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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05780437




Registration number
NCT05780437
Ethics application status
Date submitted
20/03/2023
Date registered
22/03/2023
Date last updated
4/02/2025

Titles & IDs
Public title
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Scientific title
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H4: AZD7442)
Secondary ID [1] 0 0
014/ACTIV-3/H4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AZD7442
Treatment: Other - Placebo
Treatment: Other - Remdesivir

Experimental: AZD7442 plus SOC - * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Placebo comparator: Placebo plus SOC - * Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion


Treatment: Other: AZD7442
AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2.

Treatment: Other: Placebo
Commercially available 0.9% sodium chloride solution

Treatment: Other: Remdesivir
Antiviral agent
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Sustained Recovery
Timepoint [1] 0 0
Through Day 90
Primary outcome [2] 0 0
Number of Participants With an Ordinal Outcome on Day 5
Timepoint [2] 0 0
Status on Day 5
Secondary outcome [1] 0 0
Number of Participants With a Safety Outcome Through Day 5
Timepoint [1] 0 0
Through Day 5
Secondary outcome [2] 0 0
Number of Participants With a Safety Outcome Through Day 28
Timepoint [2] 0 0
Through Day 28
Secondary outcome [3] 0 0
Number of Participants With a Safety Outcome Through Day 90
Timepoint [3] 0 0
Through Day 90
Secondary outcome [4] 0 0
Number of Participants Who Died From All Causes
Timepoint [4] 0 0
Through Day 90

Eligibility
Key inclusion criteria
• Refer to the master protocol (NCT04501978)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Refer to the master protocol (NCT04501978)
* Additional

* Pregnant women
* Nursing mothers
* Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through the entire 18 months of the study
* Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through the entire 18 months of the study.
* In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2023
Sample size
Target
Accrual to date
Final
1455
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Rhode Island
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
Denmark
State/province [32] 0 0
Aalborg
Country [33] 0 0
Denmark
State/province [33] 0 0
Aarhus N
Country [34] 0 0
Denmark
State/province [34] 0 0
Copenhagen Ø
Country [35] 0 0
Denmark
State/province [35] 0 0
Copenhagen
Country [36] 0 0
Denmark
State/province [36] 0 0
Herlev
Country [37] 0 0
Denmark
State/province [37] 0 0
Hillerød
Country [38] 0 0
Denmark
State/province [38] 0 0
Hvidovre
Country [39] 0 0
Denmark
State/province [39] 0 0
Kolding
Country [40] 0 0
Denmark
State/province [40] 0 0
Odense
Country [41] 0 0
Denmark
State/province [41] 0 0
Roskilde
Country [42] 0 0
Greece
State/province [42] 0 0
Evros
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Poland
State/province [44] 0 0
Warsaw
Country [45] 0 0
Singapore
State/province [45] 0 0
Singapore
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Leida
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Switzerland
State/province [49] 0 0
Zurich
Country [50] 0 0
Uganda
State/province [50] 0 0
Entebbe
Country [51] 0 0
Uganda
State/province [51] 0 0
Gulu
Country [52] 0 0
Uganda
State/province [52] 0 0
Kampala
Country [53] 0 0
Uganda
State/province [53] 0 0
Lira
Country [54] 0 0
Uganda
State/province [54] 0 0
Masaka
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Northumbria
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Copenhagen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Medical Research Council
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Kirby Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Washington D.C. Veterans Affairs Medical Center
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Government body
Name [8] 0 0
US Department of Veterans Affairs
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Prevention and Early Treatment of Acute Lung Injury
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Cardiothoracic Surgical Trials Network
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Commercial sector/industry
Name [11] 0 0
AstraZeneca
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
University of Minnesota
Address [12] 0 0
Country [12] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jens Lundgren, Prof.
Address 0 0
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal ACTIV-3-Therapeutics for Inpatients with COVID-19 ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT05780437