Sarilumab COVID-19

Phase 1

• Conditions: Corona virus infection; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001162-12-DE
• 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: 2020-03-20
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Participants must be =18 years of age
Participants must be hospitalized for less than or equal to 7 days with
evidence of pneumonia and have one of the following disease categories:
severe disease 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 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 264

Exclusion Criteria

Unlikely to survive after 48 hours from screening or unlikely to remain at
the investigational site beyond 48 hours. Patients with multi organ dysfunction or requiring extracorporeal life support or renal replacement
therapy are excluded.
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
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