COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-006960-26/NO

Oslo University Horspital - Rikshospitalet - Anders Åsberg

anders.asberg@ous-hf.no

2022-08-24

Terminated

RCT

Randomized

Parallel

Open label

single-center

Prevention

Kidney transplant recipients on immunosuppressive therapy. Patients with their last SARS-CoV-2 vaccination at least 3 weeks prior to inclusion. Patients with no or impaired humoral immune response (SARS-CoV-2 Spike RBD antibody level <2000 BAU/mL) at least 3 weeks after the last dose of SARS-CoV-2 vaccine. Not participating in therapeutical intervention studies, within the last 30 days. Adult patients (≥18 years).

Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide). Sensitivity or intolerance to any study drug excipients. Acute febrile illness or acute infection. Prior receipt of any monoclonal antibodies or convalescence plasma against COVID19 (licensed or investigational) < 6 months before enrolment. Administration of immunoglobulins ≤90 days before enrolment. Allergic reaction to previous administrations of monoclonal antibodies. Triple anticoagulation therapy. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. Received any vaccination against other infectious diseases within the last four weeks prior to study drug administration. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization. Patients that the doctor considers to be unsuitable due to, for example, mental condition or abuse.

2

Oslo University Hospital - Rikshospitalet

18

100

Norway

High risk patients

N/A

200

AZD 7442 serum concentrations (µg/mL).

Declared number of arm (2.0) differs from found arms (1.0)

Phase 4

[{"arm_notes": null, "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]