Trial Outcomes & Findings for Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study (NCT NCT04815850)
NCT ID: NCT04815850
Last Updated: 2024-09-26
Results Overview
Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \>1RLU (relative light units) reported as positive to an upper limit of 10)
COMPLETED
115 participants
1 month post first vaccine
2024-09-26
Participant Flow
Participant milestones
| Measure |
Patients on Haemodialysis
Patients receiving haemodialysis
|
|---|---|
|
Overall Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients on Haemodialysis
n=94 Participants
Patients receiving haemodialysis
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 12.2 • n=94 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=94 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=94 Participants
|
|
Region of Enrollment
United Kingdom
|
94 participants
n=94 Participants
|
PRIMARY outcome
Timeframe: 1 month post first vaccineMeasured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \>1RLU (relative light units) reported as positive to an upper limit of 10)
Outcome measures
| Measure |
Patients on Haemodialysis
n=94 Participants
Patients receiving haemodialysis
|
|---|---|
|
Change in COVID-19 IgG Antibody (Relative Light Units)
|
2.4 relative light unit (RLU)
Standard Error 8.8
|
Adverse Events
Patients on Haemodialysis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place