Pilot Study on Cytokine Filtration in COVID-19 ARDS

Not Applicable

• Conditions: Coronavirus Infection; Acute Respiratory Distress Syndrome; COVID
• Interventions: Device: Cytokine Adsorption

• Registration Number: NCT04361526
• Lead Sponsor: Manuel Castellà

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-17
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytokine Adsorption	Cytokine Adsorption	cytokine adsorption plus standard intensive care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain