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Trial - EUCTR2021-000905-26-SE


Column Value
Trial registration number EUCTR2021-000905-26-SE
Full text link
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

First author
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Department of Oncology, Uppsala University Hospita - Department of Oncology

Contact
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

gunilla.enblad@igp.uu.se

Registration date
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

2021-03-12

Recruitment status
Last imported at : Feb. 5, 2025, midnight
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Age 18 years or older Treatment for cancer within 6 month with CD20-depleting therapy and/or check-point inhibitors and/or chemotherapy

Exclusion criteria
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Unable to give informed consent Subject is not eligible to receive Covid-19 vaccine according to current reccommendations from the Public Health Agency of Sweden. Subject has a known hypersensitivity to the active substance or to any of the components of the investigational medical product, as specified in the product’s Summary of Product Characteristics, SmPC . Estimated life expectancy of less than three months.

Number of arms
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

3

Funding
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Department of Oncology, Uppsala University Hospita

Inclusion age min
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Sweden

Type of patients
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

High risk patients

Severity scale
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

150

primary outcome
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

SARS-CoV2 specific immunoglobulin responses SARS-CoV2-antigen induced T cell responses

Notes
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

nan

Phase
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : April 1, 2021, 8:13 p.m.
Source : EU Clinical Trials Register

[{"arm_notes": "Comirnaty", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "COVID-19 Vaccine Moderna", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "VaxZevria", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]