.Sarilumab COVID-19

Phase 1

• Conditions: Corona virus Infection; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001162-12-IT
• Lead Sponsor: Sanofi-aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Study Completion: 2020-09-02
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Participants must have severe disease, multi-system organ dysfunction or critical disease
Laboratory-confirmed SARS-CoV-2 infection
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 184
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 276

Exclusion Criteria

Unlikely to survive for >48 hours from screening
Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than 5 X ULN, platelets less than 50,000/mmˆ3
Prior immunosuppressive therapies
Use of chronic oral corticosteroids for non-COVID-19 related condition
Past or current history of autoimmune or inflammatory disease(s)
Known or suspected history of tuberculosis
Suspected or known active systemic bacterial or fungal infections

Study & Design

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