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

Primary Purpose

Coronavirus Infection, Acute Respiratory Distress Syndrome, COVID

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Cytokine Adsorption

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring COVID, ARDS, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Clínic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Cytokine Adsorption

Arm Description

standard intensive care alone

cytokine adsorption plus standard intensive care

Outcomes

Primary Outcome Measures

Mechanical ventilation-free days

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

length of ICU stay (days)

length of hospital stay

Duration of renal replacement and cathecolamines therapies

Need for extracorporeal membrane oxygenation (ECMO) support

multi-organ failure measured by the Sequential Organ Failure Assessment (SOFA) score

Full Information

NCT ID

NCT04361526

First Posted

April 21, 2020

Last Updated

April 23, 2020

Sponsor

Manuel Castellà

1. Study Identification

Unique Protocol Identification Number

NCT04361526

Brief Title

Pilot Study on Cytokine Filtration in COVID-19 ARDS

Acronym

CytokCOVID19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 17, 2020 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Manuel Castellà

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection, Acute Respiratory Distress Syndrome, COVID

Keywords

COVID, ARDS, Coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

standard intensive care alone

Arm Title

Cytokine Adsorption

Arm Type

Experimental

Arm Description

cytokine adsorption plus standard intensive care

Intervention Type

Device

Intervention Name(s)

Cytokine Adsorption

Intervention Description

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 Measure Information:

Title

Mechanical ventilation-free days

Description

Time Frame

up to 28days

Secondary Outcome Measure Information:

Title

30-day mortality

Time Frame

up to 30 days

Title

length of ICU stay (days)

Time Frame

up to 30 days

Title

length of hospital stay

Time Frame

up to 30 days

Title

Duration of renal replacement and cathecolamines therapies

Time Frame

up to 30 days

Title

Need for extracorporeal membrane oxygenation (ECMO) support

Time Frame

up to 30 days

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Manuel Castellà, MD PhD

Phone

+34932275515

mcaste@clinic.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Castellà, MD PhD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínic de Barcelona

City

Barcelona

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel Castellà, MD PhD

Phone

+34932275515

mcaste@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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31986264

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Pilot Study on Cytokine Filtration in COVID-19 ARDS

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