Individual Study / CKD-COVID19

Determining the Safety and Efficacy of COVID-19 Vaccination in the Chronic Kidney Disease Population
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Determining the Safety and Efficacy of COVID-19 Vaccination in the Chronic Kidney Disease Population

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Datasets -
Variables -
Start Year
2021
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Investigators Contacts
  • Dr. Michelle Hladunewich
    University of Toronto, Sunnybrook Health Sciences Centre
  • Dr. Adeera Levin
    St. Paul’s Hospital
  • Dr Matthew Oliver
    Sunnybrook Health Sciences Centre Kidney Care Centre at the CNIB Centre
  • Dr. Michelle Hladunewich
    University of Toronto, Sunnybrook Health Sciences Centre
  • Dr. Adeera Levin
    St. Paul’s Hospital

Design

Study design
Other : This study is composed of one cohort study and one clinical trial.
Follow Up
Participants are followed up before and after vaccination.
Supplementary Information
More information on the randomized controlled clinical trial is available at: https://clinicaltrials.gov/ct2/show/NCT05022329

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
Number of Participants with Biological Samples

Access

Availability of data and biosamples

Possible Access to Data
Possible Access to Biosamples
Other
Yes
No
Not applicable
Don't know

Timeline

Populations

Selection Criteria
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status

  • Individuals are prevalent and incident maintenance dialysis patients with chronic kidney disease.

    Individuals are excluded if they receive the Oxford-AstraZeneca vaccine, and if they tested positive for COVID-19 confirmed by reverse transcription-polymerase chain reaction test and their test was reported before December 21, 2020, or within 14 days of study entry. Individuals receiving acute dialysis are also excluded.

Other Criteria
Individuals required a valid Ontario Health Insurance Plan (OHIP) number to permit linking across provincial data sources.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients
Supplementary Information
Individuals were identified using health administration data, including the Ontario Renal Reporting System (ORRS), which is a mandatory reporting system for renal programs in the province of Ontario.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - Dialysis patients ON - Baseline Information from 5 years pre-enrollment was collected from the Ontario Renal Reporting System (ORRS) about age, sex, ethnicity, prior transplants, current dialysis modality, and duration of ... 2021-03
1 CKD-COVID19 - Dialysis patients ON - Unvaccinated follow-up The time prior to vaccination is collected from the Ontario COVAX database. The incidence of SARS-CoV-2 infection is collected from Ontario Laboratories Information System or by regional renal ... 2021-03
2 CKD-COVID19 - Dialysis patients ON - Post-dose 1 follow-up Vaccination data is collected from the Ontario COVAX database. The incidence of SARS-CoV-2 infection is collected from Ontario Laboratories Information System or by regional renal programs to ... 2021-03
3 CKD-COVID19 - Dialysis patients ON - Post-dose 2 follow-up Vaccination data is collected from the Ontario COVAX database. The incidence of SARS-CoV-2 infection is collected from Ontario Laboratories Information System or by regional renal programs to ... 2021-03
Selection Criteria
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status

  • Individuals are prevalent and incident maintenance dialysis patients with chronic kidney disease.

    Individuals are excluded if they receive the Oxford-AstraZeneca vaccine, and if they tested positive for COVID-19 confirmed by reverse transcription-polymerase chain reaction test and their test was reported before December 14, 2020, or within 14 days of study entry. Individuals receiving acute dialysis are also excluded.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients
Supplementary Information
Individuals were identified using the renal-specific information system, Patient Record and Outcomes Management Information System (PROMIS), which captures data on all patients registered in renal programs.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - Dialysis patients BC - Baseline Information was collected from 5 years pre-enrollment through the the Patient Record and Outcomes Management Information System about age, sex, ethnicity, residency, prior transplants, current ... 2021-08
1 CKD-COVID19 - Dialysis patients BC - Unvaccinated follow-up Information is collected from the Patient Record and Outcomes Management Information System about the time prior to vaccination, incidence of SARS-CoV-2 infection, hospitalizations, and death. 2021-08
2 CKD-COVID19 - Dialysis patients BC - Post-dose 1 follow-up Information is collected from the Patient Record and Outcomes Management Information System about vaccinations (which vaccine was administered and the date), incidence of SARS-CoV-2 infection, ... 2021-08
3 CKD-COVID19 - Dialysis patients BC - Post-dose 2 follow-up Information is collected from the Patient Record and Outcomes Management Information System about vaccinations (which vaccine was administered and the date), incidence of SARS-CoV-2 infection, ... 2021-08
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Patients are diagnosed with chronic kidney disease (CKD) stage 3b, 4 or 5, defined as kidney function less than 45 mL/min and received or has agreed to receive a COVID-19 vaccine.
Other Criteria
Patients who have declined or plan to decline the COVID-19 vaccination are excluded from the study.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients
Supplementary Information
Participants will be recruited from participating renal centers.

