| Trial registration number
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DRKS00028865 |
Full text link
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.drks.de/DRKS00028865
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First author
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Heike Windhagen
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Contact
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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hwindhagen@hdz-nrw.de
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Registration date
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-04-26
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Recruitment status
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Men and women after thoracic organ transplantation (heart, lung, combined heart-lung) with a minimum age of 18 years who have received a first and second vaccination against SARS-CoV-2.Precondition: Present signed and dated study consent.
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Exclusion criteria
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Acute infections,Medical complications that could increase the risk of vaccination in the opinion of the clinicians treating the patient and/or the physicians responsible for the study, in particularo Rejection reactions in the past 3 months with the need for augmentation of standard.
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Number of arms
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Herz- und Diabeteszentrum NRW; Klinik für Thorax-und Kardiovaskularchirurgie
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Inclusion age min
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Germany
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Type of patients
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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High risk patients
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Severity scale
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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400
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primary outcome
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Anti-SARS-CoV-2 IgG antibody (Abbott quantitative SARS-CoV-2 antibody assay; traceable to WHO standard) 21-28 days after 3rd vaccination dose
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Notes
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1162, "treatment_name": "Sars-cov-2 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]
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