Status:
COMPLETED
ANTIcoagulation in Severe COVID-19 Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a stat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years ;
- Severe COVID-19 pneumonia, defined by:
- A newly-appeared pulmonary parenchymal infiltrate; AND
- a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); AND
- WHO progression scale ≥ 5 (on The Who ordinal scale)
- Written informed consent (patient, next of skin or emergency situation).
- In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
Exclusion
- Pregnancy and breast feeding woman;
- Postpartum (6 weeks);
- Extreme weights (\<40 kg or \>100 kg);
- Patients admitted since more than 72 hours to the hospital (if the WHO ordinal scale is 5 at time of inclusion) or since more than 72 hours to the intensive care unit (if the WHO ordinal scale is 6 or more at time of inclusion);
- Need for therapeutic anticoagulation (except for COVID-related pulmonary thrombosis);
- Bleeding event related to hemostasis disorders, acute clinically significant bleed, current gastrointestinal ulcer or any organic lesion with high risk for bleeding
- Platelet count \< 50 G/L;
- Within 15 days of recent surgery, within 24 hours of spinal or epidural anesthesia;
- Any prior intracranial hemorrhage, enlarged acute ischemic stroke, known intracranial malformation or neoplasm, acute infectious endocarditis;
- Severe renal failure (creatinine clearance \<30 mL/min);
- Iodine allergy;
- Hypersensitivity to heparin or its derivatives including low-molecular-weight heparin;
- History of type II heparin-induced thrombocytopenia;
- Chronic oxygen supplementation;
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty and persons subject to institutional psychiatric care;
- Patients under guardianship or curatorship;
- Participation to another interventional research on anticoagulation.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2022
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT04808882
Start Date
April 14 2021
End Date
March 13 2022
Last Update
September 8 2022
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94000