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

NCT ID: NCT04421027

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2021-06-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Given orally

Placebo + SOC

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Given orally

Interventions

Baricitinib

Given orally

Intervention Type: DRUG

Placebo

Given orally

Intervention Type: DRUG

Other Intervention Names

LY3009104

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
• Have a known hypersensitivity to baricitinib or any of its excipients.
• Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
• Are pregnant, or intend to become pregnant or breastfeed during the study.
• Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
• Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Dignity Health Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Valleywise Health

Phoenix, Arizona, United States

St Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Sharp Memorial Hospital

San Diego, California, United States

San Francisco VA Medical Center

San Francisco, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Holy Cross Hospital Inc.

Fort Lauderdale, Florida, United States

Westchester General Hospital

Miami, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Community Hospital South

Indianapolis, Indiana, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

South Shore Hospital

Weymouth, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Renown Regional Med. Center

Reno, Nevada, United States

SUNY Downstate

Brooklyn, New York, United States

East Carolina University

Greenville, North Carolina, United States

OSU Med Intl Med Houston Ctr

Tulsa, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Temple Univ School of Med

Philadelphia, Pennsylvania, United States

Swedish Medical Center

Seattle, Washington, United States

MultiCare Good Samaritan Hospital

Tacoma, Washington, United States

Sanatorio Sagrado Corazón

Ciudad de Buenos Aires, AR, Argentina

ClÃ-nica Zabala

Ciudad de Buenos Aires, AR, Argentina

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

Berazategui, Buenos Aires, Argentina

Sanatorio de la Trinidad Mitre

CABA, Buenos Aires, Argentina

Fundacion Sanatorio Guemes

CABA, Buenos Aires, Argentina

Casa Hospital San Juan de Dios

Ramos Mejía, Buenos Aires, Argentina

Hospital Interzonal General de Agudos "Eva Peron"

San Martín, Buenos Aires, Argentina

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Clinica Central S.A.

Villa Regina, Río Negro Province, Argentina

Hospital San Roque

Córdoba, , Argentina

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, Brazil

Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier

Curitiba, Paraná, Brazil

CEPETI Centro de Ensino e Pesquisa em Terapia Intensiva

Curitiba, Paraná, Brazil

CPCLIN

Natal, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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

Botucatu, São Paulo, Brazil

IPECC - Instituto de Pesquisa Clinica de Campinas

Campinas, São Paulo, Brazil

Hospital PUC-CAMPINAS

Campinas, São Paulo, Brazil

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, Brazil

Hospital Carlos Fernando Malzoni Matao

Matão, São Paulo, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Pesquisare

Santo André, São Paulo, Brazil

Praxis Pesquisa Medica

Santo André, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

São Bernardo do Campo, São Paulo, Brazil

Real e Benemerita Associação Portuguesa de Beneficiencia

São Paulo, , Brazil

Hospital Alemão Oswaldo Cruz

São Paulo, , Brazil

Universidade Federal de São Paulo - Escola Paulista de Medicina

São Paulo, , Brazil

Hospital Santa Paula

São Paulo, , Brazil

Casa de Saude Santa Marcelina - Centro de Pesquisa Clinica

São Paulo, , Brazil

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Klinikum Rechts der Isar der TU München

München, Bavaria, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Unity Hospital

Surat, Gujarat, India

Medanta-The Medicity

Gurgaon, Haryana, India

Government Medical College (GMC) Aurangabad

Aurangabad, Maharashtra, India

Government Medical College

Nagpur, Maharashtra, India

Ruby Hall Clinic and Grant Medical Foundation

Pune, Maharashtra, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Medica Superspecialty Hospital

Kolkata, West Bengal, India

Aakash Healthcare Super Speciality Hospital

New Delhi, , India

INMI Lazzaro Spallanzani

Roma, Rome, Italy

Ospedale Niguarda Ca Granda

Milan, , Italy

Nuovo Ospedale di Prato S. Stefano

Prato, , Italy

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, Japan

Edogawa Medicare Hospital

Edagawa, Tokyo, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, Japan

Instituto Nacional de Cancerologia

Mexico City, FD, Mexico

Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir

Mexico City, Federal District, Mexico

Hospital General Agustín O'Horán

Yucatán, Merida, Mexico

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, Mexico

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

ITESM Campus Monterrey

Monterrey, Nuevo León, Mexico

Advanced Clinical Research, LLC

Bayamón, PR, Puerto Rico

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

Moscow, , Russia

First Moscow State Medical University n.a. Sechenov

Moscow, , Russia

Saint-Petersburg City Pokrovskaya Hospital

Saint Petersburg, , Russia

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Boramae Medical Center

Seoul, Seoul, Korea, South Korea

Seoul Medical Center

Seoul, , South Korea

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

The Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Barnet Hospital

Barnet, Herts, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, , United Kingdom

Countries

United States; Argentina; Brazil; Germany; India; Italy; Japan; Mexico; Puerto Rico; Russia; South Korea; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35695334 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35123660 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34480861 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/1QT4STirLDGakzCVTBX2Rv

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

Other Identifiers

I4V-MC-KHAA

Identifier Type: OTHER

Identifier Source: secondary_id

2020-001517-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17830

Identifier Type: -

Identifier Source: org_study_id