Maelstrom Research Staging | CKD-COVID19_RCT_group_2_48_hours_to_14_days_postdose

CKD-COVID19_RCT_group_2_48_hours_to_14_days_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

More info

Data Collection Event

CKD-COVID19 - RCT group 2 - 48 hours to 14 days 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).

More info

Collected Dataset / CKD-COVID19_RCT_group_2_48_hours_to_14_days_postdose_3

CKD-COVID19_RCT_group_2_48_hours_to_14_days_postdose_3

Population

CKD-COVID19 - RCT group 2

Data Collection Event

CKD-COVID19 - RCT group 2 - 48 hours to 14 days post-dose 3

Files

Variables Classifications