Number of Participants

Number of Participants
3,000
Number of Participants with Biological Samples
3,000
Supplementary Information about selection criteria

Hemodialysis patients: 1000 participants

Peritoneal dialysis patients: 500 participants

Non dialysis CKD patients: 1500 participants

Data Collection Events
# Name Description Start End
0 CKD-COVID19 - CKD patients - Pre-dose 1 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-03
1 CKD-COVID19 - CKD patients - 1 week post-dose 1 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2021-03
2 CKD-COVID19 - CKD patients - 1 month post-dose 1 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-04
3 CKD-COVID19 - CKD patients - Pre-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-05
4 CKD-COVID19 - CKD patients - 1 week post-dose 2 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2021-05
5 CKD-COVID19 - CKD patients - 1 month post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-06
6 CKD-COVID19 - CKD patients - 3 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-08
7 CKD-COVID19 - CKD patients - 6 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-11
8 CKD-COVID19 - CKD patients - 9 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-01
9 CKD-COVID19 - CKD patients - 12 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-05
10 CKD-COVID19 - CKD patients - Pre-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-08
11 CKD-COVID19 - CKD patients - 1 week post-dose 3 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2021-09
12 CKD-COVID19 - CKD patients - 1 month post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-09
13 CKD-COVID19 - CKD patients - 3 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-11
14 CKD-COVID19 - CKD patients - 6 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-02
15 CKD-COVID19 - CKD patients - 9 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-05
16 CKD-COVID19 - CKD patients - 12 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-08
Selection Criteria
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are in "generally good health" and received or have agreed to receive a COVID-19 vaccine. Participants are excluded if they have chronic health conditions and use immunosuppressive medications, have a history of organ transplantation, chronic kidney disease, diabetes mellitus, hypertension and HIV.
Other Criteria
Participants are healthcare workers.

