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Trial - EUCTR2021-000880-63-SE


Column Value
Trial registration number EUCTR2021-000880-63-SE
Full text link
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000880-63/SE

First author
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Skåne University Hospital, department of rheeumatology - Dept of rheumatology Lund/Malmö

Contact
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

meliha.c_kapetanovic@med.lu.se

Registration date
Last imported at : Oct. 11, 2024, 8 a.m.
Source : EU Clinical Trials Register

2021-02-23

Recruitment status
Last imported at : Feb. 21, 2023, noon
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

-age>18 years -having regularly follow up at any of participating rheumatology centra -receiving immunomodulating treatment above for at least 3 months ( only for patients)

Exclusion criteria
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

-receiving immunomodulating treatment for other conditions than rheumatic disease -pregnancy -changes of immunomodulating treatment four weeks before the vaccination -not willing to get vaccinated against COVID19 -ongoing COVID19 or other infection

Number of arms
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

1

Funding
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Skåne University Hospital, department of rheumatology in Lud and Malmö

Inclusion age min
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Sweden

Type of patients
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

High risk patients

Severity scale
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

868

primary outcome
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

The percentage of individuals in each treatment group reaching seroconversion i.e. 4-fold increase in anti-spike IgG and controls 2-6 weeks following vaccination,

Notes
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Declared number of arm (14.0) differs from found arms (3.0)

Phase
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : March 30, 2021, 7:20 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]