Status:
COMPLETED
Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
Lead Sponsor:
AstraZeneca
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
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 milli...
Eligibility Criteria
Inclusion
- 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.
- WHO Clinical Progression Scale score \> 1 and \< 4.
- 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.
- 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.
- 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).
- 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).
- Participant must be ≥ 18 years of age, provide informed consent and is able to comply with study requirements/procedures.
- 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.
- Women of childbearing potential must use one highly effective form of birth control.
Exclusion
- History or current hospitalization for COVID-19.
- Current need for hospitalization/immediate medical attention in a clinic/emergency room service
- Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
- 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.
- Current requirement or anticipated impending need for mechanical ventilation.
- Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
- Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
- 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.
- 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.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT04723394
Start Date
January 28 2021
End Date
October 19 2022
Last Update
July 5 2023
Active Locations (103)
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1
Research Site
Jasper, Alabama, United States, 35501
2
Research Site
Tucson, Arizona, United States, 85704
3
Research Site
Long Beach, California, United States, 90806
4
Research Site
Northridge, California, United States, 91324