The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.
Drug: Baricitinib
Given orally
Other Name: LY3009104
Drug: Placebo
Given orally
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.
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