Clareo Health | Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Phase II study to assess the safety, neutralizing activity and efficacy of one dose of AZD3152 compared with one dose of placebo in adults with immunocompromised conditions, including comorbidities contributing to weakened immunity, thereby increasing the risk of COVID-19 progression up to severe grade.
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be 18 years of age or older at the time of signing the informed consent.
Weight ≥ 45 kg at Visit 1.
Participants must satisfy at least 1 of the following risk factors at enrollment:
1. Obese, ie, BMI ≥ 30
2. Congestive heart failure
3. Chronic obstructive pulmonary disease
4. Chronic kidney disease
5. Intolerant of vaccine
6. Immunocompromised state (one of the following risk factors ):
1. Have cancer
2. Have solid organ transplant or a hematopoietic stem cell transplant
3. Are actively taking immunosuppressive medicines
4. Received chimeric antigen receptor T-cell therapy
5. Within 1 year of receiving B-cell depleting therapies
6. Have a moderate or severe primary immunodeficiency
Medically stable
WOCBP must not be pregnant or lactating and must use a highly effective method of contraception
You may not be if
Known hypersensitivity to any component of the study intervention
Previous hypersensitivity or severe adverse reaction following administration of a mAb
Acute or febrile infection prior to dosing
Has HIV infection
Receipt of any convalescent COVID-19 plasma treatment, mAb against SARS-CoV-2 , COVID-19 vaccine within 6 months
COVID-19 antiviral prophylaxis within at least 2 weeks
