Back to resultsStudy 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)
Primary Purpose
COVID-19, SARS-CoV-2
Status
Not yet recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Biological: AZD3152
Biological: Placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19, SARS-CoV-2 focused on measuring Pre-exposure Prophylaxis of COVID-19
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: 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
AZD3152
Arm Description
Single dose of Placebo IM (0.9% sodium chloride)
Single dose of 300 mg IM
Outcomes
Primary Outcome Measures
The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs.
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Secondary Outcome Measures
Geometric mean titer (GMT) and geometric mean fold rise (GMFRs)
NAbs response will be evaluated based on nAbs titer to the SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study
incidence of a post-treatment symptomatic COVID-19 case
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06057064
Brief Title
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
Acronym
NOVELLA
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
Pre-exposure Prophylaxis of COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is 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 adult participants. Approximately 116 participants in Russia will be randomized at up to 10 study sites in a ratio of 3:1 to either AZD3152 or placebo administered IM.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of Placebo IM (0.9% sodium chloride)
Arm Title
AZD3152
Arm Type
Experimental
Arm Description
Single dose of 300 mg IM
Intervention Type
Biological
Intervention Name(s)
Biological: AZD3152
Intervention Description
300 mg single dose of AZD3152 IM
Intervention Type
Biological
Intervention Name(s)
Biological: Placebo
Intervention Description
Single dose of Placebo IM (0.9% sodium chloride)
Primary Outcome Measure Information:
Title
The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs.
Description
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Time Frame
up to Day 181
Secondary Outcome Measure Information:
Title
Geometric mean titer (GMT) and geometric mean fold rise (GMFRs)
Description
NAbs response will be evaluated based on nAbs titer to the SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study
Time Frame
up to Day 181
Title
incidence of a post-treatment symptomatic COVID-19 case
Description
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).
Time Frame
up to Day 181
Other Pre-specified Outcome Measures:
Title
The incidence of COVID-19 related hospitalization, and COVID-19 related death
Description
The number and proportion of subjects diagnosed with COVID-19 with following events:
Composite number of COVID-19 related hospitalization and/or COVID-19 related death (WHO COVID-19 Clinical Progression Scale score ≥ 4)
Number of COVID-19 related hospitalization (separately)
Number of COVID-19 related death (separately)
Time Frame
up to 181 Day
Title
Incidence and percent of subjects with post treatment sero-response for SARS-CoV-2 nucleocapsid antibodies
Description
Occurrence of post-treatment seroresponse (negative at baseline to positive at any time post-baseline up to 6 months) for SARS-CoV-2 nucleocapsid antibodies.
Time Frame
up to 181 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
142770
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
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
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