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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51218

Enrollment

350

Registered

2021-03-08

Start date

2021-05-11

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona COVID-19 SAR-COV-2

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: undergoing experimental interventions for COVID-19;

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios SAA versus CRP, ferritin and PCT.	—

Countries

Netherlands

Outcome results