Recruitment

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - Health care workers - Pre-dose 1 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-03
1 CKD-COVID19 - Health care workers - 1 week post-dose 1 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2021-03
2 CKD-COVID19 - Health care workers - 1 month post-dose 1 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-04
3 CKD-COVID19 - Health care workers - Pre-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-05
4 CKD-COVID19 - Health care workers - 1 week post-dose 2 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2021-05
5 CKD-COVID19 - Health care workers - 1 month post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-06
6 CKD-COVID19 - Health care workers - 3 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-08
7 CKD-COVID19 - Health care workers - 6 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2021-11
8 CKD-COVID19 - Health care workers - 9 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-02
9 CKD-COVID19 - Health care workers - 12 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-05
10 CKD-COVID19 - Health care workers - Pre-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-01
11 CKD-COVID19 - Health care workers - 1 week post-dose 3 Information is collected about adverse events following COVID-19 vaccination such as local reactions at the injection site and symptoms such as fever, chills, fatigue, nausea/vomiting, diarrhea, ... 2022-01
12 CKD-COVID19 - Health care workers - 1 month post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-02
13 CKD-COVID19 - Health care workers - 3 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-04
14 CKD-COVID19 - Health care workers - 6 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-07
15 CKD-COVID19 - Health care workers - 9 months post-dose 2 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2022-10
16 CKD-COVID19 - Health care workers - 12 months post-dose 3 Blood samples are collected. Information about age, sex, ethnicity, residence, income quintile, type of chronic kidney disease, comorbidities, medications, laboratory values, and the history of ... 2023-01
Selection Criteria
Minimum age
18
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
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - RCT group 1 - Pre-dose 1 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 ... 2021-08
1 CKD-COVID19 - RCT group 1 - Pre-dose 2 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 ... 2021-09
2 CKD-COVID19 - RCT group 1 - 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, ... 2021-09
3 CKD-COVID19 - RCT group 1 - 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, ... 2021-10
4 CKD-COVID19 - RCT group 1 - 3 months post-dose 3 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 ... 2021-12
5 CKD-COVID19 - RCT group 1 - 6 months post-dose 3 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 ... 2022-03
6 CKD-COVID19 - RCT group 1 - 9 months post-dose 3 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 ... 2022-06
7 CKD-COVID19 - RCT group 1 - 12 months post-dose 3 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 ... 2022-09
Selection Criteria
Minimum age
18
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
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - RCT group 2 - Pre-dose 1 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 ... 2021-08
1 CKD-COVID19 - RCT group 2 - Pre-dose 2 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 ... 2021-09
2 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, ... 2021-09
3 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, ... 2021-10
4 CKD-COVID19 - RCT group 2 - 3 months post-dose 3 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 ... 2021-12
5 CKD-COVID19 - RCT group 2 - 6 months post-dose 3 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 ... 2022-03
6 CKD-COVID19 - RCT group 2 - 9 months post-dose 3 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 ... 2022-06
7 CKD-COVID19 - RCT group 2 - 12 months post-dose 3 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 ... 2022-09
Selection Criteria
Minimum age
18
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
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - RCT group 3 - Pre-dose 1 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 ... 2021-08
1 CKD-COVID19 - RCT group 3 - Pre-dose 2 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 ... 2021-09
2 CKD-COVID19 - RCT group 3 - 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, ... 2021-09
3 CKD-COVID19 - RCT group 3 - 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, ... 2021-10
4 CKD-COVID19 - RCT group 3 - 3 months post-dose 3 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 ... 2021-12
5 CKD-COVID19 - RCT group 3 - 6 months post-dose 3 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 ... 2022-03
6 CKD-COVID19 - RCT group 3 - 9 months post-dose 3 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 ... 2022-06
7 CKD-COVID19 - RCT group 3 - 12 months post-dose 3 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 ... 2022-09
Selection Criteria
Minimum age
18
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
Data Collection Events
# Name Description Start End
0 CKD-COVID19 - RCT group 4 - Pre-dose 1 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 ... 2021-08
1 CKD-COVID19 - RCT group 4 - Pre-dose 2 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 ... 2021-09
2 CKD-COVID19 - RCT group 4 - 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, ... 2021-09
3 CKD-COVID19 - RCT group 4 - 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, ... 2021-10
4 CKD-COVID19 - RCT group 4 - 3 months post-dose 3 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 ... 2021-12
5 CKD-COVID19 - RCT group 4 - 6 months post-dose 3 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 ... 2022-03
6 CKD-COVID19 - RCT group 4 - 9 months post-dose 3 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 ... 2022-06
7 CKD-COVID19 - RCT group 4 - 12 months post-dose 3 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 ... 2022-09

Classifications

Socio-demographic and economic characteristics
Lifestyle and behaviours
Birth, pregnancy and reproductive health history
Perception of health, quality of life, development and functional limitations
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Life events, life plans, beliefs and values
Preschool, school and work life
Social environment and relationships
Physical environment
Administrative information

Socio-demographic and economic characteristics

Age/birthdate
Sex/gender
Residence
Ethnicity, race and religion

Lifestyle and behaviours

Tobacco

Diseases

Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the musculoskeletal system and connective tissue (M00-M99)
Diseases of the genitourinary system (N00-N99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories

Symptoms and signs

Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving the skin and subcutaneous tissue (R20-R23)
Symptoms and signs involving nervous and musculoskeletal systems (R25-R29)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories

Medication and supplements

Medication and supplement intake

Non-pharmacological interventions

Surgical interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Health and community care services utilization

Hospitalizations
Other health and community care

Death

Vital status
Cause of death
Other end of life or death-related information

Physical measures and assessments

Anthropometry

Laboratory measures

Hematology
Biochemistry
Virology
Immunology

Administrative information

Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Data and sample collection center-related information
Other administrative information