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 (NOVELLA)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: COVID-19, SARS-CoV-2

Treatments: Biological: Biological: Placebo; Biological: Biological: AZD3152

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057064

AZ-RU-00002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

116 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of Placebo IM (0.9% sodium chloride)

Treatment:

Biological: Biological: Placebo

AZD3152

Experimental group

Description:

Single dose of 300 mg IM

Treatment:

Biological: Biological: AZD3152