The goal of this study is to investigate recent claims from Chinese studies that serum amyloid A (SAA) is a superior prognostic inflammatory marker in COVID-19 when compared to CRP, ferritin and PCT on day 1, day 3, day 5 and day 7 of hospital…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1 (first 150 subjects):
Difference in sensitivity of blood plasma SAA, CRP, ferritin and PCT levels on
day 1, day 3, day 5 and day 7 of hospital stay in patients with severe versus
non-severe COVID-19 disease course. The sensitivity of SAA will be compared to
that of each parameter (CRP, ferritin, PCT) separately.
Part 2 (after interim analysis and sample size calculation):
Difference in sensitivity of blood plasma SAA and the parameter with the
highest prognostic ability (determined in part 1 of the study) on the day with
the highest prognostic ability (determined in part 1 of the study) of hospital
stay in patients with severe versus non-severe COVID-19 disease course. The
main study endpoint of part 2 depends on the outcome of the interim analyses.
Secondary outcome
Sensitivity, specificity, positive and negative predictive values, positive and
negative likelihood ratios SAA versus CRP, ferritin and PCT.
Background summary
Despite advances in knowledge of SARS-CoV-2 infection and coronavirus disease
2019 (COVID-19) treatment, mortality numbers are still significant, and the
course of the disease can be clinically markedly heterogeneous. As such, there
is a strong need for prognostic biomarkers early in the disease.
Study objective
The goal of this study is to investigate recent claims from Chinese studies
that serum amyloid A (SAA) is a superior prognostic inflammatory marker in
COVID-19 when compared to CRP, ferritin and PCT on day 1, day 3, day 5 and day
7 of hospital admission.
Research questions:
1. Estimate the prognostic ability of SAA, CRP, ferritin and PCT as single
markers on day 1, day 3, day 5, day 7 to predict a severe course of COVID-19.
2. Estimate the prognostic ability of SAA, CRP, ferritin and PCT as joint
markers on day 1, day 3, day 5, day 7 to predict a severe course of COVID-19.
3. Estimate the prognostic ability of SAA, CRP, ferritin and PCT and patient
and clinical characteristics as joint markers on day 1, day 3, day 5, day 7 to
predict a severe course of COVID-19.
4. Determine the day(s) at which prognostic ability is maximal.
Study design
This is a monocentre, prospective cohort study.
Study burden and risks
Subjects will have a maximum of 3 additional venepunctures during the study. If
a central catheter is present blood will be collected from the catheter and no
venepuncture is needed. At each time point 1 tube of 10ml of blood will be
collected. We estimate the risk and the burden of the subjects as minimal.
Kleiweg 500
Rotterdam 3118 JH
NL
Kleiweg 500
Rotterdam 3118 JH
NL
Listed location countries
Age
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;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76080.100.20 |
| Other | NL9082 |