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

NCT04421027 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 17830I4V-MC-KHAA2020-001517-21
• Study Type: interventional
• Target: 1,525
• Locations: 13 countries
• Sites: 96

Brief Summary

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

Conditions

COVID-19

Keywords

coronavirus; coronavirus infection; safety

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])

  Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).

  Day 1 to Day 28

• Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2

  Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.

  Day 1 to Day 28

Secondary Outcomes (19)

• Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital

  Day 10

• Number of Ventilator-Free Days

  Day 1 to Day 28

• Time to Recovery

  Day 1 to Day 28

• Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4

  Day 4

• Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7

  Day 7

Study Arms (2)

Baricitinib + Standard of Care (SOC)

EXPERIMENTAL

4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.

Drug: Baricitinib

Placebo + SOC

PLACEBO COMPARATOR

Placebo (given as two placebo tablets) administered orally QD with standard of care.

Drug: Placebo

Interventions

Baricitinib DRUG

Given orally

Also known as: LY3009104

Baricitinib + Standard of Care (SOC)

Placebo DRUG

Given orally

Placebo + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
• PCR positive in sample collected \<72 hours prior to randomization; OR
• PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
• Requires supplemental oxygen at the time of study entry and at randomization.
• Have indicators of risk of progression: at least 1 inflammatory markers \>upper limit of normal (ULN) (C reactive protein \[CRP\], D dimer, lactate dehydrogenase \[LDH\], ferritin) with at least 1 instance of elevation \>ULN within 2 days before study entry.

You may not qualify if:

• Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor \[TNF\] inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
• Have ever received convalescent plasma or intravenous immunoglobulin \[IVIg\]) for COVID-19.
• Have received high dose corticosteroids at doses \>20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
• Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
• Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19.
• Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
• Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
• Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
• Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
• Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
• Have a history of venous thromboembolism (VTE) (deep vein thrombosis \[DVT\] and/or pulmonary embolism \[PE\]) within 12 weeks prior to randomization or have a history of recurrent (\>1) VTE (DVT/PE).
• Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
• Have neutropenia (absolute neutrophil count \<1000 cells/microliters).
• Have lymphopenia (absolute lymphocyte count \<200 cells/microliters).
• Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times ULN.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (96)

Dignity Health Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

St Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Holy Cross Hospital Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Westchester General Hospital

Miami, Florida, 33155, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Community Hospital South

Indianapolis, Indiana, 46227, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Renown Regional Med. Center

Reno, Nevada, 89502, United States

Location

SUNY Downstate

Brooklyn, New York, 11203, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

OSU Med Intl Med Houston Ctr

Tulsa, Oklahoma, 74127, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Temple Univ School of Med

Philadelphia, Pennsylvania, 19140, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

MultiCare Good Samaritan Hospital

Tacoma, Washington, 98405, United States

Location

Sanatorio Sagrado Corazón

Ciudad de Buenos Aires, AR, C1039AAC, Argentina

Location

ClÃ-nica Zabala

Ciudad de Buenos Aires, AR, C1426AAM, Argentina

Location

Hospital Z.G.A.D "Evita Pueblo"

Berazategui, Buenos Aires, 1884, Argentina

Location

Sanatorio de la Trinidad Mitre

CABA, Buenos Aires, C1039AAO, Argentina

Location

Fundacion Sanatorio Guemes

CABA, Buenos Aires, C1180AAX, Argentina

Location

Casa Hospital San Juan de Dios

Ramos Mejía, Buenos Aires, 1704, Argentina

Location

Hospital Interzonal General de Agudos "Eva Peron"

San Martín, Buenos Aires, B1650 NBN, Argentina

Location

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina

Location

Clinica Viedma

Viedma, Río Negro Province, 8500, Argentina

Location

Clinica Central S.A.

