Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)
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.
n/a
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