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Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19

NCT04368377 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-04-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Tirofiban Injection

Patients will receive 25 microgram per kilogram of body weight tirofiban as bolus IV injection (3 minutes) followed by continuous infusion at a rate of 0,15 microgram/kg//minute for 48 hours.

DRUG

Clopidogrel

Patients will receive a loading dose of clopidogrel 300 mg PO, followed by 75mg daily for 30 days

DRUG

Acetylsalicylic acid

Patients will receive acetylsalicylic acid 250 mg IV before starting tirofiban, and this will be continued at a dose of 75mg daily for 30 days.

DRUG

Fondaparinux

Patients will receive concurrent fondaparinux 2.5mg s/c per day for the duration of the in hospital stay

Sponsors & Collaborators

  • Fondazione "Un Cuore per Milano" - a no profit foundation

    collaborator UNKNOWN

  • University of Milan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-06
Primary Completion
2020-04-23
Completion
2020-04-23

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368377 on ClinicalTrials.gov