Status:
COMPLETED
Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Fondazione "Un Cuore per Milano" - a no profit foundation
Conditions:
Pneumonia, Viral
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban...
Detailed Description
It is a investigator-initiated, compassionate use, prospective, phase 2b, non randomized, open-label, proof of concept study in which the investigators will evaluate the effects of compassionate-use t...
Eligibility Criteria
Inclusion
- Laboratory-confirmed SARS-CoV-2-related pneumonia, defined as positive nasal swab for SARS-CoV-2 infection or positive IgM serum title. A laboratory confirmed diagnosis must be associated with a clinically confirmed COVID-19 pneumonia, with a history of fever ≥ 3 days and multiple pulmonary infiltrates at the chest X-Ray
- Acute de novo severe hypoxic respiratory failure, defined by means of arterial blood gas analysis performed in room air showing severe hypoxemia with an arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio \< 250 (according to the Berlin 2012 acute respiratory distress syndrome - ARDS - definition), requiring CPAP respiratory support
- D-Dimer value ≥ 3 times the upper level of normal of the laboratory
Exclusion
- Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks
- Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks
- Laboratory confirmed Laboratory confirmed Glucose 6-Phosphate Dehydrogenase (G6PDH) deficiency.
- Confirmed or suspected pregnancy or patients in childbearing age.
- Previous known adverse effects or intolerance to the study drugs
- Ongoing septic shock. Septic shock will be defined as the concomitant presence of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection with a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more) and need for vasopressors to maintain a mean arterial pressure of 65 mm Hg or greater and a serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia.
- Need for surgery during hospitalization
- Elevated risk of in hospital fall
- Glasgow Coma Scale \<15
- Confirmed diagnosis of dementia or mental disability that jeopardizes the comprehension of the study protocol
- Inability to sign the informed consent
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04368377
Start Date
April 6 2020
End Date
April 23 2020
Last Update
April 29 2020
Active Locations (1)
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1
L. Sacco Hospital
Milan, Lombardy, Italy, 20157