| Study name |
Steroids and unfractionated heparin in critically‐ill patients with pneumonia from COVID‐19 infection. A multicenter, interventional, randomised, three arms study design |
| Methods |
Trial design: open RCT
Sample size: 200
Setting: inpatient
Language: Italian, English
Number of centres: 9
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Positive SARS‐CoV‐2 diagnostic (on pharyngeal swab of deep airways material) Positive pressure ventilation (either non‐invasive or invasive) from > 24 h Invasive mechanical ventilation from < 96 h 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 criteria
Age < 18 years Ongoing treatment with anticoagulant drugs Platelet count < 100,000/mm3 History of heparin‐induced thrombocytopenia Allergy to sodium enoxaparine or other LMWH, unfractionated heparin or methylprednisolone Active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment Recent (in the last 1 month prior to randomisation) brain, spinal or ophthalmic surgery Chronic intake of corticosteroids (we corrected "Chronic assumption or oral corticosteroids" as stated in the trial register by translating "Assunzione cronica di corticosteroidi") 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
|
| Interventions |
Details of intervention: methylprednisolone + unfractionated heparin (Eparina)
Dose: methylprednisolone (125 to 1000 mg/mL) + unfractionated heparin (Eparina) (25,000 international units) Route of administration: IV
Treatment details of control group (e.g. dose, route of administration): heparin subcutaneous (25,000 international units)
Concomitant therapy: no information |
| Outcomes |
Primary study outcome: all‐cause mortality at day 28 |
| Starting date |
14 May 2020 |
| Contact information |
Clinical Trials Quality Team: 0594225868
Email: mighali.pasquale@aou.mo.it |
| Notes |
Recruitment status: ongoing
Prospective completion date: 1 year later, so May 2021
Date last update was posted: 26 June 2020
Sponsor/funding: AZIENDA OSPEDALIERO‐UNIVERSITARIA POLICLINICO DI MODENA |
