Phase 3
Completed N=1,131
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults
COVID-19
Source: ClinicalTrials.gov NCT04625972 ↗
Enrolled (actual)
1,131
Serious AEs
3.2%
Results posted
Oct 2022
Primary outcomePrimary: Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness — 23; 17; 28; 24 Participants — p=0.212
◆ Published Evidence
Highly cited
152citations · ~30 / year
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
Summary
This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.
Linked Publications (4)
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SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
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SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.
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AZD7442 (Tixagevimab/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness |
23; 17; 28; 24 | 0.212 |
| PRIMARY AEs, SAEs, MAAEs, and AESIs Post Dose of IMP |
348; 193; 345; 191; 20; 16 | — |
| SECONDARY The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP |
0; 1; 0; 1 | 0.664 |
| SECONDARY 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 |
173; 98 | 0.163 |
| SECONDARY The Incidence of COVID-19-related Death Occurring After Dosing With IMP |
0; 0 | — |
| SECONDARY The Incidence of All-cause Mortality Occurring After Dosing With IMP |
3; 2 | 0.744 |
| SECONDARY Serum AZD7442 Concentrations, PK Parameters |
10.028; 11.718; 9.420; 7.183; 2.975; 0.696 | — |
| SECONDARY Incidence of ADA to AZD7442 in Serum |
110; 6 | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 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
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04625972) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.