Clinical trial of Sarilumab in adults hospitalized with COVID-19

Phase 1

• Conditions: SARS-CoV-2 infection causing respiratory disease and cytokine release syndrome; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001531-27-ES
• Lead Sponsor: Fundación para la Investigación Biomédica de Córdoba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age = 18 years and <75 years
2. Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
3. Interstitial pneumonia confirmed by chest radiography or CT
4. IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
5. Negative pregnancy test in women of childbearing age
6. Signature of informed consent
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. SOFA score> 6 points
2. Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
3. Neutrophil count <2 x 103 / µL
4. Platelet count <100 x 103 / µL
5. ALT or AST levels> 5 times the upper limit of normal
6. Severe renal failure (CrCr <30 ml / min)
7. Active bacterial infectious process
8. Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
9. History of intestinal ulcer or diverticulitis
10. History of hypersensitivity reactions to Sarilumab or its excipients
11. Treatment with TNF antagonists
13. Previous treatment with anti-IL6 in the previous 30 days
14. Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
15. Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
16. Patients on immunosuppressive treatment for any cause
17. HIV-infected patients with CD4 <200 / mm3
18. Past or current history of autoimmune disease or systemic inflammatory disease
19. Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
20. Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
21. Pregnancy
22. Any other condition that, in clinical judgment, prevents adherence to the patient's protocol

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Decrease cases of ARDS in adults requiring HFNO or either non-invasive or invasive mechanical ventilation;Secondary Objective: To reduce crude mortality at 28 days<br>To reduce the time (in days) to clinical improvement<br>To reduce the time (in days) until improvement in oxygenation for at least 48 hours<br>To reduce the proportion of patients who require invasive mechanical ventilation<br>To study the effect of the drug on the negativization of the PCR to COVID-19<br>To study the effect of the drug on the profile of cytokines<br>To study the safety of the experimental drug;Primary end point(s): Proportion of patients requiring or time (in days) until required:<br>- High flow nasal oxygenation (HFNO)<br>- Non-invasive mechanical ventilation type BiPAP<br>- Non-invasive mechanical ventilation type CPAP<br>- Invasive mechanical ventilation;Timepoint(s) of evaluation of this end point: At day 28 or when the subject is discharged (whichever occurs first)