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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

NCT06057064

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: COVID-19, SARS-CoV-2

Interventions: Biological: AZD3152, Biological: Placebo

Countries: Russia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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:

  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

Locations (6)

Moscow, Russia
Moscow, Russia
Moscow, Russia
Moscow, Russia
Moscow, Russia
Saint Petersburg, Russia