Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial

• Status: Recruiting
• Trial end date: 2021-08-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Criteria

Inclusion Criteria:

1. Male or female subject ≥18 years and < 80 years of age;

2. Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;

3. Subjects admitted in ICU with invasive mechanical ventilation;

4. Informed consent granted via telephone by relatives or legal representative

Exclusion Criteria:

1. More than seven days with invasive mechanical ventilation

2. Refractory Shock (Noradrenaline dose > 0.5 micrograms/ kg/minute)

3. Decompensated Cirrhosis

4. Chronic kidney disease requiring hemodialysis

5. Active neoplastic disease

6. Severe chronic heart failure (NYHA class III or IV)

7. Severe pulmonary disease (GOLD III or IV)

8. HIV infection (AIDS criteria)