Clinical study aimed to verify the efficacy and safety of mavrilimumab in COVID-19-associated pneumonia in patients who have signs of excessive inflammatio

Phase 1

• Conditions: Respiratory failure during COVID-19 pneumonia and hyperinflammation; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001795-15-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-26
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adults (= 18 years old)
2. Signed informed consent
3. Patients clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology
4. Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with pulmonary infiltrates
5. Patient requiring oxygen supplementation (i.e. with a SpO2 = 94% while breathing room air) and having a PAO2/FIO2 ratio = 300 mmHg
6. Lactate dehydrogenase (LDH) > normal range and at least one of the following:
- fever > 38.0 °C;
- increased levels of C-reactive Protein (CRP) = 10x UNL mg/L (= 60 mg/lL);
- increased levels of ferritin = 2.5x UNL ( = 1000 ¿gmg/L)
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Onset of COVID-19 pneumonia symptoms (i.e. dyspnea/respiratory insufficiency) >14 days
2. On mechanical ventilation at the time of randomization
3. A PaO2/FiO2 < 100 mmHg
4. Uncontrolled systemic infection (other than COVID-19)
5. Hypersensitivity to the active substance or to any of the excipients of the experimental drug
6. Total neutrophil count < 1500/mm3
7. Severe hepatic cirrhosis
8. History of chronic HBV or HCV infection
9. Known or active tuberculosis (TB) or a history of incompletely treated TB; suspected or known extrapulmonary tuberculosis
10. Moderate/severe heart failure (NYHA Class 3 or 4)
11. Any prior (within the defined periods below) or concurrent use of immunosuppressive therapies including but not limited to the following:
a. Anti-IL-6, anti-IL-6R antagonists or Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period;
b. Cell-depleting agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level;
c. Anakinra within 1 week of baseline; canakinumab within 8 weeks of baseline; abatacept within 8 weeks of baseline.
d. Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer;
e. Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline;
f. Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide or methotrexate within 4 weeks of baseline.
12. Pregnancy or lactation (Note: Women of childbearing age should use effective contraception/abstinence after treatment with mavrilimumab and for 3 months after the dosing)
13. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
14. In the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours, irrespective of the provision of treatments
15. Current participation in any other interventional investigational trials

Study & Design

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