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Trial - EUCTR2021-000701-24-NL


Column Value
Trial registration number EUCTR2021-000701-24-NL
Full text link
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000701-24/NL

First author
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Erasmus MC - Hugo van der Kuy

Contact
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

h.vanderkuy@erasmusmc.nl

Registration date
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2021-03-22

Recruitment status
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

All HCW who work in the health care facility with at least one confirmed SARS CoV-2 infected patient receiving care and who have symptoms associated with SARS CoV-2. Alle zorgmedewerkers die minstens één bevestigde SARS-CoV-2 geïnfecteerde patiënt verzorgen die symptomen heeft geassocieerd met SARS-CoV-2

Exclusion criteria
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1. HCW younger than 18 2. HCW that are pregnant or have a wish to become pregnant within 6 months 3. All regular contra-indications of the vaccines will be applied 1. Zorgmedewerkers jonger dan 18 jaar 2. Zorgmedewerkers die zwanger zijn of zwanger willen worden binnen 6 maanden 3. Alle reguliere contra-indicaties bij vaccinaties

Number of arms
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

3

Funding
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Erasmus MC

Inclusion age min
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

64

Countries
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Netherlands

Type of patients
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Health workers

Severity scale
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

600

primary outcome
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Detection of immunity against SARS-CoV-2 Antistof respons tegen SARS-CoV-2

Notes
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Dose 2

Phase
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "The comparator receive two identical vaccinations according to the label", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "ChAdOx1 (1st dose)+COVID-19 mRNA vaccine (2nd dose);1+1;heterologouse prime boost", "treatment_id": 1445, "treatment_name": "Chadox1 ncov-19+covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "COVID-19 mRNA vaccine (1st dose)+ChAdOx1 (2nd dose);1+1;heterologouse prime boost", "treatment_id": 1445, "treatment_name": "Chadox1 ncov-19+covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}]