Trial · NCT04625725
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
NCT04625725, Phase 3, Completed, AstraZeneca; results first posted 2022-12-20
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. Trials, record NCT04625725. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04625725
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
- NCT number
- NCT04625725
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,197 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COVID-19
- Interventions
- AZD7442, Placebo
- First posted
- 2020-11-12
- Last updated
- 2024-12-31
- Other registries' IDs
- eudract:2020-004356-16
- Results first posted
- 2022-12-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 |
| 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. | 366 days | To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | Incidence of ADA to AZD7442 in Serum | 457 days | To evaluate ADA responses to AZD7442 in serum |
| Other | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | 165 Days | All participants dosed | Participants | COUNT_OF_PARTICIPANTS |
| 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. | 366 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP | 366 Days | All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP | 366 days | All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum AZD7442 Concentrations, PK Parameters if Data Permit. | 457 days | PK analysis set (only AZD7442 arm) | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Incidence of ADA to AZD7442 in Serum | 457 days | AZD7442 ADA Evaluable Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | AEs, SAEs, MAAEs, and AESIs Post Dose of IMP | 457 Days, Final analysis | All participants dosed | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | AZD7442 | Primary Analysis | 8 | Participants | |
| Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Placebo | Primary Analysis | 17 | Participants | |
| Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | AZD7442 | Final Analysis | 12 | Participants | |
| Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness | Placebo | Final Analysis | 34 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | AZD7442 | Adverse Events | 1221 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Placebo | Adverse Events | 593 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | AZD7442 | Serious Adverse Events | 50 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Placebo | Serious Adverse Events | 23 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | AZD7442 | Medically Attended Adverse Events | 360 | Participants | |
| AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis | Placebo | Medically Attended Adverse Events | 157 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Provent Main Study | STARTED | AZD7442 | 3,460 | |
| Provent Main Study | STARTED | Placebo | 1,737 | |
| Provent Main Study | STARTED | Group1 | 0 | |
| Provent Main Study | STARTED | Group 2 | 0 | |
| Provent Main Study | STARTED | Group 3a | 0 | |
| Provent Main Study | STARTED | Group 3b | 0 | |
| Provent Main Study | COMPLETED | AZD7442 | 2,490 | |
| Provent Main Study | COMPLETED | Placebo | 1,179 | |
| Provent Main Study | COMPLETED | Group1 | 0 | |
| Provent Main Study | COMPLETED | Group 2 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events10,758
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | AZD7442 | 0 | 3,461 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 1,736 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Group 1 | 0 | 234 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Group 2 | 1 | 119 | 1 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Group 3a | 0 | 76 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Group 3b | 0 | 74 | 0 |
| other | Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | AZD7442 | 1 | 3,461 | 1 |
| other | Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | Placebo | 0 | 1,736 | 0 |
| other | Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | Group 1 | 0 | 234 | 0 |
| other | Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | Group 2 | 0 | 119 | 0 |
1 to 10 of 10,758Source ClinicalTrials.gov
See all 10,758 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD7442 | 22 | 3,461 |
| Total, all-cause mortality | Placebo | 10 | 1,736 |
| Total, all-cause mortality | Group 1 | 8 | 234 |
| Total, all-cause mortality | Group 2 | 5 | 119 |
| Total, all-cause mortality | Group 3a | 0 | 76 |
| Total, all-cause mortality | Group 3b | 1 | 74 |
| Total, other adverse events | AZD7442 | 1,988 | 3,461 |
| Total, other adverse events | Placebo | 993 | 1,736 |
| Total, other adverse events | Group 1 | 185 | 234 |
| Total, other adverse events | Group 2 | 94 | 119 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers20
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AZD7442 vs Placebo: The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP | Trial comparisons |
| AZD7442 vs Placebo: Incidence of ADA to AZD7442 in Serum | Trial comparisons |
| AZD7442 vs 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. | Trial comparisons |
| AZD7442 vs Placebo: The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04625725
GET https://conductscience.org/api/trials/v1/NCT04625725/results?page=2