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CoLab-score and viability PCR for SARS-CoV-2: routine blood test algorithm proven by elimination of viable SARS-CoV-2 to identify patients in order to facilitate discharge and/or de-isolation

CoLab-score and viability PCR for SARS-CoV-2: routine blood test algorithm proven by elimination of viable SARS-CoV-2 to identify patients in order to facilitate discharge and/or de-isolation - CoLaIC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52168
Enrollment
90
Registered
2021-06-21
Start date
2021-12-05
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Corona Covid-19

Interventions

None listed

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - All patients admitted to the ICU /dept. of Lung diseases of the hospital with COVID-19 related complaints. - Patients were required to have data on clinical chemistry and hematological parameters to calculate the CoLab-score.

Exclusion criteria

Exclusion criteria: - Patients 10* standard deviation (SD)) in one or more of the Colab-values) o hemolytic blood samples

Design outcomes

Primary

MeasureTime frame
The following parameters will be collected: - PID nr - date of birth (age is not enough, because we need the age at that moment with 2 decimals to run the algorithm) - Gender - Date admission ICU/nursing ward - Date mechanical ventilation/intubation - Date SARS-CoV-2 RT-PCR - Result SARS-CoV-2 RT-PCR - When positive, Ct-value RT-PCR - Date SARS-CoV-2 viability PCR - Result SARS-CoV-2 viability PCR - When positive, Ct-value viability PCR - Date blood test - CRP - Albumin - Bilirubin, total - LDH - Alkaline Phosphatase - GGT - leukocytes - erytrocytes - eosinophilic granulocytes - basophilic granulocytes - Date CoLab linear predictor calculation - result CoLab linear predictor The CoLab linear predictor (outcome), SARS-CoV-2 RT-PCR and viability PCR results. Internal and external verification of the adapted algorithm, to rule out that patients recovering from COVID-19 are infectious.

Secondary

MeasureTime frame
1. What is the development over time of the (adapted) CoLab-score in COVID-19 positive patients in isolation at the ICU/nursing ward of Pulmonary Diseases? 2. After how many days shows the (adapted) CoLab score a normalization in COVID-19 patients in isolation at the ICU/nursing ward? 3. After how many days the SARS-CoV-2 viability-PCR will become negative in comparison with the SARS-CoV-2 RT-PCR? 4. Is the development of the CoLab-score over time associated with the development of multi-organ failure (serial organ failure assessment; SOFA- score) over time in mechanically ventilated COVID-19 patients at the ICU? 5. Is a low CoLab-score over time associated with negative SARS-CoV-2 viability PCR testing in COVID-19 patients? 6. What is the impact (in costs / benefits and stakeholder experiences) of the implementation of the CoLab score in standard practice?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)