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COVID-19 Antibody Responses in Cystic Fibrosis

Completed
Conditions
Coronavirus disease
COVID-19 infection
10047438
10021605
10010613
Registration Number
NL-OMON56611
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

Consenting people with cystic fibrosis of any age, genotype, transplant status
and disease severity will be eligible to participate in the study.

Exclusion Criteria

There are no specific exclusion criteria other than refusal to give informed
consent, or contraindication to blooddraw.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>• Proportion of people with cystic fibrosis with at least 1 seropositive result<br /><br>over the 2-year period.<br /><br>• Seroprevalence according to age group.<br /><br>• Seroprevalence according to geographical area.<br /><br>• Seroprevalence according to CF disease genotype and severity.<br /><br>• Change in seroprevalence over time.<br /><br>• Risk factors for infection in people with cystic fibrosis.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• Incidence of symptomatic COVID-19 over the 2 year study period and symptom<br /><br>severity.<br /><br>• Proportion of seropositive people with cystic fibrosis with subsequent CF<br /><br>exacerbations compared to people with cystic fibrosis who are<br /><br>seronegative.<br /><br>• Morbidity and mortality in people with cystic fibrosis with at least 1<br /><br>seropositive result compared to people with cystic fibrosis who are<br /><br>seronegative.<br /><br>• Levels and duration of anti-SARS-CoV-2 antibodies in pwCF following natural<br /><br>infection and vaccination SARS-CoV-2.<br /><br>• Optional study objective: analysis of samples could include proteomic and<br /><br>genetic analysis and relating this to clinical outcome and antibody data<br /><br>collected as part of main study.</p><br>
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