COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04808882

None

None

2021-03-22

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: 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.

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.

3

Assistance Publique - Hôpitaux de Paris

18

100

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

353

All-cause mortality;Number of days to clinical improvement

None

Phase 2

[{"arm_notes": "3500 IU/24h", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "7000 IU/24h", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "175 IU/kg/24h", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]