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Trial - NCT05022329


Column Value
Trial registration number NCT05022329
Full text link
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05022329

First author
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

Dr. Michelle Hladunewich, MD, FRCPC

Contact
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

Michelle.Hladunewich@sunnybrook.ca

Registration date
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

2021-08-26

Recruitment status
Last imported at : May 8, 2023, midnight
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: patients with chronic kidney disease (ckd)stage 3b-5 defined as an egfr( estimated glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible. stage 5 ckd will include patients receiving in-center hemodialysis, home dialysis (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the covid-19 vaccine will be eligible for a third dose to be given 2-12 months following the second dose. age ≥18 at the time of study enrolment

Exclusion criteria
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov

- patients not vaccinated against covid-19 vaccination. - patients who received heterologous first two doses of vaccine - patients with a severe allergic reaction to prior covid-19 vaccination or any of the ingredients. - new covid-19 infection

Number of arms
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Sunnybrook Health Sciences Centre

Inclusion age min
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 8, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

268

primary outcome
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Serum Level of Anti-RBD ( Anti Receptor Binding Domain )

Notes
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Patients who received two doses Pfizer-BioNTech vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Patients who received two doses MODERNA vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Patients who received two doses Pfizer-BioNTech vaccine", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Patients who received two doses MODERNA vaccine", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]