COVID-19
Conditions
Keywords
Pre-exposure Prophylaxis of COVID-19
Brief summary
This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
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 completed and 2 ongoing Phase I studies with AZD7442. -The Provent repeat dose open-label sub-study is initiated to assess the safety, PK and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the Provent study who may benefit from repeat dose of AZD7442.
Interventions
DRUGAZD7442
* Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183. * Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366
DRUGPlacebo
Single dose (× 2IM injections) of saline placebo on parent study Day 1.
Sponsors
Iqvia Pty Ltd
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age at the time of signing the informed consent 2. Can benefit from passive immunization with antibodies 3. Medically stable 4. Negative result from point of care SARS-CoV-2 serology testing at screening 5. Contraceptive used by women of child bearing potential, condom used by men 6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator Sub-study Inclusion criteria which are additional to those in parent study are as follows: * The participant has been randomized, dosed, and is ongoing in the PROVENT parent study and is 12±2 months post first dose of blinded IMP. * If one or more of the following apply: 1. Immunocompromised and/or may be at increased risk for an inadequate immune response to a COVID-19 vaccine. 2. In the opinion of the Investigator, are at increased risk and would benefit from a repeat dose of AZD7442. * Documented negative SARS-CoV-2 RT-PCR test collected ≤ 3 days prior to sub-study Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
Exclusion criteria
1. Significant infection or other acute illness, including fever \>100°F (\>37.8°C) on the day prior to or day of randomization. 2. History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening. 3. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS). 4. Known history of allergy or reaction to any component of the study drug formulation. 5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb. 6. 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. 7. Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture. 8. Any other significant disease, disorder, or finding. that 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. 9. 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 10. Currently pregnant or breastfeeding. 11. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization. 12. 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. 13. 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. Sub-study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | 457 Days, Final analysis | To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo |
| Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | 165 Days for primary analysis, 183 days for final analysis | To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP | 366 Days | To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19 |
| The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP | 366 days | To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits |
| Incidence of ADA to AZD7442 in Serum | 457 days | To evaluate ADA responses to AZD7442 in serum |
| Serum AZD7442 Concentrations, PK Parameters if Data Permit. | 457 days | To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM |
| The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies. | 366 days | To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection |
Other
| Measure | Time frame | Description |
|---|---|---|
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | 165 Days | To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo |
Countries
Belgium, France, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD7442 300 mg (AZD8895 and AZD1061) | 3,460 |
| Placebo Saline Placebo | 1,737 |
| Group 1 2 doses of AZD7442 300mg, 10-14 months schedule | 234 |
| Group 2 2 doses ofAZD7442 300mg, 6 month schedule | 119 |
| Group 3a 2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule | 76 |
| Group 3b 1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule | 74 |
| Total | 5,700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Provent Main Study | Adverse Event | 2 | 1 | 0 | 0 | 0 | 0 |
| Provent Main Study | Death | 22 | 10 | 0 | 0 | 0 | 0 |
| Provent Main Study | INCARCERATION | 3 | 0 | 0 | 0 | 0 | 0 |
| Provent Main Study | Lost to Follow-up | 357 | 200 | 0 | 0 | 0 | 0 |
| Provent Main Study | MISSING REASON | 0 | 1 | 0 | 0 | 0 | 0 |
| Provent Main Study | MOVED ABROAD / LOCATION | 7 | 2 | 0 | 0 | 0 | 0 |
| Provent Main Study | PARTICIPANT COULD NOT BE REACHED PRIOR TO DBL | 14 | 2 | 0 | 0 | 0 | 0 |
| Provent Main Study | PARTICIPANT DID NOT ATTEND VISIT | 2 | 2 | 0 | 0 | 0 | 0 |
