AZD7442

Generic Name: AZD7442

Drug Type: Biotech

Background: AZD7442 is a combination of SARS-CoV-2 antibodies (AZD8895 + AZD1061) currently undergoing phase I clinical trials for the prevention and treatment of COVID-19. It was developed by AstraZeneca with the goal of conferring at least 6 months of protection against COVID-19 - a significantly longer window of efficacy than that of other vaccines.

Clinical Trials

AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Phase 3

Completed

Conditions: COVID-19

Interventions: Biological: AZD7442
Biological: Placebo
Biological: Remdesivir

First Posted Date: 2023-03-22

Last Posted Date: 2025-02-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 1455

Registration Number: NCT05780437

Locations: 🇺🇸
West Virginia University (Site 301-023), One Medical Center Drive, Morgantown, West Virginia, United States
🇺🇸
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive, Newport Beach, California, United States
🇺🇸
CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street, Corpus Christi, Texas, United States

and more 121 locations

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

Phase 2

Completed

Conditions: COVID-19, SARS-CoV-2

Interventions: Biological: AZD7442 - EVUSHELD™ (Sub-study)
Biological: AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152
Biological: AZD5156 (Parent study Sentinel Safety Cohort)
Biological: Placebo (Parent study Sentinel Safety Cohort)
Biological: EVUSHELD™ (Parent study Main Cohort)
Biological: Placebo (Parent study Main Cohort)
Biological: AZD3152 (Sub-study)
Biological: AZD3152 (Parent study Main Cohort)

First Posted Date: 2022-12-13

Last Posted Date: 2025-03-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 3882

Registration Number: NCT05648110

Locations: 🇻🇳
Research Site, Hochiminh city, Vietnam

A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults

Phase 1

Completed

Conditions: Healthy Volunteer
Coronavirus Disease 2019 (COVID-19)

Interventions: Drug: AZD7442 IM
Drug: AZD7442 IV
Drug: Placebo IM
Drug: Placebo IV

First Posted Date: 2022-06-29

Last Posted Date: 2023-03-31

Lead Sponsor: AstraZeneca

Target Recruit Count: 61

Registration Number: NCT05437289

Locations: 🇨🇳
Research Site, Shanghai, China

A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19

Phase 2

Terminated

Conditions: Coronavirus Disease 2019 (COVID-19)

Interventions: Biological: AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])

First Posted Date: 2022-05-17

Last Posted Date: 2024-10-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 251

Registration Number: NCT05375760

Locations: 🇺🇸
Research Site, Annandale, Virginia, United States

AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics

Phase 1

Completed

Conditions: SARS-CoV-2

Interventions: Drug: AZD7442

First Posted Date: 2022-03-16

Last Posted Date: 2025-04-18

Lead Sponsor: AstraZeneca

Target Recruit Count: 46

Registration Number: NCT05281601

Locations: 🇬🇧
Research Site, Southampton, United Kingdom

A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

Phase 2

Completed

Conditions: Coronavirus Disease 2019 (COVID-19)

Interventions: Drug: 600 mg AZD7442 IV
Drug: 600mg placebo IV

First Posted Date: 2022-01-11

Last Posted Date: 2024-11-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 272

Registration Number: NCT05184062

Locations: 🇨🇳
Research Site, Xuzhou, China

Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants

Phase 1

Completed

Conditions: Corona Virus Disease

Interventions: Biological: AZD7442
Biological: AZD8895 (cell pool material)
Biological: AZD8895 (clonal cell line material)
Biological: AZD1061 (cell pool material)
Biological: AZD1061 (clonal cell line material)

First Posted Date: 2021-12-22

Last Posted Date: 2024-11-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 224

Registration Number: NCT05166421

Locations: 🇺🇸
Research Site, Houston, Texas, United States

Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: Placebo
Drug: AZD7442

First Posted Date: 2021-01-25

Last Posted Date: 2023-07-05

Lead Sponsor: AstraZeneca

Target Recruit Count: 910

Registration Number: NCT04723394

Locations: 🇬🇧
Research Site, Rochdale, United Kingdom

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: AZD7442
Drug: Placebo

First Posted Date: 2020-11-12

Last Posted Date: 2024-12-31

Lead Sponsor: AstraZeneca

Target Recruit Count: 5197

Registration Number: NCT04625725

Locations: 🇬🇧
Research Site, Wakefield, United Kingdom

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: Placebo
Drug: AZD7442

First Posted Date: 2020-11-12

Last Posted Date: 2023-11-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 1131

Registration Number: NCT04625972

Locations: 🇬🇧
Research Site, Southampton, United Kingdom

Drug Development Updates

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