COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002927-39/AT

Medical University of Vienna - Roman Reindl-Schwaighofer

roman.reindl-schwaighofer@meduniwien.ac.at

2021-05-31

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Intervention A: patient has received a kidney transplantation full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening > 18 years of age no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine Substudy A: no SARS-CoV-2 spike protein antibodies four weeks after the third dose Maintenance immunosuppression with mycophenolate or azathioprine Intervention B: Participant has received a kidney transplantation. Participant has received at least two doses of a SARS-CoV-2 vaccine. > 18 years of age. No neutralizing SARS-CoV-2 antibodies at least 4 weeks after the last dose of any SARS-CoV-2 vaccine.

Intervention A: acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding Substudy A: SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL Intervention B: Prior documented infection with SARS-CoV-2. Triple anticoagulation therapy. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s). Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures. Subject is pregnant or breast feeding. Prior receipt of any mAbs against COVID19 (licensed or investigational) ≤30 days before enrolment. Administration of immunoglobulins ≤30 days before enrolment. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.

2

Medical University of Vienna

18

100

Austria

High risk patients

N/A

400

Intervention A: Number of patients presenting a positive humoral immune response (antibody) at 4 weeks after the third vaccination SubstudyA: atients presenting a positive humoral immune response (antibody) at 4 weeks after the fourth vaccination Intervention B: AZD7442 plasma levels over 12 months

Declared number of arm (2.0) differs from found arms (5.0)

Phase 2

[{"arm_notes": "", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]