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

Coronavirus Clinical Trial

— REP-COVID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04374539
• Other study ID #: 2020-001722-66
• Status: Terminated
• Phase: Phase 2
• Start date: April 29, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: March 2022
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: June 29, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Biological:
• Plasma exchange
Plasma exchanges with 5% human albumin and fresh frozen plasma 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. Polyclonal immunoglobulin will be administered at a dose of 100 mg / kg ev after each plasma exchange. Standar Medical treatment Kaletra: lopinavir/ritonavir: 2c/12h 7 days Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV) Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight = 75 Kg) Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days Clexane 40-60 mg/d

Drug:
• Standar medical treatmen
Kaletra: lopinavir/ritonavir: 2c/12h 7 days Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV) Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight = 75 Kg) Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days Clexane 40-60 mg/d

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of plasma exchange	Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.	28 days