COVID-19 pneumonia
Conditions
Interventions
Methylprednisolone, eventually supplemented by tocilizumab
Sponsors
Zuyderland Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility for immunosuppressive treatment is based on the Zuyderland treatment protocol (named; ‘Standpunt werkwijze behandeling COVID Zuyderland’, due to frequent updates will the most recent version be leading at any time). According to Zuyderland treatment protocol version from 01.04.2020, this means: 1. Detection of diffuse interstitial pneumonia or bilateral infiltrations on chest x-ray or CO-RADS score =4 based on CT-thorax findings 2. Oxygen saturation at rest in ambient air = 94% or tachypnea =30/min. 3. Presence of at least 2 of the following risk factors for CRS a. High ferritin (> 900 ug/L or two times the level at admission within 48 hours) b. High C-reactive protein (> 100 mg/L) c. High D-dimer (> 1500 ug/L)
Exclusion criteria
Exclusion criteria: No specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to clinical improvement: defined as the time from start of immunosuppressive treatment to improvement of at least 2 points on an ordinal scale 1-7 or hospital discharge, whichever comes first. This endpoint is recommended by WHO and used as the primary endpoint in the Lopinavir-Ritonavir trial. (17) The ordinal scale categories are: 1) non-hospitalized, able to resume normal activities; 2) non-hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen therapy; 4) hospitalized, requiring additional oxygen therapy; 5) hospitalized, requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both; 6) hospitalized, requiring ECMO, mechanical ventilation, or both; and 7) death. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. 3- and 6-months functionality by 6 minutes walking test and by a questionnaire on the number of stairs climbed and distance walked 3. 3- and 6-months quality of life by EQ-5D 4. Mortality at 28 days 5. Time to improvement in 1 point in the clinical status scale (see 1) 6. Clinical status as assessed with the 7-category ordinal scale on day 7 (see 1) 7. Clinical status as assessed with the 7-category ordinal scale on day 14 (see 1) 8. Time until invasive ventilation 9. Duration of mechanical ventilation 10. Duration of hospitalization in survivors 11. Time until independence from oxygen therapy 12. Level of O2 support throughout admission 14. Improvement in CT score (CO-RADS) at 5 days 15. Increase in lymphocytes at 5 days 16. Decrease in CRP at 5 days 17. Decrease in ferritin at 5 days 18. Decrease in D-dimers at 5 days 19. Time (in days) from treatment initiation to death 20. Adverse events (of immunosuppressive treatment) 21. Serious adverse events (of immunosuppressive treatment) 22. Premature discontinuation of immunosuppressive treatment | — |
Contacts
Public ContactSofia Ramiro
Zuyderland Medical Center
Outcome results
None listed