drugset / Trial / NCT04374539
Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick \<50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
Timeline
- Start
- 2020-04-29
- Primary completion
- 2021-06-06
- Completion
- 2021-06-29
Outcome
Outcome not reported
Stopped (Enrollment): “inability to recruit more patients”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Polyclonal immunoglobulin | Unknown | 100 mg/kg | Intravenous |
| Comparator | Anakinra | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Comparator | Azithromycin | Small molecule | 250 mg | Oral |
| Comparator | Enoxaparin sodium | Other / unclassified | 40 mg | — |
| Comparator | Enoxaparin sodium | Other / unclassified | 60 mg | — |
| Background | Fresh Frozen Plasma | Protein / enzyme biologic | — | — |
| Background | Human Albumin | Protein / enzyme biologic | — | — |
| Comparator | Hydroxychloroquine | Small molecule | 200 mg | — |
| Comparator | Lopinavir | Other / unclassified | — | — |
| Comparator | Methylprednisolone | Other / unclassified | 30 mg | Intravenous |
| Comparator | Ritonavir | Other / unclassified | — | — |
| Comparator | Tocilizumab | Monoclonal antibody | 400 mg | — |
| Comparator | Tocilizumab | Monoclonal antibody | 600 mg | — |