COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04528888

Massimo Girardis, PD

massimo.girardis@unimore.it

2020-08-27

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: 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

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.

3

Massimo Girardis

18

100

Italy

Critical disease at enrollment

8: Critical disease at enrollment

210

All-cause mortality at day 28

None

Phase 3

[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1630, "treatment_name": "Enoxaparin+methylprednisolone", "treatment_type": "Coagulation modifiers+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2230, "treatment_name": "Methylprednisolone+unfractioned heparin", "treatment_type": "Corticosteroids+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]