Status:
UNKNOWN
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection
Lead Sponsor:
Massimo Girardis
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombo...
Detailed Description
Rationale It is very likely that the most severe manifestations of COVID-19 may be linked to an excessive and aberrant hyper-inflammatory host immune response along with pro-thrombotic derangements of...
Eligibility Criteria
Inclusion
- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
- Positive pressure ventilation (either non-invasive or invasive) from \> 24 hours
- Invasive mechanical ventilation from \< 96 hours
- P/F ratio \< 150
- D-dimer level \> 6 x upper limit of local reference range
- PCR \> 6 fold upper limit of local reference range
Exclusion
- Age \< 18 years
- On-going treatment with anticoagulant drugs
- Platelet count \<100.000/mmc
- History of heparin-induced thrombocytopenia
- Allergy to sodium enoxaparine or other LMWH, unfractionated heparin or metylprednisolone;
- Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
- Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
- Chronic assumption or oral corticosteroids
- Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;
- Clinical decision to withhold life-sustaining treatment or "too sick to benefit";
- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
- Lack or withdrawal of informed consent.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04528888
Start Date
November 25 2020
End Date
July 30 2021
Last Update
May 6 2021
Active Locations (1)
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1
ICU- University Hospital Modena
Modena, Italy, 41124