A Study of Baricitinib (LY3009104) in Participants With COVID-19

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04421027
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Given orally
  • Placebo — DRUG
    Given orally

Study Details

The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.

Key Dates

Start date
Jun 12, 2020
Status verified
Jul 2022
Primary completion
Feb 12, 2021
Completion
Jun 10, 2021

Study Design

Enrollment
1,525 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib + Standard of Care (SOC)
    4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.
  • Placebo Comparator: Placebo + SOC
    Placebo (given as two placebo tablets) administered orally QD with standard of care.

Primary Outcome Measure

Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) [ Time Frame: Day 1 to Day 28 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Dignity Health Mercy Gilbert Medical CenterGilbertArizona85297-
St Joseph's Hospital and Medical CenterPhoenixArizona85013-
Valleywise HealthPhoenixArizona85008-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Sharp Memorial HospitalSan DiegoCalifornia92123-
San Francisco VA Medical CenterSan FranciscoCalifornia94121-
Torrance Memorial Medical CenterTorranceCalifornia90505-
Holy Cross Hospital Inc.Fort LauderdaleFlorida33308-
Westchester General HospitalMiamiFlorida33155-
Grady Health SystemAtlantaGeorgia30303-
Atlanta VA Medical CenterDecaturGeorgia30033-
Great Lakes Clinical TrialsChicagoIllinois60640-
Parkview Regional Medical CenterFort WayneIndiana46845-
Community Hospital SouthIndianapolisIndiana46227-
Franciscan St. Francis HealthIndianapolisIndiana46237-
South Shore HospitalWeymouthMassachusetts02190-
Henry Ford HospitalDetroitMichigan48202-
Renown Regional Med. CenterRenoNevada89502-
SUNY DownstateBrooklynNew York11203-
East Carolina UniversityGreenvilleNorth Carolina27834-
OSU Med Intl Med Houston CtrTulsaOklahoma74127-
Oregon Health and Science UniversityPortlandOregon97239-
Temple Univ School of MedPhiladelphiaPennsylvania19140-
Swedish Medical CenterSeattleWashington98104-
MultiCare Good Samaritan HospitalTacomaWashington98405-

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