COVID-19 (Coronavirus Disease 2019) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Cilgavimab
Product Code: AZD1061
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AZD1061
CAS Number: 2420563-99-9
Current Sponsor code: AZD1061
Other descriptive name: m
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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 or expected administration immediately after enrollment. 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. 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. 9. Currently pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29. 2. Evaluate safety and tolerability of a single IM dose of AZD7442 compared to placebo.;Secondary Objective: Efficacy of AZD7442 in the prevention of the composite endpoint of either death or hospitalization for COVID-19 complications or sequelae through Day 169.;Primary end point(s): 1. A composite of either severe COVID-19 or death from any cause through Day 29. 2. AEs, SAEs, and AESIs through end of study.;Timepoint(s) of evaluation of this end point: 1. Day 29 2. End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A composite of either death from any cause or hospitalization for COVID-19 complications or sequelae during the 168-day post-dose period (Day 1 to Day 169).;Timepoint(s) of evaluation of this end point: Day 1 to Day 169 | — |
Countries
Argentina, Brazil, Bulgaria, Czechia, Germany, Hungary, Italy, Japan, Mexico, Peru, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca AB
Outcome results
None listed