Maelstrom Research Staging | CKD-COVID19_RCT_group_2_1_month_postdose

CKD-COVID19_RCT_group_2_1_month_postdose_3

Networks -

Variables -

Associated study CKD-COVID19 Contingency Table

Population

CKD-COVID19 - RCT group 2

The population is composed of patients in Ontario at least 18 years old with stage 3b-5 or end stage chronic kidney disease (CKD). Participants are part of a four-arm parallel-group randomized control trial (RCT) of Pfizer-BioNTech versus MODERNA COVID-19 vaccine. This population recieves two doses of the MODERNA vaccine and the Pfizer-BioNTech vaccine for the third dose.

Selection Criteria

Minimum age

Newborns

Twins

Countries

Canada

Territory

Ethnic Origin

Health Status

Participants are 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. Patients with stage 5 CKD are included if they are receiving in-center hemodialysis or home dialysis (home hemodialysis or peritoneal dialysis). Participants must get vaccinated with the first two doses of the same COVID-19 vaccine (Pfizer-BioNTech or MODERNA) as determined by their group.

Participants are excluded if they have a severe allergic reaction to prior COVID-19 vaccination or any of the ingredients and if they become infected with COVID-19 following study enrolment (as determined by the blood samples collected at enrolment or by a new positive RT-PCR test).

Recruitment

Sources of recruitment

Specific population

Specific Population

Clinic patients

Number of Participants

Number of Participants: 67
Number of Participants with Biological Samples: 67

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Data Collection Event

CKD-COVID19 - RCT group 2 - 1 month post-dose 3

Adverse events related to the third dose of vaccination are collected including local reactions at the injection site and symptoms (fever, chills, fatigue, nausea/vomiting, diarrhea, muscle pain, joint pains and other adverse events). Blood samples are collected. Information is collected about demographics, comorbidities, medications, laboratory values, and the history of clinic visits and hospital admissions from the Ontario Renal Reporting System (ORRS) or supplemented by the medical record where required.

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Collected Dataset / CKD-COVID19_RCT_group_2_1_month_postdose_3

CKD-COVID19_RCT_group_2_1_month_postdose_3

Population

CKD-COVID19 - RCT group 2

Data Collection Event

CKD-COVID19 - RCT group 2 - 1 month post-dose 3

Files

Variables Classifications