Covid High-intensity Immunosuppression in Cytokine release syndrome
- Conditions
- COVID-19 pneumonia
- Registration Number
- NL-OMON20650
- Lead Sponsor
- Zuyderland Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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)
No specific exclusion criteria
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>
- Secondary Outcome Measures
Name Time Method