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

Sponsor
Fundacion Clinic per a la Recerca Biomédica (Other)
Overall Status
Terminated
CT.gov ID
NCT04374539
Collaborator
(none)
36
1
2
14
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Plasma exchange
  • Drug: Standar medical treatmen
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multicenter open label randomized controlled clinical trialMulticenter open label randomized controlled clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
Actual Study Start Date :
Apr 29, 2020
Actual Primary Completion Date :
Jun 6, 2021
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Plasma exchange

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

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

Active Comparator: Standar medical treatment

Standar medical treatment

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

Outcome Measures

Primary Outcome Measures

  1. Impact of plasma exchange [28 days]

    Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic i Provincial de Barcelona Barcelona Spain 08036

Sponsors and Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Cruceta, Project Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT04374539
Other Study ID Numbers:
  • 2020-001722-66
First Posted:
May 5, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022