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

Study identifier:D8851C00001

ClinicalTrials.gov identifier:NCT04723394

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

COVID-19

Phase

Phase 3

Healthy volunteers

Study drug

AZD7442, Placebo

Sex

All

Actual Enrollment

910

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 28 Jan 2021

Primary Completion Date: 21 Aug 2021

Study Completion Date: 19 Oct 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

Location

Research Site

Connor Downs, United Kingdom, TR27 5DT

Location

Research Site

Leicester, United Kingdom, LE5 4LJ

Location

Research Site

Blackpool, United Kingdom, FY3 7EN

Location

Research Site

Rochdale, United Kingdom, OL11 4AU

Location

Research Site

Mérida, Mexico, 97070

Location

Research Site

Columbus, OH, United States, 43213

Location

Research Site

Long Beach, CA, United States, 90806

Location

Research Site

Tucson, AZ, United States, 85704

Arms	Assigned Interventions
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 Name: 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.

Documents available

Redacted CSP
Download
Redacted SAP
Download
Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

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Redacted CSP

Redacted SAP

Redacted CSR Synopsis

Trial Results Summaries