Official Title
A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)
Brief Summary

AZD3152, a single mAb, is being developed to have broad neutralizing activity acrossknown 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 andefficacy of AZD3152 for pre exposure prophylaxis of COVID-19

Detailed 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.

Completed
COVID-19, SARS-CoV-2

Biological: Biological: AZD3152

300 mg single dose of AZD3152 IM

Biological: Biological: Placebo

Single dose of Placebo IM (0.9% sodium chloride)

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
Russia
Locations

Research Site
Moscow 524901, Russia

Research Site
Moscow 524901, Russia

Research Site
Moscow 524901, Russia

Research Site
Moscow 524901, Russia

Research Site
Moscow 524901, Russia

Research Site
Saint Petersburg 498817, Russia

Not Provided

NCT Number
Keywords
Pre-exposure Prophylaxis of COVID-19
MeSH Terms
COVID-19