A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patients with severe COVID-19 pneumonia .

Phase 1

• Conditions: Covid-19 coronavirus infection; MedDRA version: 20.1Level: HLTClassification code 10047468Term: Viral lower respiratory tract infectionsSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001390-76-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

1.Age = 18 years
2.Signed informed consent provided by the patient, or by the patient’s legally authorized representative(s), as applicable. Orally provisions could be considered in emergency conditions if deemed necessary by the investigator (signature of the informed consent will occur if and as soon as clinical conditions improve).
3.Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by PCR test or positive serology)
4.Evidence of pulmonary infiltrates at CT scan or Chest XRay
5.Oxygen saturation (SpO2) at rest without oxygen supplementation < 93% or PaO2/FiO2 < 300 at rest in patients requiring oxygen supplementation (either Venturi mask or cPAP or NIV).
6.Evidence of hyperinflammation defined as at least two of the following:
i.Blood lymphocytes <1000/mm3
ii. Ferritin > 500ng/mL;
iii.LDH > 300 U/L;
iv.D-Dimers > 1000 ng/mL
v.C-reactive protein > 3 mg/dL
7.Indication to start antiviral therapy with either hydroxychloroquine or lopinavir/ritonavir as regular clinical practice (or patients who have already started/finished antiviral therapy for SARS-CoV2)

8.Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix F.
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 71
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Known hypersensitivity to sarilumab or its excipients
2.Known active infections or other clinical condition that contraindicate sarilumab and cannot be treated or solved according to the judgement of the clinician
3.Patient being treated with immunomodulators or anti-rejection drugs
4.Pregnancy/lactation
5.Neutrophils count < 500 cell/mm3
6.Platelets count < 50.000/mm3
7.ALT / AST> 5 times the upper limit of the normality
8.Bowel diverticulitis or perforation
9.Existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
10.Severe hepatic dysfunction
11.Creatinine clearance < 30 ml/min/1.73 m2
12.Mechanical ventilation or ECMO
13.Enrolment in another concurrent clinical interventional study
14.Intake of an investigational drug within 3 months

Study & Design

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