| Provent Main Study | PARTICIPANT NOT COMPLIANT | 1 | 1 | 0 | 0 | 0 | 0 |
| Provent Main Study | PARTICIPANT NOT FULFILLING INCLUSION CRITERIA | 1 | 0 | 0 | 0 | 0 | 0 |
| Provent Main Study | Participants dosed in sub-study | 310 | 193 | 0 | 0 | 0 | 0 |
| Provent Main Study | Physician Decision | 5 | 0 | 0 | 0 | 0 | 0 |
| Provent Main Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Provent Main Study | Withdrawal by Subject | 242 | 144 | 0 | 0 | 0 | 0 |
| Provent Main Study | WITHDRAWAL OF CONSENT | 3 | 2 | 0 | 0 | 0 | 0 |
| Provent Sub Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Provent Sub Study | Death | 0 | 0 | 8 | 5 | 0 | 1 |
| Provent Sub Study | DUE TO SUBJECT'S DECLINING HEALTH THE SUBJECT WILL NO LONGER BE ABLE TO PARTICIPATE IN THE STUDY | 0 | 0 | 0 | 0 | 1 | 0 |
| Provent Sub Study | Lost to Follow-up | 0 | 0 | 20 | 10 | 6 | 4 |
| Provent Sub Study | NON COMPLIANCE BY SUBJECT | 0 | 0 | 0 | 0 | 0 | 1 |
| Provent Sub Study | SUBJECT MOVED OUT OF AREA | 0 | 0 | 0 | 1 | 0 | 0 |
| Provent Sub Study | SUBJECT WAS MOVING AWAY FROM THE STUDY CLINIC | 0 | 0 | 1 | 0 | 0 | 0 |
| Provent Sub Study | Withdrawal by Subject | 0 | 0 | 11 | 13 | 5 | 6 |
Baseline characteristics
| Characteristic | AZD7442 | Placebo | Total | Group 2 | Group 3b | Group 1 | Group 3a |
|---|---|---|---|---|---|---|---|
| Age, Continuous Main Study | 57 Years | 57 Years | 57 Years | — | — | — | — |
| Age, Continuous Sub Study | — | — | 62 Years | 62.0 Years | 61 Years | 62.0 Years | 60.5 Years |
| Age, Customized Main Study : >= 18 - < 60 years | 1960 Participants | 980 Participants | 2940 Participants | — | — | — | — |
| Age, Customized Main Study : >= 60 - < 70 years | 1083 Participants | 563 Participants | 1646 Participants | — | — | — | — |
| Age, Customized Main Study : >= 70 - < 80 years | 368 Participants | 174 Participants | 542 Participants | — | — | — | — |
| Age, Customized Main Study : >= 80 years | 49 Participants | 20 Participants | 69 Participants | — | — | — | — |
| Age, Customized Sub Study : >= 18 - < 60 years | — | — | 183 Participants | 37 Participants | 33 Participants | 82 Participants | 31 Participants |
| Age, Customized Sub Study : >= 60 - < 70 years | — | — | 224 Participants | 58 Participants | 30 Participants | 103 Participants | 33 Participants |
| Age, Customized Sub Study : >= 70 - < 80 years | — | — | 83 Participants | 21 Participants | 10 Participants | 44 Participants | 8 Participants |
| Age, Customized Sub Study : >= 80 years | — | — | 13 Participants | 3 Participants | 1 Participants | 5 Participants | 4 Participants |
| Any COVID-19 comorbidities at baseline Main Study Missing | 1028 Participants | 531 Participants | 1559 Participants | — | — | — | — |
| Any COVID-19 comorbidities at baseline Main Study Yes | 2432 Participants | 1206 Participants | 3638 Participants | — | — | — | — |
| Any COVID-19 comorbidities at baseline Sub Study Missing | — | — | 80 Participants | 22 Participants | 6 Participants | 42 Participants | 10 Participants |
| Any COVID-19 comorbidities at baseline Sub Study Yes | — | — | 423 Participants | 97 Participants | 68 Participants | 192 Participants | 66 Participants |
| Any high risk for severe COVID-19 at baseline Main Study Missing | 786 Participants | 371 Participants | 1157 Participants | — | — | — | — |
| Any high risk for severe COVID-19 at baseline Main Study Yes | 2674 Participants | 1366 Participants | 4040 Participants | — | — | — | — |
| Any high risk for severe COVID-19 at baseline Sub Study Missing | — | — | 45 Participants | 12 Participants | 1 Participants | 25 Participants | 7 Participants |
| Any high risk for severe COVID-19 at baseline Sub Study Yes | — | — | 458 Participants | 107 Participants | 73 Participants | 209 Participants | 69 Participants |
| Baseline BMI Main Study | 29.57 kg/m**2 STANDARD_DEVIATION 6.88 | 29.62 kg/m**2 STANDARD_DEVIATION 6.98 | 29.59 kg/m**2 STANDARD_DEVIATION 6.91 | — | — | — | — |
| Baseline BMI Sub Study | — | — | 29.78 kg/m**2 STANDARD_DEVIATION 6.43 | 28.88 kg/m**2 STANDARD_DEVIATION 6.31 | 31.50 kg/m**2 STANDARD_DEVIATION 7.06 | 29.72 kg/m**2 STANDARD_DEVIATION 6 | 29.67 kg/m**2 STANDARD_DEVIATION 7.06 |
| Height Main Study | 170.04 cm STANDARD_DEVIATION 10.1 | 170.17 cm STANDARD_DEVIATION 9.84 | 170.9 cm STANDARD_DEVIATION 10.02 | — | — | — | — |
| Height Sub Study | — | — | 169.97 cm STANDARD_DEVIATION 10.16 | 171.25 cm STANDARD_DEVIATION 10.06 | 168.72 cm STANDARD_DEVIATION 10.27 | 170.03 cm STANDARD_DEVIATION 10.29 | 169.03 cm STANDARD_DEVIATION 9.76 |
