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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Terminated; Phase 2

Conditions: Coronavirus

Treatments: Drug: Standar medical treatmen; Biological: Plasma exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04374539

2020-001722-66

Details and patient eligibility

About

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.

Full 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, with deleterious effects on the function of different organs and systems. The efficacy and safety of PE has been demonstrated in patients with fulminant hepatitis (FH), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. In FH, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. Such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (PAMPs and DAMPs), proinflammatory mediators (cytokines and ROS), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. Several case reports also suggest that PE is an effective rescue therapy in critically ill patients with influenza A (H1N1). However, the efficacy of PE has not been evaluated in critically ill patients with COVID-19 disease.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Plasma exchange

Experimental group

Description:

Plasma exchange with human serum albumin + Polyclonal immunoglobulin + standard medical treatment

Treatment:

Biological: Plasma exchange

Standar medical treatment

Active Comparator group

Description:

Standar medical treatment

Treatment:

Drug: Standar medical treatmen