A phase I/III study to assess pre-exposure prophylaxis of AZD5156/AZD3152 in immunocompromised individuals
- Conditions
- COVID-19MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2022-002378-95-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3257
Sentinel Safety Cohort Participants (Phase I)
Participants are eligible to be included in the Sentinel Safety Cohort only if all of the following criteria apply:
1.Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol)
2.Age 18 to 55 years at the time of signing the informed consent
3. Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
4.Negative rapid antigen test at Visit 1
5.Weight = 45 kg and = 110 kg at screening
6. Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator.
Main Cohort Participants (Phase III)
Participants are eligible to be included in the Main Cohort only if all of the following criteria apply:
1.Participant must be 12 years of age or older at the time of signing the informed consent.
2. Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. For participants from 12 to < 18 years of age, their parents or legal guardians must give their signed written informed consent, as appropriate, and participants will sign an assent form.
3.Negative rapid antigen test prior to dosing at Visit 1.
4.Weight = 40 kg at screening
5.Participants must satisfy at least 1 of the following risk factors at enrollment:
•Have solid tumor cancer and be on active immunosuppressive treatment
•Have hematologic malignancy
•Transplant participants must satisfy at least one of the following:
o Have had a solid organ transplant within 2 years and / or
o Had a hematopoietic stem cell transplant within 2 years and / or
o Who have chronic graft-versus-host disease
o Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment
•Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie,= 20 mg prednisone or equivalent per day when administered for = 2 weeks], alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg,Bruton’s tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive biologic agents (eg, for rheumatic diseases)
•Received chimeric antigen receptor T cell therapy
•Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
•Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency
• Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
6. Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for wo
Sentinel Safety Cohort Participants (Phase I)
Participants are excluded from the Sentinel Safety Cohort if any of the following criteria apply:
1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention adm and until at least 6 months after study intervention adm (see details in CSP)
2.Known hypersensitivity to any component of the study intervention.
3.Previous hypersensitivity or severe adverse reaction following admof a mAb.
4.Acute (time-limited) or febrile (temperature = 38.0°C illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM inj or venipuncture.
7.Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1
8.Previous receipt of a mAb against SARS-CoV-2
9.Receipt of a COVID-19 vaccine within 3 months prior to Visit 1
10.Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1
11.COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing])
12. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period
of study follow-up, or concurrent participation in another interventional study.
Main Cohort Participants (Phase III)
Participants are excluded from the Main Cohort if any of the following criteria apply:
1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential(see details in CSP)
2.Known hypersensitivity to any component of the study intervention.
3.Previous hypersensitivity or severe adverse reaction following administration of a mAb.
4.Acute (time-limited) or febrile (temperature = 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
7.Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV or SC immunoglobulin 6 months after dosing.
8 Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
9 Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.
10 Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
11 Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
12 COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method