| Race/Ethnicity, Customized Main Study American Indian or Alaska Native | 19 Participants | 10 Participants | 29 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Asian | 110 Participants | 60 Participants | 170 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Black or African American | 597 Participants | 302 Participants | 899 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Hispanic or Latino | 539 Participants | 215 Participants | 754 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Missing | 2 Participants | 2 Participants | 4 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Native Hawaiian or Other Pacific Islander | 4 Participants | 4 Participants | 8 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Not Hispanic or Latino | 2731 Participants | 1412 Participants | 4143 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Not reported | 89 Participants | 72 Participants | 188 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Other | 15 Participants | 12 Participants | 27 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study Unknown | 74 Participants | 38 Participants | 121 Participants | — | — | — | — |
| Race/Ethnicity, Customized Main Study White | 2545 Participants | 1249 Participants | 3794 Participants | — | — | — | — |
| Race/Ethnicity, Customized Sub Study American Indian or Alaska Native | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Sub Study Asian | — | — | 12 Participants | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Sub Study Black or African American | — | — | 59 Participants | 11 Participants | 14 Participants | 20 Participants | 14 Participants |
| Race/Ethnicity, Customized Sub Study Hispanic or Latino | — | — | 58 Participants | 6 Participants | 12 Participants | 31 Participants | 9 Participants |
| Race/Ethnicity, Customized Sub Study Missing | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Sub Study Native Hawaiian or Other Pacific Islander | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Sub Study Not Hispanic or Latino | — | — | 418 Participants | 109 Participants | 56 Participants | 192 Participants | 61 Participants |
| Race/Ethnicity, Customized Sub Study Not reported | — | — | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Sub Study Other | — | — | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Sub Study Unknown | — | — | 12 Participants | 1 Participants | 3 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Sub Study White | — | — | 415 Participants | 106 Participants | 53 Participants | 204 Participants | 52 Participants |
| Region Main Study European Union | 362 Participants | 193 Participants | 555 Participants | — | — | — | — |
| Region Main Study North America | 2487 Participants | 1232 Participants | 3719 Participants | — | — | — | — |
| Region Main Study United Kingdom | 611 Participants | 312 Participants | 923 Participants | — | — | — | — |
| Region Sub Study European Union | — | — | 44 Participants | 17 Participants | 0 Participants | 27 Participants | 0 Participants |
| Region Sub Study North America | — | — | 355 Participants | 75 Participants | 74 Participants | 130 Participants | 76 Participants |
| Region Sub Study United Kingdom | — | — | 104 Participants | 27 Participants | 0 Participants | 77 Participants | 0 Participants |
| SARS-CoV-2 status at baseline Main Study Missing | 125 Participants | 66 Participants | 191 Participants | — | — | — | — |
| SARS-CoV-2 status at baseline Main Study Negative | 3316 Participants | 1665 Participants | 4981 Participants | — | — | — | — |
| SARS-CoV-2 status at baseline Main Study Positive | 19 Participants | 6 Participants | 25 Participants | — | — | — | — |
| SARS-CoV-2 status at baseline Sub Study Missing | — | — | 13 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants |
| SARS-CoV-2 status at baseline Sub Study Negative | — | — | 488 Participants | 114 Participants | 70 Participants | 229 Participants | 75 Participants |
| SARS-CoV-2 status at baseline Sub Study Positive | — | — | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Main Study Female | 1594 Participants | 802 Participants | 2396 Participants | — | — | — | — |
| Sex: Female, Male Main Study Male | 1866 Participants | 935 Participants | 2801 Participants | — | — | — | — |
| Sex: Female, Male Sub Study Female | — | — | 229 Participants | 48 Participants | 35 Participants | 113 Participants | 33 Participants |
| Sex: Female, Male Sub Study Male | — | — | 274 Participants | 71 Participants | 39 Participants | 121 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 22 / 3,461 | 10 / 1,736 | 8 / 234 | 5 / 119 | 0 / 76 | 1 / 74 |
| other Total, other adverse events | 1,988 / 3,461 | 993 / 1,736 | 185 / 234 | 94 / 119 | 58 / 76 | 55 / 74 |
| serious Total, serious adverse events | 215 / 3,461 | 97 / 1,736 | 31 / 234 | 20 / 119 | 12 / 76 | 12 / 74 |
Outcome results
Primary
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
Time frame: 457 Days, Final analysis
