New antibody shot aims to shield vulnerable patients from COVID-19

NCT ID NCT05648110

Prevention Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental antibody called AZD3152 to see if it can safely prevent COVID-19 in people with weakened immune systems. About 3,882 adults received either the antibody or a placebo/comparator. The goal was to measure how well the antibody neutralizes the virus and prevents symptomatic COVID-19. The trial has completed, and results are pending.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AZD3152 (a monoclonal antibody injection)
What this could lead to: If successful, this could provide a preventive option for people with weakened immune systems who may not respond well to vaccines.
What could go wrong: The trial is completed but results are not yet published. The antibody may not protect against future virus variants, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

3,882 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 130 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Parent study - Sentinel Safety Cohort Participants (Phase I): Parent study - Sentinel Cohort Inclusion Criteria: * Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol). * Age 18 to 55 years at the time of signing the informed consent. * Negative rapid antigen test at Visit 1. * Weight ≥ 45 kg and ≤ 110 kg at screening. Parent study - Sentinel Cohort Exclusion Criteria: * Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. * Known hypersensitivity to any component of the study intervention. * Previous hypersensitivity or severe adverse reaction following administration of a mAb. * Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once. * Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1. * Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. * Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1. * Previous receipt of a mAb against SARS-CoV-2. * Receipt of a COVID-19 vaccine within 3 months prior to Visit 1. * Receipt of a COVID-19 antiviral for prophylaxis within 3 months prior to Visit 1 * COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at home testing\]). * Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study. * Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. * Active infection with hepatitis B or C. * Serum creatinine, AST, or ALT above 1.5 × ULN at screening * History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years. Parent study - Main Cohort Participants (Phase III): Parent study - Main Cohort Inclusion Criteria: * Participant must be 12 years of age or older at the time of signing the informed consent. * Negative rapid antigen test prior to dosing at Visit 1. * Weight ≥ 40 kg at screening. * Participants must satisfy at least 1 of the following risk factors at enrollment: * Have solid tumor cancer and be on active immunosuppressive treatment * Have hematologic malignancy * Transplant participants must satisfy at least one of the following: 1. Have had a solid organ transplant within 2 years and / or 2. Had a hematopoietic stem cell transplant within 2 years and / or 3. Who have chronic graft-versus-host disease 4. Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment * Are actively taking immunosuppressive medicines (eg, are using corticosteroids \[ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks\], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive \[eg, Bruton's tyrosine kinase inhibitors\], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents (eg, for rheumatic diseases) * Received chimeric antigen receptor T cell therapy * Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab) * Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency * Advanced or untreated HIV infection (people with HIV and CD4 cell counts \< 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) * Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent CV event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment. * Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), including those at Illness Visits, based on the assessment of the Investigator. Parent study - Main Cohort Exclusion Criteria: * Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged \> 12 years will be considered to be a woman of childbearing potential. * Known hypersensitivity to any component of the study intervention. * Previous hypersensitivity or severe adverse reaction following administration of a mAb. * Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once. * Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1. * Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. * Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV or SC immunoglobulin 6 months after dosing. * Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1. * Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1. * Receipt of a COVID-19 vaccine within 3 months prior to Visit 1. * Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1. * COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at home testing\]). * Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study except where the participant ceased IMP treatment \>90 days and is in the follow-up period of the study and not expected to receive further IMP). Sub-study - Inclusion Criteria (Phase II): Sub-study - Sentinel Safety Cohort Inclusion Criteria: * Healthy, defined according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the Investigator. * Participants must be 18 to 55 years at the time of signing the informed consent. * Weight ≥ 45 kg and ≤ 110 kg at screening. Sub-study - Full Sub-study Cohort Inclusion Criteria: * Immunocompromised or immunocompetent, including healthy participants, with all degrees of SARS-CoV-2 infection risk, will be enrolled following completion of Sentinel Safety Cohort enrolment. * Participants must be 18 years of age or older at the time of signing the informed consent. * Weight ≥ 40 kg at screening. Sub-study - Sub-study Sentinel Safety Cohort and Full Sub-study Cohort Inclusion Criteria: * Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. * Negative rapid antigen test for SARS-CoV-2 prior to dosing at Visit 1. * Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent cardiovascular event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment. * Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), based on the assessment of the Investigator. Sub-study - Exclusion Criteria (Phase II): Sub-study - Sentinel Safety Cohort Exclusion Criteria: * Active infection with hepatitis B or C. * Serum creatinine, AST, or ALT above 1.5 × ULN at screening. * History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years. Sub-study - Sentinel Safety Cohort and Full Sub-study Cohort Exclusion Criteria: * Receipt of EVUSHELD (AZD7442) within 12 months prior to Visit 1. * Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged \> 12 years will be considered to be a woman of childbearing potential. * Known hypersensitivity to any component of the study intervention. * Previous hypersensitivity or severe adverse reaction following administration of a mAb. * Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once. * Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1. * Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. * Has human immunodeficiency virus infection. * Receipt of IV or SC immunoglobulin or blood products within 6 months prior to Visit 1 and expected to receive IV or SC immunoglobulin or blood products 6 months after dosing. * Receipt of a COVID-19 vaccine within 3 months prior to Visit 1. * Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1. * COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory RT-PCR testing or a rapid antigen test \[including at-home testing\]). * Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study (except where the participant ceased IMP treatment \> 90 days and is in the follow-up period of the study and not expected to receive further IMP).

