COVID-19, SARS-CoV-2Phase 2NOVELLANCT06057064

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

A Phase 2 study testing Biological: AZD3152 in people with COVID-19, SARS-CoV-2, run by AstraZeneca at 6 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: COVID-19, SARS-CoV-2
What is being tested?: Biological: AZD3152
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 6 sitesRussia
Study dates: 29 Sep 2023to 17 May 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 17Show fewer

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Russia6 sites

Research Site
Moscow, 115478
Research Site
Moscow, 115522
Research Site
Moscow, 123182
Research Site
Moscow, 125284
Research Site
Moscow, 142770
Research Site
Saint Petersburg, 197341

Other trials in Russia

About this study

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)

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

Read the 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.

Conditions: COVID-19, SARS-CoV-2
Being tested: Biological: AZD3152, Biological: Placebo
Keywords: Pre-exposure Prophylaxis of COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biological: AZD3152Biological
300 mg single dose of AZD3152 IM
Biological: PlaceboBiological
Single dose of Placebo IM (0.9% sodium chloride)

Study groups in NCT06057064
Study group	Role	What they receive
Placebo	Placebo comparator	Single dose of Placebo IM (0.9% sodium chloride) Receives: Biological: Biological: Placebo
AZD3152	Experimental	Single dose of 300 mg IM Receives: Biological: Biological: AZD3152

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: up to Day 181

Secondary outcomes (3)

Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
GMT of nAbs against SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study (measured in RU local laboratory)
Measured: up to Day 181
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
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)
Measured: up to Day 181
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).
Measured: up to Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202317 May 2024

First posted28 Sep 2023
Study start29 Sep 2023
Primary completion17 May 2024
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19, SARS-CoV-2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06057064
Sponsor's protocol ID: AZ-RU-00002
Acronym: NOVELLA
Status last verified: Aug 2025
First submitted: 26 Sep 2023
Last updated: 15 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19, SARS-CoV-2 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06057064
Acronym / sponsor ID: NOVELLA / AZ-RU-00002
Conditions: COVID-19, SARS-CoV-2
Keywords: Pre-exposure Prophylaxis of COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 29 Sep 2023 (actual)
Primary completion: 17 May 2024 (actual)
Study completion: 17 May 2024 (actual)
First posted: 28 Sep 2023 (actual)
Results: Posted 15 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Placebo	Placebo comparator	Biological: Biological: PlaceboSingle dose of Placebo IM (0.9% sodium chloride)
AZD3152	Experimental	Biological: Biological: AZD3152Single dose of 300 mg IM

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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:
Medically stable
WOCBP must not be pregnant or lactating and must use a highly effective method of contraception

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biological: AZD3152300 mg single dose of AZD3152 IM	Biological	AZD3152
Biological: PlaceboSingle dose of Placebo IM (0.9% sodium chloride)	Biological	Placebo

Primary outcome

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

3 secondary outcomes

Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
Time frame: up to Day 181
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
Time frame: up to Day 181
Incidence of a Post-treatment Symptomatic COVID-19 Case
Time frame: up to Day 181

Results and safety

Results posted to the registry on 15 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD3152	87	83
Placebo	29	28

Primary outcome: The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.

Time frame: up to Day 181. Count of participants. Unit: Participants

Measure	AZD3152 n = 87	Placebo n = 29
Adverse Events	45	17
Serious Adverse Events	5	2
Medically Attended Adverse Events	14	7
Adverse Events of Special Interest	0	0

Population analysed: Safety analysis population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs, MAAE, AESI will be collected from the time of study intervention administration throughout the study, up to and including the last visit, an average of 6 months. SAEs will be recorded from the time of signing of the ICF throughout the study, up to and including the last visit, an average of 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD3152	5 of 87 (5.7%)	45 of 87 (51.7%)	2 of 87
Placebo	2 of 29 (6.9%)	17 of 29 (58.6%)	0 of 29

Limitations and caveats (from the sponsor): \[Not Specified\]

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted CSPLink provided by the sponsor.
Redacted CSR SynopsisLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biological: AZD3152 in people with COVID-19, SARS-CoV-2, run by AstraZeneca at 6 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs. (time frame: up to Day 181). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.