Population: All participants dosed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Adverse Events | 2016 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Serious Adverse Events | 215 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Medically Attended Adverse Events | 991 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Adverse Events of Special Interest | 103 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Adverse Events of Special Interest | 43 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Adverse Events | 1007 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Medically Attended Adverse Events | 439 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | Serious Adverse Events | 97 Participants |
Primary
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 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.
Time frame: 165 Days for primary analysis, 183 days for final analysis
Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AZD7442 | Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Primary Analysis | 8 Participants |
| AZD7442 | Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Final Analysis | 12 Participants |
| Placebo | Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Primary Analysis | 17 Participants |
| Placebo | Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Final Analysis | 34 Participants |
Comparison: Primary Analysisp-value: <0.00195% CI: [46.05, 89.96]Poisson regression
Comparison: Final Analysisp-value: <0.00195% CI: [67.26, 91.21]Poisson regression
Secondary
Incidence of ADA to AZD7442 in Serum
To evaluate ADA responses to AZD7442 in serum
Time frame: 457 days
Population: AZD7442 ADA Evaluable Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD7442 | Incidence of ADA to AZD7442 in Serum | 403 Participants |
| Placebo | Incidence of ADA to AZD7442 in Serum | 34 Participants |
Secondary
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
Time frame: 457 days
Population: PK analysis set (only AZD7442 arm)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 8 | 18.667 µg/mL | Geometric Coefficient of Variation 92.947 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 29 | 22.602 µg/mL | Geometric Coefficient of Variation 64.691 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 58 | 18.707 µg/mL | Geometric Coefficient of Variation 65.981 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 92 | 14.037 µg/mL | Geometric Coefficient of Variation 67.922 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 183 | 5.593 µg/mL | Geometric Coefficient of Variation 83.58 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 366 | 1.340 µg/mL | Geometric Coefficient of Variation 90.132 |
| AZD7442 | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | Day 457 | 0.565 µg/mL | Geometric Coefficient of Variation 85.733 |
Secondary
The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
Time frame: 366 days
Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD7442 | The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP | 8 Participants |
| Placebo | The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP | 8 Participants |
p-value: 0.13795% CI: [-26.61, 82.13]Poisson regression
Secondary
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
Time frame: 366 days
Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection and had an evaluable sample obtained.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD7442 | The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies. | 198 Participants |
| Placebo | The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies. | 139 Participants |
p-value: <0.00195% CI: [21.44, 46.05]Poisson regression
Secondary
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
Time frame: 366 Days
Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD7442 | The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP | 2 Participants |
| Placebo | The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP | 11 Participants |
p-value: 0.00195% CI: [61.31, 98.09]Poisson regression
Other Pre-specified
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis
To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
Time frame: 165 Days
Population: All participants dosed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Adverse Events | 1221 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Medically Attended Adverse Events | 360 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Serious Adverse Events | 50 Participants |
| AZD7442 | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Adverse Events of Special Interest | 93 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Serious Adverse Events | 23 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Adverse Events | 593 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Adverse Events of Special Interest | 37 Participants |
| Placebo | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Medically Attended Adverse Events | 157 Participants |