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19, SARS-CoV-2

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35215, United States
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Mobile, Alabama, 36608, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85206, United States
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Mesa, Arizona, 85210, United States
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Tucson, Arizona, 85712, United States
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Little Rock, Arkansas, 72205, United States
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Colton, California, 92324, United States
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La Mesa, California, 91942, United States
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Long Beach, California, 90815, United States
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Los Angeles, California, 90027, United States
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Modesto, California, 95350, United States
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Sacramento, California, 95817, United States
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Tustin, California, 92780, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80014, United States
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Denver, Colorado, 80209, United States
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Denver, Colorado, 80246, United States
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Fort Collins, Colorado, 80525, United States
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New Haven, Connecticut, 06519, United States
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Washington D.C., District of Columbia, 20007, United States
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Coral Gables, Florida, 33134, United States
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Fleming Island, Florida, 32003, United States
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Fort Myers, Florida, 33912, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32256, United States
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Lake Worth, Florida, 33462, United States
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Largo, Florida, 33777, United States
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Lauderdale Lakes, Florida, 33313, United States
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Leesburg, Florida, 34748, United States
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Medley, Florida, 33166, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33186, United States
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Miami Lakes, Florida, 33014, United States
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Miami Springs, Florida, 33166, United States
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North Miami Beach, Florida, 33162, United States
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Orlando, Florida, 32806, United States
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Ormond Beach, Florida, 32174, United States
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Port Orange, Florida, 32127, United States
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St. Petersburg, Florida, 33713, United States
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Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30342, United States
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Columbus, Georgia, 31904, United States
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Boise, Idaho, 83712, United States
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Burr Ridge, Illinois, 60527, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60640, United States
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Gurnee, Illinois, 60031, United States
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Evansville, Indiana, 47712, United States
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Evansville, Indiana, 47715, United States
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South Bend, Indiana, 46617, United States
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West Des Moines, Iowa, 50266, United States
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Overland Park, Kansas, 66204, United States
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Wichita, Kansas, 67214, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Lexington, Kentucky, 40509, United States
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Lake Charles, Louisiana, 70605, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70119, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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Methuen, Massachusetts, 01844, United States
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Springfield, Massachusetts, 01107, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Farmington Hills, Michigan, 48334, United States
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Grand Rapids, Michigan, 49525, United States
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Novi, Michigan, 48377, United States
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Saint Clair Shores, Michigan, 48081, United States
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Minneapolis, Minnesota, 55446, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63131, United States
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Missoula, Montana, 59808, United States
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Lincoln, Nebraska, 68516, United States
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Las Vegas, Nevada, 89119, United States
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Portsmouth, New Hampshire, 03801, United States
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Hackensack, New Jersey, 07601, United States
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Albuquerque, New Mexico, 87109, United States
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Buffalo, New York, 14202, United States
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Ridgewood, New York, 11385, United States
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Rochester, New York, 14607, United States
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Rochester, New York, 14642, United States
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Charlotte, North Carolina, 28208, United States
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Durham, North Carolina, 27710, United States
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Monroe, North Carolina, 28112, United States
