NOVELLA: 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

Sponsor

AstraZeneca (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06057064

Collaborator

(none)

116

Enrollment

Locations

Arms

8.2

Anticipated Duration (Months)

19.3

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19, SARS-CoV-2	Biological: Biological: AZD3152 Biological: Biological: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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)

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Jun 7, 2024

Anticipated Study Completion Date :

Jun 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Single dose of Placebo IM (0.9% sodium chloride)	Biological: Biological: Placebo Single dose of Placebo IM (0.9% sodium chloride)
Experimental: AZD3152 Single dose of 300 mg IM	Biological: Biological: AZD3152 300 mg single dose of AZD3152 IM

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Single dose of Placebo IM (0.9% sodium chloride)

Biological: Biological: Placebo

Single dose of Placebo IM (0.9% sodium chloride)

Experimental: AZD3152

Single dose of 300 mg IM

Biological: Biological: AZD3152

300 mg single dose of AZD3152 IM

Outcome Measures

Primary Outcome Measures

The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs. [up to Day 181]
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) [up to Day 181]
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 [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).

Other Outcome Measures

The incidence of COVID-19 related hospitalization, and COVID-19 related death [up to 181 Day]
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)
Incidence and percent of subjects with post treatment sero-response for SARS-CoV-2 nucleocapsid antibodies [up to 181 Day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Research Site	Moscow	Russian Federation	115522
2	Research Site	Moscow	Russian Federation	119992
3	Research Site	Moscow	Russian Federation	123182
4	Research Site	Moscow	Russian Federation	125284
5	Research Site	Moscow	Russian Federation	142770
6	Research Site	St Petersburg	Russian Federation	197341

Sponsors and Collaborators

AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT06057064

Other Study ID Numbers:

AZ-RU-00002

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AstraZeneca

Pre-exposure Prophylaxis of COVID-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 28, 2023