Trials / Completed
CompletedNCT04973488
Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Novacescu Alexandru · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.
Detailed description
This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.
Conditions
- COVID-19 Pneumonia
- COVID-19 Respiratory Infection
- Acute Respiratory Failure
- Acute Respiratory Distress Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Therapeutic plasma exchange | The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 |
Timeline
- Start date
- 2020-07-25
- Primary completion
- 2021-01-10
- Completion
- 2021-01-10
- First posted
- 2021-07-22
- Last updated
- 2024-08-26
- Results posted
- 2024-08-26
Locations
1 site across 1 country: Romania
Source: ClinicalTrials.gov record NCT04973488. Inclusion in this directory is not an endorsement.