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

NCT04374539 | Terminated Phase 2 DMC

• 1 other identifier: 2020-001722-66
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.

Conditions

Coronavirus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plasma exchange

EXPERIMENTAL

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

Biological: Plasma exchange

Standar medical treatment

ACTIVE COMPARATOR

Standar medical treatment

Drug: Standar medical treatmen

Interventions

Plasma exchange BIOLOGICAL

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

Plasma exchange

Standar medical treatmen DRUG

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

Standar medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Model Details: Multicenter open label randomized controlled clinical trial

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: April 29, 2020
• Primary Completion: June 6, 2021
• Study Completion: June 29, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)