Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19, SARS-CoV-2
Keywords: Pre-exposure Prophylaxis of COVID-19
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs.
timeFrame: up to Day 181
Secondary outcomes:
measure: Geometric mean titer (GMT) and geometric mean fold rise (GMFRs)
timeFrame: up to Day 181
measure: incidence of a post-treatment symptomatic COVID-19 case
timeFrame: up to Day 181
Other outcomes:
measure: The incidence of COVID-19 related hospitalization, and COVID-19 related death
timeFrame: up to 181 Day
measure: Incidence and percent of subjects with post treatment sero-response for SARS-CoV-2 nucleocapsid antibodies
timeFrame: up to 181 Day
Locations:
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
Study officials:
References: