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

June 30, 2023 updated by: AstraZeneca

A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults

This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe, with over 35 million confirmed cases reported and more than one million associated deaths according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare systems with significant socioeconomic impacts. Effective interventions to prevent or treat COVID-19 remain few in number and clinical experience is limited.

There is an urgent need to rapidly evaluate treatments in the non-hospitalized setting to prevent progression and reduce serious complications of COVID-19, as well as its transmission.

As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease.

AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.

Enrollment of up to approximately 1700 participants is planned.

Study Type

Interventional

Enrollment (Actual)

910

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1039
        • Research Site
      • Buenos Aires, Argentina, B7600FYW
        • Research Site
      • Buenos Aires, Argentina, C1430EGF
        • Research Site
      • Munro, Argentina, B1605FRE
        • Research Site
  • Brazil
      • Blumenau, Brazil, 89030-101
        • Research Site
      • Porto Alegre, Brazil, 90430-001
        • Research Site
      • Ribeirão Preto, Brazil, 14051-140
        • Research Site
      • Sorocaba, Brazil, 18040-425
        • Research Site
      • São Paulo, Brazil, 01228-200
        • Research Site
  • Czechia
      • Hradec Kralove, Czechia, 500 02
        • Research Site
      • Kolin, Czechia, 280 02
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
  • Germany
      • Berlin, Germany, 10439
        • Research Site
      • Berlin, Germany, 10777
        • Research Site
      • Berlin - Friedrichshain, Germany, 10243
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Frankfurt/Main, Germany, 60389
        • Research Site
      • Hamburg, Germany, 20095
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Koblenz, Germany, 56068
        • Research Site
      • Köln, Germany, 50668
        • Research Site
      • Mainz, Germany, 55128
        • Research Site
      • München, Germany, 80336
        • Research Site
      • München-Pasing, Germany, 81241
        • Research Site
  • Hungary
      • Debrecen, Hungary, 4031
        • Research Site
      • Gyöngyös, Hungary, 3200
        • Research Site
  • Italy
      • Guastalla, Italy, 42016
        • Research Site
      • Milano, Italy, 20127
        • Research Site
      • Piacenza, Italy, 29121
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
      • Roma, Italy, 00149
        • Research Site
  • Japan
      • Chiba-shi, Japan, 260-0852
        • Research Site
      • Hachioji-shi, Japan, 193-0998
        • Research Site
      • Iruma-Gun, Japan, 350-0495
        • Research Site
      • Kyoto-shi, Japan, 607-8062
        • Research Site
      • Maebashi-shi, Japan, 371-0811
        • Research Site
      • Narita-shi, Japan, 286-8520
        • Research Site
      • Sendai-shi, Japan, 983-8512
        • Research Site
      • Shinagawa-ku, Japan, 140-8522
        • Research Site
      • Shinagawa-ku, Japan, 142-8666
        • Research Site
      • Shinjuku-ku, Japan, 162-8655
        • Research Site
  • Mexico
      • Chihuahua, Mexico, 31350
        • Research Site
      • Cuauhtemoc, Mexico, 06700
        • Research Site
      • Cuautitlan Izcalli, Mexico, 54750
        • Research Site
      • Ecatepec de Morelos, Mexico, 55450
        • Research Site
      • Guadalajara, Mexico, 44200
        • Research Site
      • Guadalajara, Mexico, 44100
        • Research Site
      • Mazatlán, Mexico, 82110
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Mérida, Mexico, 97070
        • Research Site
      • Tlalpan, Mexico, 14050
        • Research Site
      • Tlalpan, Mexico, 14080
        • Research Site
  • Peru
      • Lima, Peru, 15088
        • Research Site
  • Poland
      • Rzeszów, Poland, 35-326
        • Research Site
      • Wołomin, Poland, 05-200
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 143442
        • Research Site
      • Murmansk, Russian Federation, 183047
        • Research Site
      • Saint-Petersburg, Russian Federation, 196084
        • Research Site
      • Saint-Petersburg, Russian Federation, 199106
        • Research Site
      • Saint-Petersburg, Russian Federation, 199226
        • Research Site
      • Saint-Petersburg, Russian Federation, 192283
        • Research Site
      • Saint-Petersburg, Russian Federation, 197227
        • Research Site
  • Spain
      • Cabra, Spain, 14940
        • Research Site
      • Centelles (Barcelona), Spain, 08540
        • Research Site
      • Girona, Spain, 17005
        • Research Site
      • Madrid, Spain, 28031
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Research Site
      • Ivano-Frankivsk, Ukraine, 78018
        • Research Site
      • Kherson, Ukraine, 73000
        • Research Site
  • United Kingdom
      • Blackpool, United Kingdom, FY3 7EN
        • Research Site
      • Bracknell, United Kingdom, RG12 8WY
        • Research Site
      • Bristol, United Kingdom, BS8 2PU
        • Research Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Research Site
      • Connor Downs, United Kingdom, TR27 5DT
        • Research Site
      • Highgate, United Kingdom, N19 5NF
        • Research Site
      • Leicester, United Kingdom, LE5 4LJ
        • Research Site
      • Preston, United Kingdom, PR2 9HT
        • Research Site
      • Rochdale, United Kingdom, OL11 4AU
        • Research Site
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Research Site
    • California
      • Long Beach, California, United States, 90806
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
    • Florida
      • Cutler Bay, Florida, United States, 33157
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
      • Pompano Beach, Florida, United States, 33064
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Research Site
      • Charlotte, North Carolina, United States, 28208
        • Research Site
      • Statesville, North Carolina, United States, 28625
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Research Site
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Houston, Texas, United States, 77027
        • Research Site
      • Houston, Texas, United States, 77057
        • Research Site
      • Houston, Texas, United States, 77093
        • Research Site
      • Humble, Texas, United States, 77338
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.
  2. WHO Clinical Progression Scale score > 1 and < 4.
  3. Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as the self-reported date of first reported sign/symptom.
  4. One or more of the following signs/symptoms must be present within 24 hours prior to Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or smell.
  5. Oxygenation saturation of ≥ 92% obtained at rest by study staff within 24 hours prior to Day 1 (unless participant regularly receives chronic supplementary oxygen for an underlying lung condition).
  6. Participant agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days after entry into the study (whichever is earliest).
  7. Participant must be ≥ 18 years of age, provide informed consent and is able to comply with study requirements/procedures.
  8. Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 90 days following administration of IMP.
  9. Women of childbearing potential must use one highly effective form of birth control.

Exclusion Criteria:

  1. History or current hospitalization for COVID-19.
  2. Current need for hospitalization/immediate medical attention in a clinic/emergency room service
  3. Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
  4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any time prior to entry into this study or expected administration immediately after enrollment.
  5. Current requirement or anticipated impending need for mechanical ventilation.
  6. Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
  7. Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
  8. Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry, unless a stable dose is used for a chronic condition.
  9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or expected receipt of IMP during the study follow-up period, or concurrent participation in another interventional study.
  10. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD7442
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442.
Drug: AZD7442
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Other Names:
  • Combination of 2 mAbs (AZD8895 and AZD1061)
Placebo Comparator: Placebo
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo.
Drug: Placebo
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29
Time Frame: Baseline (Day 1) and Day 29
Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 < 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.
Baseline (Day 1) and Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169
Time Frame: Baseline (Day 1) and Day 169
Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169
Baseline (Day 1) and Day 169

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

August 21, 2021

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8851C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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