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

Phase 1

• Conditions: critically-ill patients with pneumonia from COVID-19 infection; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001921-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-26
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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
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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 28 gg