Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)
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|ClinicalTrials.gov Identifier: NCT04361526|
Recruitment Status : Unknown
Verified April 2020 by Manuel Castellà, Hospital Clinic of Barcelona.
Recruitment status was: Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|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|
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.
- 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
- 30-day mortality [ Time Frame: up to 30 days ]
- length of ICU stay (days) [ Time Frame: up to 30 days ]
- length of hospital stay [ Time Frame: up to 30 days ]
- Duration of renal replacement and cathecolamines therapies [ Time Frame: up to 30 days ]
- Need for extracorporeal membrane oxygenation (ECMO) support [ Time Frame: 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) ]
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
|Contact: Manuel Castellà, MD PhDfirstname.lastname@example.org|
|Hospital Clínic de Barcelona||Recruiting|
|Contact: Manuel Castellà, MD PhD +34932275515 email@example.com|
|Principal Investigator:||Manuel Castellà, MD PhD||Hospital Clinic of Barcelona|