Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
None listed
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Apparently healthy population with no underlying diseases with age � 18 years. 2. Vaccinated or have intent to vaccinate with Cov-ishield according to standard protocol. 1.Age � 18 years with Chronic Kidney disease not on dialysis 2. Vaccinated or have intent to vaccinate with Cov-ishield according to standard protocol.
Exclusion criteria
Exclusion criteria: 1. Chronic kidney disease patients who are recipi-ents of kidney transplant 2. Chronic kidney disease patients with chronic use or high dose steroids or immunosuppresants during the study period. 3. Previous known Covid 19 illness. 4. People with cocommitant co-morbidities such as autoimmune diseases, liver cirrhosis,Congestive heart failure, cancer and HIV. 5. Partially vaccinated individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the immunogenicity of Covishield vac-cine in Non-Dialysis Chronic Kidney Disease pa-tients with healthy subjects by measuring the IgG levels against spike protein in response to Covishield vaccineTimepoint: between 21 to 28 days post vaccination, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the immunogenicity of Covishield vac-cine in non-dialysis Chronic kidney disease patients with healthy subjects by measuring the IFN gamma levels in response to Covishield vaccine between 21 to 28 days post vaccination. To compare the incidence of clinically confirmed Covid illness within three months post vaccination in non-dialysis Chronic Kidney Disease patients with that of the healthy subjects. To compare the safety of Covishield vaccine be-tween the two groups by documenting the adverse reactions post vaccination with AEFI form as report-ed by the study participant To evaluate the safety of Covishield vaccine in non-dialysis Chronic Kidney disease patients by compar-ison of baseline hematological and biochemical pa-rameters such as CBC, UA , RFT ,LFT with that of post vaccination hematological and biochemical pa-rameters To compare the post vaccination hematological and biochemical parameters of non-dialysis CKD patients with that of healthy subjects. Timepoint: between 21 to 28 days post vaccination, 3 months | — |
Countries
India
Contacts
Public ContactDrVinusha Vijayakumar
JIPMER, PUDUCHERRY
Outcome results
None listed