Villa Regina, Río Negro Province, R8336, Argentina

Location

Hospital San Roque

Córdoba, 5000, Argentina

Location

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

Location

Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier

Curitiba, Paraná, 80035-090, Brazil

Location

CEPETI Centro de Ensino e Pesquisa em Terapia Intensiva

Curitiba, Paraná, 82530-200, Brazil

Location

CPCLIN

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, 18618-687, Brazil

Location

IPECC - Instituto de Pesquisa Clinica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

Hospital PUC-CAMPINAS

Campinas, São Paulo, 13060-904, Brazil

Location

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, 17201-130, Brazil

Location

Hospital Carlos Fernando Malzoni Matao

Matão, São Paulo, 15990-060, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

Location

Pesquisare

Santo André, São Paulo, 09080-110, Brazil

Location

Praxis Pesquisa Medica

Santo André, São Paulo, 09090-790, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Real e Benemerita Associação Portuguesa de Beneficiencia

São Paulo, 01323-900, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, 01327-001, Brazil

Location

Universidade Federal de São Paulo - Escola Paulista de Medicina

São Paulo, 04037-002, Brazil

Location

Hospital Santa Paula

São Paulo, 04556-100, Brazil

Location

Casa de Saude Santa Marcelina - Centro de Pesquisa Clinica

São Paulo, 08270-120, Brazil

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Klinikum Rechts der Isar der TU München

München, Bavaria, 81675, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Unity Hospital

Surat, Gujarat, 395010, India

Location

Medanta-The Medicity

Gurgaon, Haryana, 122001, India

Location

Government Medical College (GMC) Aurangabad

Aurangabad, Maharashtra, 431001, India

Location

Government Medical College

Nagpur, Maharashtra, 440003, India

Location

Ruby Hall Clinic and Grant Medical Foundation

Pune, Maharashtra, 411001, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Medica Superspecialty Hospital

Kolkata, West Bengal, 700099, India

Location

Aakash Healthcare Super Speciality Hospital

New Delhi, 110075, India

Location

INMI Lazzaro Spallanzani

Roma, Rome, 00149, Italy

Location

Ospedale Niguarda Ca Granda

Milan, 20162, Italy

Location

Nuovo Ospedale di Prato S. Stefano

Prato, 59100, Italy

Location

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, 2210855, Japan

Location

Edogawa Medicare Hospital

Edagawa, Tokyo, 133 0071, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 193-0998, Japan

Location

Instituto Nacional de Cancerologia

Mexico City, FD, 14080, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir

Mexico City, Federal District, 14080, Mexico

Location

Hospital General Agustín O'Horán

Yucatán, Merida, 97000, Mexico

Location

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, 14080, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, 14080, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

ITESM Campus Monterrey

Monterrey, Nuevo León, 64710, Mexico

Location

Advanced Clinical Research, LLC

Bayamón, PR, 00961, Puerto Rico

Location

City Clinical Hospital #15 named after O.M. Filatov

Moscow, 111539, Russia

Location

First Moscow State Medical University n.a. Sechenov

Moscow, 119991, Russia

Location

Saint-Petersburg City Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, Seoul, Korea, 07061, South Korea

Location

Seoul Medical Center

Seoul, 02053, South Korea

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, 28031, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

The Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Barnet Hospital

Barnet, Herts, EN5 3DJ, United Kingdom

Location

St. George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Related Publications (3)

• Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.

  PMID: 35695334 DERIVED

• Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD, Saraiva JFK, Chakladar S, Marconi VC; COV-BARRIER Study Group. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. doi: 10.1016/S2213-2600(22)00006-6. Epub 2022 Feb 3.

  PMID: 35123660 DERIVED

• Marconi VC, Ramanan AV, de Bono S, Kartman CE, Krishnan V, Liao R, Piruzeli MLB, Goldman JD, Alatorre-Alexander J, de Cassia Pellegrini R, Estrada V, Som M, Cardoso A, Chakladar S, Crowe B, Reis P, Zhang X, Adams DH, Ely EW; COV-BARRIER Study Group. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Respir Med. 2021 Dec;9(12):1407-1418. doi: 10.1016/S2213-2600(21)00331-3. Epub 2021 Sep 1.

  PMID: 34480861 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-595-5979

Study Officials

• Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 12, 2020
• Primary Completion: February 12, 2021
• Study Completion: June 10, 2021
• Last Updated: July 28, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
• Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting

Locations

ES (5); AR (11); IN (8); KR (4); IT (3); DE (4); US (25); GB (3); ME (7); JP (3); BR (19); PR (1); RU (3)