A Phase 2 interventional study of Biological: AZD3152 and Biological: Placebo in COVID-19, SARS-CoV-2, sponsored by AstraZeneca. Completed at 6 sites in Russia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by AstraZeneca · Phase 2, Interventional, and Prevention
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
The aim of the Phase II study is to evaluate the safety, neutralizing activity and efficacy of AZD3152 for pre exposure prophylaxis of COVID-19
Phase II study to assess the safety, neutralizing activity and efficacy of one dose of AZD3152 compared with one dose of placebo in adults with immunocompromised conditions, including comorbidities contributing to weakened immunity, thereby increasing the risk of COVID-19 progression up to severe grade.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 116 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →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.
Participants must satisfy at least 1 of the following risk factors at enrollment:
Immunocompromised state (one of the following risk factors ):
Exclusion Criteria:
Single dose of Placebo IM (0.9% sodium chloride)
Biological: Biological: Placebo
Single dose of 300 mg IM
Biological: Biological: AZD3152
300 mg single dose of AZD3152 IM
Single dose of Placebo IM (0.9% sodium chloride)
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Time frame: up to Day 181
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
GMT of nAbs against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
Time frame: up to Day 181
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
GMFR (from baseline) of nAb titers against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
Time frame: up to Day 181
Incidence of a Post-treatment Symptomatic COVID-19 Case
Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).
Time frame: up to Day 181
\[Not Specified\]
| Milestone | AZD3152 | Placebo |
|---|---|---|
| Started | 87 | 29 |
| Completed | 83 | 28 |
| Not completed | 4 | 1 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
| Participants | AZD3152 | Placebo |
|---|---|---|
| Adverse Events | 45 | 17 |
| Serious Adverse Events | 5 | 2 |
| Medically Attended Adverse Events | 14 | 7 |
| Adverse Events of Special Interest | 0 | 0 |
GMT of nAbs against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
| Titer | AZD3152 | Placebo |
|---|---|---|
| Baseline GMT | 12.0 ± 3.22 | 9.8 ± 2.50 |
| Visit 2. Day 8 GMT | 67.7 ± 2.02 | 11.3 ± 2.76 |
| Visit 3. Day 15 GMT | 70.9 ± 1.96 | 12.1 ± 2.89 |
| Visit 4. Day 29 GMT | 64.3 ± 2.05 | 12.6 ± 2.67 |
| Visit 5. Day 91 GMT | 37.6 ± 2.24 | 9.1 ± 2.25 |
| Visit 6. Day 181 GMT | 22.4 ± 2.71 | 13.4 ± 2.76 |
GMFR (from baseline) of nAb titers against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
| fold rise | AZD3152 | Placebo |
|---|---|---|
| Visit 2. Day 8 GMFRs | 5.63 ± 2.663 | 1.16 ± 1.941 |
| Visit 3. Day 15 GMFRs | 5.84 ± 2.491 | 1.24 ± 2.247 |
| Visit 4. Day 29 GMFRs | 4.71 ± 2.295 | 1.33 ± 2.014 |
| Visit 5. Day 91 GMFRs | 2.81 ± 2.653 | 1.10 ± 1.986 |
| Visit 6. Day 181 GMFRs | 1.71 ± 2.565 | 1.55 ± 2.462 |
Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).
| Participants | AZD3152 | Placebo |
|---|---|---|
| Incidence of a Post-treatment Symptomatic COVID-19 Case | 4 | 2 |
Collected over AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD3152 | 2/87 (2.3%) | 5/87 (5.7%) | 45/87 (51.7%) |
| Placebo | 0/29 (0%) | 2/29 (6.9%) | 17/29 (58.6%) |
| Event | AZD3152 | Placebo |
|---|---|---|
| Radius fractureInjury, poisoning and procedural complications | 0/87 | 1/1 |
| PneumoniaInfections and infestations | 2/87 | 1/29 |
| Necrotising ulcerative gingivostomatitisInfections and infestations | 0/87 | 1/29 |
| BacteriuriaInfections and infestations | 1/87 | 0/29 |
| COVID-19Infections and infestations | 1/87 | 0/29 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/87 | 0/29 |
| Event | AZD3152 | Placebo |
|---|---|---|
| Respiratory tract infectionInfections and infestations | 9/87 | 1/29 |
| Upper respiratory tract infectionInfections and infestations | 3/87 | 3/29 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/87 | 2/29 |
| COVID-19Infections and infestations | 4/87 | 2/29 |
| NasopharyngitisInfections and infestations | 1/87 | 2/29 |
| Radius fractureInjury, poisoning and procedural complications | 0/87 | 2/29 |
| Blood pressure increasedInvestigations | 0/87 | 2/29 |
| NeutropeniaBlood and lymphatic system disorders | 3/87 | 0/29 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/87 | 1/29 |
| DiarrhoeaGastrointestinal disorders | 1/87 | 1/29 |
| Age, Continuous(Years) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Mean | 55.6 ± 12.61 | 58.2 ± 11.78 | 56.2 ± 12.41 |
| Age, Customized(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| >= 18 to <60 years | 52 | 15 | 67 |
| >=60 years | 35 | 14 | 49 |
| Sex: Female, Male(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Female | 44 | 17 | 61 |
| Male | 43 | 12 | 55 |
| Race/Ethnicity, Customized(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 83 | 28 | 111 |
| Missing | 4 | 1 | 5 |
| Race/Ethnicity, Customized(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| White | 86 | 29 | 115 |
| Asian | 1 | 0 | 1 |
| Other | 0 | 0 | 0 |
| Not Reported | 0 | 0 | 0 |
| Previous COVID-19 vaccinations(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Number | 56 | 13 | 69 |
| SARS-CoV-2 status at baseline(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Negative | 87 | 29 | 116 |
| Positive | 0 | 0 | 0 |
| Missing | 0 | 0 | 0 |
| Any COVID-19 comorbidities at baseline(Participants) | AZD3152 | Placebo | Total |
|---|---|---|---|
| Yes | 87 | 29 | 116 |
| Missing | 0 | 0 | 0 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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.Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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