Serum Amyloid A as a prognostic marker for disease severity and mortality in COVID-19

Completed

• Conditions: corona; COVID-19; SAR-COV-2; 10047438

• Registration Number: NL-OMON51218
• Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-31
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

18 years of age or older;
admitted to the COVID-19 cohort ward of the Franciscus Gasthuis &
Vlietland hospital for (suspicion of) SARS-CoV-2 infection;
written informed consent.

Exclusion Criteria

undergoing experimental interventions for COVID-19;

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1 (first 150 subjects):<br /><br>Difference in sensitivity of blood plasma SAA, CRP, ferritin and PCT levels on<br /><br>day 1, day 3, day 5 and day 7 of hospital stay in patients with severe versus<br /><br>non-severe COVID-19 disease course. The sensitivity of SAA will be compared to<br /><br>that of each parameter (CRP, ferritin, PCT) separately.<br /><br><br /><br>Part 2 (after interim analysis and sample size calculation):<br /><br>Difference in sensitivity of blood plasma SAA and the parameter with the<br /><br>highest prognostic ability (determined in part 1 of the study) on the day with<br /><br>the highest prognostic ability (determined in part 1 of the study) of hospital<br /><br>stay in patients with severe versus non-severe COVID-19 disease course. The<br /><br>main study endpoint of part 2 depends on the outcome of the interim analyses. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sensitivity, specificity, positive and negative predictive values, positive and<br /><br>negative likelihood ratios SAA versus CRP, ferritin and PCT.</p><br>