CytokCOVID19: Pilot Study on Cytokine Filtration in COVID-19 ARDS

Sponsor

Manuel Castellà (Other)

Overall Status

Unknown status

CT.gov ID

NCT04361526

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 aloneThis 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 :

Apr 17, 2020

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mechanical ventilation-free days [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Rise of inflammatory biomarkers: C-reactive protein (CRP) >10 mg/L

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic de Barcelona	Barcelona		Spain

Sponsors and Collaborators

Manuel Castellà

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:

Apr 24, 2020

Last Update Posted:

Apr 24, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Manuel Castellà, MD PhDHead of the Cardiovascular Surgery Department, Associate Professor, Principal Investigator, Hospital Clinic of Barcelona

COVID

ARDS

Coronavirus

Additional relevant MeSH terms:

Coronavirus Infections

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of Apr 24, 2020