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.

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:

  1. Obese, ie, BMI ≥ 30

  2. Congestive heart failure

  3. Chronic obstructive pulmonary disease

  4. Chronic kidney disease

  5. Intolerant of vaccine

  6. Immunocompromised state (one of the following risk factors ):

     1. Have cancer
     2. Have solid organ transplant or a hematopoietic stem cell transplant
     3. Are actively taking immunosuppressive medicines
     4. Received chimeric antigen receptor T-cell therapy
     5. Within 1 year of receiving B-cell depleting therapies
     6. 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

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.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. All the data will be provided in blinded manner until final unblinded data analysis will be completed. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.