Phase 2
Completed N=116
Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
COVID-19, SARS-CoV-2
Source: ClinicalTrials.gov NCT06057064 ↗
Enrolled (actual)
116
Serious AEs
6.0%
Results posted
Aug 2025
Primary outcomePrimary: The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs. — 45; 17; 5; 2 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs. |
45; 17; 5; 2; 14; 7 | — |
| SECONDARY Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s) |
12.0; 9.8; 67.7; 11.3; 70.9; 12.1 | — |
| SECONDARY Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s) |
5.63; 1.16; 5.84; 1.24; 4.71; 1.33 | — |
| SECONDARY Incidence of a Post-treatment Symptomatic COVID-19 Case |
4; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Weight ≥ 45 kg at Visit 1.
- Participants must satisfy at least 1 of the following risk factors at enrollment:
- Obese, ie, BMI ≥ 30
- Congestive heart failure
- Chronic obstructive pulmonary disease
- Chronic kidney disease
- Intolerant of vaccine
- Immunocompromised state (one of the following risk factors ):
- Have cancer
- Have solid organ transplant or a hematopoietic stem cell transplant
- Are actively taking immunosuppressive medicines
- Received chimeric antigen receptor T-cell therapy
- Within 1 year of receiving B-cell depleting therapies
- Have a moderate or severe primary immunodeficiency
- Medically stable
- WOCBP must not be pregnant or lactating and must use a highly effective method of contraception
Exclusion Criteria
- Known hypersensitivity to any component of the study intervention
- Previous hypersensitivity or severe adverse reaction following administration of a mAb
- Acute or febrile infection prior to dosing
- Has HIV infection
- Receipt of any convalescent COVID-19 plasma treatment, mAb against SARS-CoV-2 , COVID-19 vaccine within 6 months
- COVID-19 antiviral prophylaxis within at least 2 weeks
- COVID-19 case within 6 months
Data sourced from ClinicalTrials.gov (NCT06057064). 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.