Status:
UNKNOWN
Pilot Study on Cytokine Filtration in COVID-19 ARDS
Lead Sponsor:
Manuel Castellà
Conditions:
Coronavirus Infection
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 sever...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04361526
Start Date
April 17 2020
End Date
July 1 2020
Last Update
April 24 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínic de Barcelona
Barcelona, Spain