Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design.

Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design. - Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infectio

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001921-30-IT

Enrollment

200

Registered

2020-06-26

Start date

2020-05-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

critically-ill patients with pneumonia from COVID-19 infection MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862

Interventions

Trade Name: SOLU MEDROL Product Name: Metilprednisolone sodio succinato Product Code: [-] Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: METILPREDNISOLONE Curr

Eligibility

Sex/Gender

All

Inclusion criteria

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 6 x upper limit of local reference range - PCR > 6 fold upper limit of local reference range Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin or with steroids and molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The confirmation of the efficacy of this composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.;Secondary Objective: -;Primary end point(s): All-cause mortality at day 28;Timepoint(s) of evaluation of this end point: 28 day	—

Measure

Time frame

Main Objective: The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin or with steroids and molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The confirmation of the efficacy of this composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.;Secondary Objective: -;Primary end point(s): All-cause mortality at day 28;Timepoint(s) of evaluation of this end point: 28 day

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 28 gg	—

Countries

Italy

Contacts

Public ContactClinical Trials Quality Team

Azienda Ospedaliero-Universitaria di Modena

mighali.pasquale@aou.mo.it0594224369

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026