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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05324319 |
|
Full text link
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
2022-04-12 |
|
Recruitment status
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: patient has received a kidney transplantation full sars-cov-2 vaccination with mrna vaccine (two doses) at least 4 weeks before screening > 18 years of age no sars-cov-2 spike protein antibodies at least 4 weeks after the second dose of an mrna vaccine |
|
Exclusion criteria
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
acute illness with fever prior documented infection with sars-cov-2 triple anticoagulation therapy subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures subject is pregnant or breast feeding |
|
Number of arms
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Medical University of Vienna |
|
Inclusion age min
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Austria |
|
Type of patients
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
High risk patients |
|
Severity scale
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
200 |
|
primary outcome
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Seroconversion at 4 weeks |
|
Notes
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : April 21, 2022, 1 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "homologous", "treatment_id": 1431, "treatment_name": "Bnt162b2+mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "heterologous", "treatment_id": 2442, "treatment_name": "Ad26covs1+chadox1 sars2", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |