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Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).
A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | Standard of care according to our current in house SOP | |
| Treatment | Experimental | Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic plasmaexchnage | Device | established method to exchange plasma (in order to remove injurious disease mediators, e.g. antibodies) or to replace consumed factors (e.g. vWF cleaving proteases) |
| Measure | Description | Time Frame |
|---|---|---|
| relative ADAMTS13 deficiency | ADAMTS13 / VWF:Ag | day 1 to 7 |
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Inclusion Criteria:
Exclusion Criteria:
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |