MedTrace Logo

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

NCT04374539 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-04-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2021-06-06
Completion
2021-06-29

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374539 on ClinicalTrials.gov