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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361526
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Castellà, Hospital Clinic of Barcelona

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Acute Respiratory Distress Syndrome COVID Device: Cytokine Adsorption Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-branch randomized, controlled, uni-center study. Eligible patients will be randomly assigned in a 1:1 ratio to receive cytokine filtration plus standard intensive care, or standard intensive care alone
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: up to 30 days ]
  2. length of ICU stay (days) [ Time Frame: up to 30 days ]
  3. length of hospital stay [ Time Frame: up to 30 days ]
  4. Duration of renal replacement and cathecolamines therapies [ Time Frame: up to 30 days ]
  5. Need for extracorporeal membrane oxygenation (ECMO) support [ Time Frame: up to 30 days ]
  6. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361526


Contacts
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Contact: Manuel Castellà, MD PhD +34932275515 mcaste@clinic.cat

Locations
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Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain
Contact: Manuel Castellà, MD PhD    +34932275515    mcaste@clinic.cat   
Sponsors and Collaborators
Manuel Castellà
Investigators
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Principal Investigator: Manuel Castellà, MD PhD Hospital Clínic de Barcelona
Publications:

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Responsible Party: Manuel Castellà, MD PhDHead of the Cardiovascular Surgery Department, Associate Professor, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04361526    
Other Study ID Numbers: HCB/2020/0464
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel Castellà, Hospital Clinic of Barcelona:
COVID
ARDS
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury
Respiratory Tract Infections