Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19

• Status: Completed
• Trial end date: 2020-04-23
• Target enrollment: 0
• Participant gender: All

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 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Collaborator: Fondazione "Un Cuore per Milano" - a no profit foundation
• Treatments: Aspirin; Clopidogrel; Fondaparinux; PENTA; Tirofiban

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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