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Morehead City, North Carolina, 28557, United States
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Wilmington, North Carolina, 28403, United States
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Cincinnati, Ohio, 45267, United States
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Westlake, Ohio, 44145, United States
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Allentown, Pennsylvania, 18103, United States
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Duncansville, Pennsylvania, 16635, United States
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Harrisburg, Pennsylvania, 17110, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Providence, Rhode Island, 02903, United States
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Myrtle Beach, South Carolina, 29572, United States
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North Charleston, South Carolina, 29405, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Austin, Texas, 78745, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79925, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77065, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77089, United States
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Kingwood, Texas, 77339, United States
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Mesquite, Texas, 75150, United States
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San Angelo, Texas, 76904, United States
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San Antonio, Texas, 78229, United States
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Shenandoah, Texas, 77384, United States
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Layton, Utah, 84041, United States
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Salt Lake City, Utah, 84115, United States
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Annandale, Virginia, 22003, United States
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Norfolk, Virginia, 23502, United States
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Norfolk, Virginia, 23507, United States
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Olympia, Washington, 98506, United States
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Seattle, Washington, 98109, United States
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Madison, Wisconsin, 53715, United States
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Melbourne, 3000, Australia
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Melbourne, 3004, Australia
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Murdoch, 6150, Australia
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Parkville, 3050, Australia
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Raymond Terrace, 4101, Australia
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Sippy Downs, 4556, Australia
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West Perth, 6005, Australia
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Alken, 3570, Belgium
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Liège, 4000, Belgium
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Aalborg, 9100, Denmark
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Aarhus, 8200, Denmark
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Hvidovre, 2650, Denmark
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Roskilde, 4000, Denmark
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Svendborg, DK-5700, Denmark
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Dijon, 21079, France
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La Roche-sur-Yon, 85925, France
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Lille, 59037, France
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Nantes, 44093, France
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Nîmes, 30029, France
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Paris, 75014, France
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Paris, 75475, France
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Poitiers, 86000, France
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Saint-Etienne, 42055, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Tours, 37000, France
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Cologne, 50924, Germany
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Essen, 45147, Germany
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Hamburg, 20095, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Seberang Jaya, 13700, Malaysia
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Sunway City, 47500, Malaysia
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Krakow, 30-727, Poland
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Skórzewo, 60-185, Poland
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Singapore, 117599, Singapore
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Singapore, 169608, Singapore
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Singapore, 308442, Singapore
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Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 08308, South Korea
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Seoul, 5505, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Madrid, 28040, Spain
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Marbella (Málaga), 29603, Spain
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Mérida, 06800, Spain
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Pozuelo de Alarcón, 28223, Spain
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Valladolid, 47003, Spain
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Vigo, 36312, Spain
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Taichung, 40447, Taiwan
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Taipei, 11490, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 11000, Thailand
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Muang, 50200, Thailand
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Abu Dhabi, 2951, United Arab Emirates
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Abu Dhabi, 34555, United Arab Emirates
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Bristol, BS2 8DX, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Harrow, HA1 3UJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, SE1 7EH, United Kingdom
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London, W1T 7HA, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Oxford, OX3 7LA, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Torpoint, PL11 2TB, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Hanoi, 100000, Vietnam
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Hochiminh City, 700000, Vietnam