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OpenTrials
Completed

NCT Number: NCT06057064

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

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

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Key information

Conditions

COVID-19, SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological: AZD3152

Biological

300 mg single dose of AZD3152 IM

Biological: Placebo

Biological

Single dose of Placebo IM (0.9% sodium chloride)

Primary outcomes

  1. The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.

    Time frame: up to Day 181

    The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data

Secondary outcomes

  1. Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)

    Time frame: up to Day 181

    GMT of nAbs against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)

  2. Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)

    Time frame: up to Day 181

    GMFR (from baseline) of nAb titers against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)

  3. Incidence of a Post-treatment Symptomatic COVID-19 Case

    Time frame: up to Day 181

    Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: NOVELLA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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