Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection
Brief Summary

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

Completed
COVID-19

Drug: Baricitinib

Given orally
Other Name: LY3009104

Drug: Placebo

Given orally

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Brazil
Germany
India
Italy
Japan
Korea, Republic of
Mexico
Puerto Rico
Russian Federation
Spain
United Kingdom
United States
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 Martin, Buenos Aires, Argentina

Clinica Adventista Belgrano
Caba, Ciudad Autónoma De Buenos Aire, Argentina

Clinica Central S.A.
Villa Regina, Rio Negro, Argentina

Clinica Viedma
Viedma, Río Negro, Argentina

Hospital San Roque
Cordoba, Argentina

Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil

Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier
Curitiba, Parana, 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, RS, Brazil

Hospital Carlos Fernando Malzoni Matao
Matao, Sao Paulo, Brazil

Pesquisare
Santo Andre, Sao Paulo, Brazil

Praxis Pesquisa Medica
Santo André, Sao Paulo, Brazil

Faculdade de Medicina do ABC
Santo Andre, SP, 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

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, Bayern, Germany

Klinikum Rechts der Isar der TU München
München, Bayern, Germany

Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany

Klinikum Chemnitz gGmbH
Chemnitz, Germany

Sir Ganga Ram Hospital
New Delhi, Delhi, India

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

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
Milano, 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
Hachioji, Tokyo, Japan

Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, Korea, Republic of

Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of

Seoul National University Boramae Medical Center
Seoul, Seoul, Korea, Korea, Republic of

Seoul Medical Center
Seoul, Korea, Republic of

Instituto Nacional de Cardiologia Ignacio Chavez
Mexico, DF, Mexico

Instituto Nacional de Enfermedades Respiratorias
Mexico, DF, Mexico

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
Yucatan, Merida, Mexico

ITESM Campus Monterrey
Monterrey, Nuevo Leon, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico

Advanced Clinical Research, LLC
Bayamon, Puerto Rico

City Clinical Hospital #15 named after O.M. Filatov
Moscow, Russian Federation

First Moscow State Medical University n.a. Sechenov
Moscow, Russian Federation

Saint-Petersburg City Pokrovskaya Hospital
Saint-Petersburg, Russian Federation

Hospital Txagorritxu
Vitoria, Alava, Spain

Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, 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

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

Eli Lilly and Company
NCT Number
Keywords
Coronavirus
Coronavirus infection
safety
MeSH Terms
COVID-19