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Trial - NCT05047640


Column Value
Trial registration number NCT05047640
Full text link
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05047640

First author
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Giselle Guerra, MD

Contact
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

gguerra@med.miami.edu

Registration date
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

2021-09-17

Recruitment status
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 21, 2021, 5:30 a.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 : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients 18 years of age and older - patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors. - patients with active graft with at least one immunosuppressive medication - completed two doses of bnt162b2 vaccination at least 28 days ago

Exclusion criteria
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

patient with non-active graft any significant side effect with previous covid-19 vaccination within 28 days of bnt162b2 vaccine completion already received more than and equal to three doses of covid-19 vaccination previously received covid-19 vaccine other than bnt162b2 vaccine previously received monoclonal antibody treatment that are specifically directed against the spike protein for severe acute respiratory syndrome (sars) coronavirus 2 (cov)-2 such as mab, bamlanivimab, etesevimab, casirivimab, imdevimab, sotrovimab and/or any combination. thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination) history of capillary leak syndrome adults unable to consent individuals who are not yet adults (younger than 18 year old) vulnerable patients (prisoners) pregnant women

Number of arms
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Giselle Guerra

Inclusion age min
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

58

primary outcome
Last imported at : June 24, 2023, midnight
Source : ClinicalTrials.gov

Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Notes
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Sept. 21, 2021, 5:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "0,3mL;1;IM", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;IM", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]