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Status:

COMPLETED

Sarilumab COVID-19

Lead Sponsor:

Sanofi

Collaborating Sponsors:

Regeneron Pharmaceuticals

Conditions:

Corona Virus Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19). Secondar...

Detailed Description

An individual participant would complete the study approximately 60 days from screening to follow-up on day 60 ±7 days.

Eligibility Criteria

Inclusion

  • 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 severe acute respiratory syndrome coronavirus 2 infection.
  • Exclusion criteria:
  • Unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours. Participants with multi organ dysfunction or requiring extracorporeal life support or renal replacement therapy were excluded.
  • Presence of neutropenia less than 2000/cubic millimeter (mmˆ3), aspartate transaminase or ALT greater than 5X ULN, platelets less than 50,000/mmˆ3.
  • Prior immunosuppressive therapies. Use of systemic chronic corticosteroids for non-COVID-19 related condition. Known or suspected history of tuberculosis. Suspected or known active systemic bacterial or fungal infections.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    March 28 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 2 2020

    Estimated Enrollment :

    420 Patients enrolled

    Trial Details

    Trial ID

    NCT04327388

    Start Date

    March 28 2020

    End Date

    September 2 2020

    Last Update

    September 24 2025

    Active Locations (47)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (47 locations)

    1

    Investigational Site Number 0320001

    Caba, Argentina, 1430

    2

    Investigational Site Number 0320003

    Caba, Argentina, C1180AAX

    3

    Investigational Site Number 0320004

    Caba, Argentina, C1426AAM

    4

    Investigational Site Number 0760003

    Porto Alegre, Brazil, 90110-270