Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)

April 23, 2020 updated by: Manuel Castellà

Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)

Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS).

Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Positive revere transcription polymerase chain reaction (RT-PCR) for COVID-19 in a respiratory track sample

  3. Acute (less than 36 hours) onset of moderate to severe ARDS, as defined by Berlin criteria:

    • Having pneumonia or worsening respiratory symptoms
    • Bilateral pulmonary infiltrates on chest imaging (X-ray of CT scan)
    • Pulmonary wedge pressure <18 mmHg or no clinical signs of left heart failure
    • Hypoxemia: arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2 ratio) <200mmHg, moderate dyspnea with signs of important respiratory workload, tachypnoea >30bpm
  4. Rise of inflammatory biomarkers: C-reactive protein (CRP) >10 mg/L

Exclusion Criteria:

  1. Patients with a known contraindication for anticoagulation
  2. Pregnancy or breast feeding
  3. Patient already included in another research study
  4. Decision by a physician that involvement in the study is not in the patient's best interest
  5. Failure to have patient's authorization. In case of a mechanical intubated patient, lack of authorization from a first line family member
  6. Multi-organ failure
  7. Patients treated with Tocilizumab at the time of start filtration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
standard intensive care alone
Experimental: Cytokine Adsorption
cytokine adsorption plus standard intensive care
Device: Cytokine Adsorption
Cytokine adsorption will be performed through a venous hemodialysis catheter, preferably jugular or femoral. The filtration system will be established with a cytokine adsorption cartridge in an hemoperfusion system using a blood flow rate of 150 - 200 ml/min. Adsorbent therapy will last 72 hours, changing cartridges every 24 hours. Prior to start, heparinization will be stablished by a 1mg/Kg iv Na heparin bolus plus iv perfusion. Activated Partial Thromboplastin Time (aPTT) control will be performed every 6 hours, with a goal range between 60 and 80 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation-free days
Time Frame: up to 28days
Number of ventilator-free days (VFDs) at day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment. For patients ventilated 28 days or longer and for ventilated subjects who die, VFD is 0
up to 28days

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day mortality
Time Frame: up to 30 days
up to 30 days
length of ICU stay (days)
Time Frame: up to 30 days
up to 30 days
length of hospital stay
Time Frame: up to 30 days
up to 30 days
Duration of renal replacement and cathecolamines therapies
Time Frame: up to 30 days
up to 30 days
Need for extracorporeal membrane oxygenation (ECMO) support
Time Frame: up to 30 days
up to 30 days
multi-organ failure measured by the Sequential Organ Failure Assessment (SOFA) score
Time Frame: up to 30 days (measured on days 0, 1, 2, 3, 4, 5, 6, and the last day of mechanical ventilation)
up to 30 days (measured on days 0, 1, 2, 3, 4, 5, 6, and the last day of mechanical ventilation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Castellà

Investigators

  • Principal Investigator: Manuel Castellà, MD PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/0464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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