Status:
TERMINATED
Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Coronavirus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 mor...
Detailed Description
Plasma exchange (PE) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, wi...
Eligibility Criteria
Inclusion
- Male or female subject ≥18 years and \< 80 years of age;
- Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;
- Subjects admitted in ICU with invasive mechanical ventilation;
- Informed consent granted via telephone by relatives or legal representative
Exclusion
- More than seven days with invasive mechanical ventilation
- Refractory Shock (Noradrenaline dose \> 0.5 micrograms/ kg/minute)
- Decompensated Cirrhosis
- Chronic kidney disease requiring hemodialysis
- Active neoplastic disease
- Severe chronic heart failure (NYHA class III or IV)
- Severe pulmonary disease (GOLD III or IV)
- HIV infection (AIDS criteria)
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04374539
Start Date
April 29 2020
End Date
June 29 2021
Last Update
April 5 2022
Active Locations (1)
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1
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036