Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation

Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation: a randomized study - REP-COVID

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001722-66-ES

Enrollment

116

Registered

2020-04-27

Start date

2020-04-23

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronavirus (covid-19) infection with respiratory failure requiring mechanical ventilation. MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10067221 Term: Mechanical ventilation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Albutein 5% solutión for infusion Product Name: Human Albumin Product Code: B05AA01 Pharmaceutical Form: Solution for infusion INN or Proposed INN: HUMAN SERUM ALBUMIN Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1-Age 18-79 years; 2-Diagnosis of COVID-19 by PCR in nasopharyngeal, sputum or bronchial aspirate smears : 3-Admission to ICU with invasive mechanical ventilation; 4-Telephone informed consent granted by family members or legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1-> 7 days of invasive mechanical ventilation, 2- Refractory shock (norepinephrine> 0.5 microg / Kg / min), 3- Decompensated liver cirrhosis 4- Chronic hemodialysis 5- Active neoplastic disease 6- Moderate or severe heart failure (NYHA III- IV), 7- Moderate-severe lung disease (GOLD III-IV), 8- HIV with AIDS criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of plasma exchange on mortality at 28 days in patients with covid-19 disease and invasive mechanical ventilation.;Secondary Objective: 1– Evaluate survival variables 2– Time in which mechanical ventilation, vasoactive support and renal support have been necessary. 3- Days of ICU stay, days of hospitalization. 4- Evaluation of the degree of organic failure (s) by daily calculation of SOFA and APACHE score during the intervention period (from day 1 to day 7), at discharge from the ICU and from the hospital. 5- Measure the basic systemic inflammatory response. 6- Measure the inflammatory response of advanced inflammatory serum mediators. 7. Evaluate which blood components and molecular pathways are altered and the impact of plasma turnover. 8- Safety variables and adverse events related or not to treatment during its administration period.;Primary end point(s): Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.;Timepoint(s) of evaluation of this end point: Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.	—

Measure

Time frame

Main Objective: To assess the impact of plasma exchange on mortality at 28 days in patients with covid-19 disease and invasive mechanical ventilation.;Secondary Objective: 1– Evaluate survival variables 2– Time in which mechanical ventilation, vasoactive support and renal support have been necessary. 3- Days of ICU stay, days of hospitalization. 4- Evaluation of the degree of organic failure (s) by daily calculation of SOFA and APACHE score during the intervention period (from day 1 to day 7), at discharge from the ICU and from the hospital. 5- Measure the basic systemic inflammatory response. 6- Measure the inflammatory response of advanced inflammatory serum mediators. 7. Evaluate which blood components and molecular pathways are altered and the impact of plasma turnover. 8- Safety variables and adverse events related or not to treatment during its administration period.;Primary end point(s): Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.;Timepoint(s) of evaluation of this end point: Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.

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Secondary

Measure	Time frame
Secondary end point(s): 1- Survival variables: rate and probability of survival in the ICU, in the hospital and at 90 days. 2- Days of mechanical ventilation, rate and days of vasoactive support and renal support. 3-Days of ICU stay, days of hospitalization. 4- Evolution of SOFA and APACHE score during the intervention period (from day 1 to day 7), at the time of ICU discharge. 5- Basic systemic inflammatory response: count of leukocytes and lymphocytes in peripheral blood, serum levels of PCR, procalcitonin, serum parameters of macrophage activation and microangiopathy (LDH, triglycerides, ferritin, D-dimer) at inclusion, daily during the period of intervention (from day 1 to day 7) and discharge from the ICU. 6- Advanced serum inflammatory mediators at inclusion, day 3 and day 7 (10 ml of blood = 30 ml): EGF, eotaxin, TGF-2, FGF-alpha, G-CSF, Fit-3L, GM-CSF, Fractalkine, IFNa2, IFN?, GRO?, IL-10, MCP-3, IL-12P40, MDC, IL-12P70, IL-13, IL-15, sCD40L, IL-17, IL-1RA, IL-1a, IL-9 , IL-1ß, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IP-10, MCP-1, MIP-1a, MIP-1ß, TNFa , TNFß, VEGF, sICAM-1, sVCAM-1, tPAI-1, MIF (Milliplex MAP Human Cytokine / Chemokine Magnetic Bead Panel; Merck Millipore, Darmstadt, Germany; Luminex Corp., Austin, TX). 7- Whole blood for RNA sequencing at inclusion, day 3 and day 7 (6ml x3 = 18 ml; tempus tubes; Applied biosystems, Ambion). 8- plasma samples extracted the first 15 minutes of each refill (10ml x4 = 40ml 9- Safety variables: percentage of plasma changes associated with, at least one adverse event, related to the procedure or not.;Timepoint(s) of evaluation of this end point: 1- rate and probability of survival in the ICU, at 28 and 90 days. 2- Days of mechanical ventilation, frequency and days of vasoactive support and renal support. 3 days of being in the ICU, days of hospitalization. 4- Evolution of the SOFA and APACHE score (day 1 to day 7), discharge from the ICU and hospital. 5- Basic systemic inflammatory response: inclusion, da	—

Measure

Time frame

Secondary end point(s): 1- Survival variables: rate and probability of survival in the ICU, in the hospital and at 90 days. 2- Days of mechanical ventilation, rate and days of vasoactive support and renal support. 3-Days of ICU stay, days of hospitalization. 4- Evolution of SOFA and APACHE score during the intervention period (from day 1 to day 7), at the time of ICU discharge. 5- Basic systemic inflammatory response: count of leukocytes and lymphocytes in peripheral blood, serum levels of PCR, procalcitonin, serum parameters of macrophage activation and microangiopathy (LDH, triglycerides, ferritin, D-dimer) at inclusion, daily during the period of intervention (from day 1 to day 7) and discharge from the ICU. 6- Advanced serum inflammatory mediators at inclusion, day 3 and day 7 (10 ml of blood = 30 ml): EGF, eotaxin, TGF-2, FGF-alpha, G-CSF, Fit-3L, GM-CSF, Fractalkine, IFNa2, IFN?, GRO?, IL-10, MCP-3, IL-12P40, MDC, IL-12P70, IL-13, IL-15, sCD40L, IL-17, IL-1RA, IL-1a, IL-9 , IL-1ß, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IP-10, MCP-1, MIP-1a, MIP-1ß, TNFa , TNFß, VEGF, sICAM-1, sVCAM-1, tPAI-1, MIF (Milliplex MAP Human Cytokine / Chemokine Magnetic Bead Panel; Merck Millipore, Darmstadt, Germany; Luminex Corp., Austin, TX). 7- Whole blood for RNA sequencing at inclusion, day 3 and day 7 (6ml x3 = 18 ml; tempus tubes; Applied biosystems, Ambion). 8- plasma samples extracted the first 15 minutes of each refill (10ml x4 = 40ml 9- Safety variables: percentage of plasma changes associated with, at least one adverse event, related to the procedure or not.;Timepoint(s) of evaluation of this end point: 1- rate and probability of survival in the ICU, at 28 and 90 days. 2- Days of mechanical ventilation, frequency and days of vasoactive support and renal support. 3 days of being in the ICU, days of hospitalization. 4- Evolution of the SOFA and APACHE score (day 1 to day 7), discharge from the ICU and hospital. 5- Basic systemic inflammatory response: inclusion, da

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Countries

Spain

Contacts

Public ContactCTU

Clinical Trial Unit

acruceta@clinic.cat00349322754004380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026