Respiratory Failure Clinical Trial
— PIC-19Official title:
Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol
Verified date | April 2020 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 5 |
Est. completion date | April 23, 2020 |
Est. primary completion date | April 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | L. Sacco Hospital | Milano | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Milan | Fondazione "Un Cuore per Milano" - a no profit foundation |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | P/F ratio | Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment | At baseline and 24, 48 and 168 hours after treatment initiation | |
Primary | PaO2 difference | Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment | At baseline and 24, 48 and 168 hours after treatment initiation | |
Primary | A-a O2 difference | Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood. | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | CPAP duration | Number of days on continuous positive end expiratory pressure (CPAP) | From the first day of study drugs administration (T0) until day 7 post study drugs administration | |
Secondary | In-hospital change in intensity of the respiratory support | Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation | At baseline and 72 and 168 hours after treatment initiation | |
Secondary | PaCO2 difference | Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | HCO3- difference | Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | Lactate difference | Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | Hb difference | Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment. | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | Plt difference | Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment. | At baseline and 24, 48 and 168 hours after treatment initiation | |
Secondary | Adverse effects | Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding) | From the first day of study drugs administration until day 30 post study drugs administration |
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