491/372
Coronary artery diseaseCardiac disorders0/7491/372
Toxicity to various agentsInjury, poisoning and procedural complications0/7491/372
HypoglycaemiaMetabolism and nutrition disorders1/7491/372
Trisomy 21Congenital, familial and genetic disorders0/7491/372
Ischaemic strokeNervous system disorders0/7491/372
Most frequent other events
Showing 10 of 375
Most frequent other events
EventAZD7442Placebo
Covid-19Infections and infestations117/74953/372
HeadacheNervous system disorders86/74952/372
CoughRespiratory, thoracic and mediastinal disorders80/74946/372
FatigueGeneral disorders57/74939/372
PainGeneral disorders39/74935/372
Nasal congestionRespiratory, thoracic and mediastinal disorders50/74934/372
PyrexiaGeneral disorders46/74932/372
RhinorrhoeaRespiratory, thoracic and mediastinal disorders61/74927/372
Oropharyngeal painRespiratory, thoracic and mediastinal disorders59/74928/372
MyalgiaMusculoskeletal and connective tissue disorders25/74927/372

Baseline characteristics

Full Analysis Set

Age, Continuous
Age, Continuous(Years)AZD7442PlaceboTotal
Mean46.62 ± 15.7445.97 ± 16.2046.40 ± 15.89
Age, Customized
Age, Customized(Years)AZD7442PlaceboTotal
Median48.00 (18 to 92)47.00 (18 to 89)48.0 (18 to 92)
Sex: Female, Male
Sex: Female, Male(Participants)AZD7442PlaceboTotal
Female375182557
Male374190564
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AZD7442PlaceboTotal
American Indian or Alaska Native617
Asian151328
Black or African American7636112
Multiple448
Native Hawaiian or Other Pacific Islander213
Not reported15318
Unknown303
White628314942
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AZD7442PlaceboTotal
Hispanic or Latino435210645
Not Hispanic or Latino299159458
Not reported11112
Unknown426
Any COVID-19 comorbidities at baseline
Any COVID-19 comorbidities at baseline(Participants)AZD7442PlaceboTotal
Yes418210628
MISSING331162493
Any high risk for severe COVID-19 at baseline
Any high risk for severe COVID-19 at baseline(Participants)AZD7442PlaceboTotal
Yes486243729
MISSING263129392
SARS-CoV-2 status at baseline
SARS-CoV-2 status at baseline(Participants)AZD7442PlaceboTotal
Negative651327978
Positive341448
MISSING643195

2 further baseline measures are reported on the registry.

08

Study locations

57 sites
  • Research Site
    Guntersville, Alabama 35976, United States
  • Research Site
    Tempe, Arizona 85284, United States
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Bakersfield, California 93309, United States
  • Research Site
    Corona, California 92882, United States
  • Research Site
    Garden Grove, California 92844, United States
  • Research Site
    Huntington Beach, California 92647, United States
  • Research Site
    Huntington Park, California 90255, United States
  • Research Site
    Modesto, California 95350, United States
  • Research Site
    Coral Gables, Florida 33134, United States
  • Research Site
    Coral Springs, Florida 33071, United States
  • Research Site
    Miami Lakes, Florida 33014, United States
  • Research Site
    Miami Lakes, Florida 33016, United States
  • Research Site
    Miami Springs, Florida 33166, United States
  • Research Site
    Miami, Florida 33125, United States
  • Research Site
    Miami, Florida 33155, United States
  • Research Site
    Miami, Florida 33175, United States
  • Research Site
    Miami, Florida 33256, United States
  • Research Site
    Mount Dora, Florida 32757, United States
  • Research Site
    North Miami, Florida 33161, United States
  • Research Site
    Pembroke Pines, Florida 33024, United States
  • Research Site
    Pompano Beach, Florida 33064, United States
  • Research Site
    Tampa, Florida 33603, United States
  • Research Site
    West Palm Beach, Florida 33409, United States
  • Research Site
    Atlanta, Georgia 30328, United States
  • Research Site
    Buford, Georgia 30519, United States
  • Research Site
    Conyers, Georgia 30094, United States
  • Research Site
    Chicago, Illinois 60607, United States
  • Research Site
    Chicago, Illinois 60640, United States
  • Research Site
    Hazel Crest, Illinois 60429-2196, United States
  • Research Site
    Noblesville, Indiana 46060, United States
  • Research Site
    West Des Moines, Iowa 50266, United States
  • Research Site
    Wichita, Kansas 67205, United States
  • Research Site
    Owensboro, Kentucky 42303, United States
  • Research Site
    Bethesda, Maryland 20814, United States
  • Research Site
    High Point, North Carolina 27262, United States
  • Research Site
    Wilmington, North Carolina 28401, United States
  • Research Site
    Orangeburg, South Carolina 29118, United States
  • Research Site
    Dallas, Texas 75235, United States
  • Research Site
    El Paso, Texas 79930, United States
  • Research Site
    Friendswood, Texas 77546, United States
  • Research Site
    Gonzales, Texas 78629, United States
  • Research Site
    Harlingen, Texas 78550, United States
  • Research Site
    Houston, Texas 77099, United States
  • Research Site
    San Antonio, Texas 78215, United States
  • Research Site
    Riverton, Utah 84096, United States
  • Research Site
    Alexandria, Virginia 22311, United States
  • Research Site
    Portsmouth, Virginia 23708, United States
  • Research Site
    Richmond, Virginia 23226, United States
  • Research Site
    Tacoma, Washington 98402, United States
  • Research Site
    Bournemouth, BH7 7DW, United Kingdom
  • Research Site
    Hayle, TR27 5DT, United Kingdom
  • Research Site
    London, EC1A 7BE, United Kingdom
  • Research Site
    London, SE5 8AZ, United Kingdom
  • Research Site
    London, WC1E 6ER, United Kingdom
  • Research Site
    Manchester, M8 5RB, United Kingdom
  • Research Site
    Southampton, SO16 6YD, United Kingdom
09

References and documents

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. Erratum In: Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z. 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 ↗
  • 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 ↗

Study documents

  • Study protocol · Mar 12, 2021
  • Statistical analysis plan · Apr 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04625972
Lead sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd
Responsible party
Sponsor
First posted
Nov 12, 2020
Start date
Dec 2, 2020
Primary completion
Apr 7, 2021
Completion
Jul 25, 2022
Results posted
Oct 25, 2022
Last update
Nov 21, 2023

Study contacts

Myron Levin, MD
principal investigator · AstraZeneca

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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