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Clinical Trials/EUCTR2020-005315-44-HU
EUCTR2020-005315-44-HUActive, not recruitingPhase 1

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 - TACKLE

AstraZeneca AB0 sites1,700 target enrollmentStarted: March 2, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
1,700
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 > 0 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 1700
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 1020

Exclusion Criteria

  • •1. History or current hospitalization for COVID-19.
  • •2. Need for hospitalization/immediate medical attention in a clinic/emergency room service
  • •3. Previous 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.
  • •5. 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. Pregnant or breastfeeding women.
  • •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.

Investigators

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EUCTR2020-005315-44-BGAstraZeneca AB1,700