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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 1525
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5000
    • Hospital San Roque
  • AR
    • Ciudad de Buenos Aires, AR, Argentina, C1039AAC
      • Sanatorio Sagrado Corazon
    • Ciudad de Buenos Aires, AR, Argentina, C1426AAM
      • ClÃ-nica Zabala
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1884
      • Hospital Z.G.A.D "Evita Pueblo"
    • Caba, Buenos Aires, Argentina, C1039AAO
      • Sanatorio de la Trinidad Mitre
    • Caba, Buenos Aires, Argentina, C1180AAX
      • Fundacion Sanatorio Güemes
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • Casa Hospital San Juan de Dios
    • San Martin, Buenos Aires, Argentina, B1650 NBN
      • Hospital Interzonal General de Agudos "Eva Peron"
  • Ciudad Autónoma De Buenos Aire
    • Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF
      • Clinica Adventista Belgrano
  • Rio Negro
    • Villa Regina, Rio Negro, Argentina, R8336
      • Clinica Central S.A.
  • Río Negro
    • Viedma, Río Negro, Argentina, 8500
      • Clinica Viedma
• Brazil
  • São Paulo, Brazil, 01323-900
    • Real e Benemerita Associação Portuguesa de Beneficiencia
  • São Paulo, Brazil, 01327-001
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 04037-002
    • Universidade Federal de São Paulo - Escola Paulista de Medicina
  • São Paulo, Brazil, 04556-100
    • Hospital Santa Paula
  • São Paulo, Brazil, 08270-120
    • Casa de Saude Santa Marcelina - Centro de Pesquisa Clinica
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Hospital Felicio Rocho
  • Parana
    • Curitiba, Parana, Brazil, 80035-090
      • Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier
  • Paraná
    • Curitiba, Paraná, Brazil, 82530-200
      • CEPETI Centro de Ensino e Pesquisa em Terapia Intensiva
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59025-050
      • CPCLIN
  • SP
    • Santo Andre, SP, Brazil, 09060-870
      • Faculdade de Medicina do ABC
  • Sao Paulo
    • Matao, Sao Paulo, Brazil, 15990-060
      • Hospital Carlos Fernando Malzoni Matao
    • Santo Andre, Sao Paulo, Brazil, 09080-110
      • Pesquisare
    • Santo André, Sao Paulo, Brazil, 09090-790
      • Praxis Pesquisa Medica
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618-687
      • Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
    • Campinas, São Paulo, Brazil, 13060-080
      • IPECC - Instituto de Pesquisa Clínica de Campinas
    • Campinas, São Paulo, Brazil, 13060-904
      • Hospital PUC-CAMPINAS
    • Jaú, São Paulo, Brazil, 17201-130
      • CECIP - Centro de Estudos do Interior Paulista
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
• Germany
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitätsklinikum Erlangen
    • München, Bayern, Germany, 81675
      • Klinikum rechts der Isar der TU München
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein
• India
  • New Delhi, India, 110075
    • Aakash Healthcare Super Speciality Hospital
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital
  • Gujarat
    • Surat, Gujarat, India, 395010
      • Unity Hospital
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Medanta-The Medicity
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Government Medical College (GMC) Aurangabad
    • Nagpur, Maharashtra, India, 440003
      • Government Medical College
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic and Grant Medical Foundation
  • West Bengal
    • Kolkata, West Bengal, India, 700099
      • Medica Superspecialty Hospital
• Italy
  • Milano, Italy, 20162
    • Ospedale Niguarda Cà Granda
  • Prato, Italy, 59100
    • Nuovo Ospedale di Prato S. Stefano
  • Rome
    • Roma, Rome, Italy, 00149
      • INMI Lazzaro Spallanzani
• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 2210855
      • Yokohama Municipal Citizen's Hospital
  • Tokyo
    • Edagawa, Tokyo, Japan, 133 0071
      • Edogawa Medicare Hospital
    • Hachioji, Tokyo, Japan, 193-0998
      • Tokyo Medical University Hachioji Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 02053
    • Seoul Medical Center
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Seoul, Korea
    • Seoul, Seoul, Korea, Korea, Republic of, 07061
      • Seoul National University Boramae Medical Center
• Mexico
  • DF
    • Mexico, DF, Mexico, 14080
      • Instituto Nacional de Cardiologia Ignacio Chavez
    • Mexico, DF, Mexico, 14080
      • Instituto Nacional de Enfermedades Respiratorias
  • FD
    • Mexico City, FD, Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Federal District
    • Mexico City, Federal District, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir
  • Merida
    • Yucatan, Merida, Mexico, 97000
      • Hospital General Agustín O'Horán
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • ITESM Campus Monterrey
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Advanced Clinical Research, LLC
• Russian Federation
  • Moscow, Russian Federation, 111539
    • City Clinical Hospital #15 named after O.M. Filatov
  • Moscow, Russian Federation, 119991
    • First Moscow State Medical University n.a. Sechenov
  • Saint-Petersburg, Russian Federation, 199106
    • Saint-Petersburg City Pokrovskaya Hospital
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor-INTERNAL MED
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Alava
    • Vitoria, Alava, Spain, 01009
      • Hospital Txagorritxu
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid
• United Kingdom
  • London, United Kingdom, SW17 0QT
    • St. George's University Hospitals NHS Foundation Trust
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • The Royal Cornwall Hospital
  • Herts
    • Barnet, Herts, United Kingdom, EN5 3DJ
      • Barnet Hospital
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Dignity Health Mercy Gilbert Medical Center
    • Phoenix, Arizona, United States, 85008
      • Valleywise Health
    • Phoenix, Arizona, United States, 85013
      • St Joseph's Hospital and Medical Center
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc.
    • Miami, Florida, United States, 33155
      • Westchester General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
    • Indianapolis, Indiana, United States, 46227
      • Community Hospital South
  • Massachusetts
    • Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Med. Center
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • OSU Med Intl Med Houston Ctr
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Univ School of Med
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center
    • Tacoma, Washington, United States, 98405
      • MultiCare Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Baricitinib; Given orally; Other Names: LY3009104
Placebo Comparator: Placebo + SOC; Placebo (given as two placebo tablets) administered orally QD with standard of care.	Drug: Placebo; Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.	Day 10
Number of Ventilator-Free Days	Number of days free of invasive mechanical ventilation.	Day 1 to Day 28
Time to Recovery	Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)	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	Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.	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	Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.	Day 7
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10	Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.	Day 10
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14	Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.	Day 14
Duration of Hospitalization	Duration of hospitalization.	Days 1 to Day 28
Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline	Percentage of participants with a change in oxygen saturation from < 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.	Day 10
Overall Mortality	Number of deaths by Day 28.	Day 1 to Day 28
Duration of Stay in the Intensive Care Unit (ICU) in Days	Duration of stay in the ICU in days.	Day 1 to Day 28
Time to Clinical Deterioration (One-category Increase on the NIAID-OS)	The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.	Day 1 to Day 28
Time to Resolution of Fever in Participants With Fever at Baseline	Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (<65 years, >=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).	Day 1 to Day 28
Mean Change From Baseline on the National Early Warning Score (NEWS)	The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.	Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14
Time to Definitive Extubation	Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.	Day 1 to Day 28
Time to Independence From Non-Invasive Mechanical Ventilation	Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.	Day 1 to Day 28
Time to Independence From Oxygen Therapy in Days	Time to independence from oxygen therapy in days.	Day 1 to Day 28
Number of Days With Supplemental Oxygen Use	Number of days with supplemental oxygen use.	Day 1 to Day 28
Number of Days of Resting Respiratory Rate <24 Breaths Per Minute	Number of days of resting respiratory rate <24 breaths per minute.	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet Respir Med. 2022 Feb 11;:
• 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. Erratum In: Lancet Respir Med. 2021 Oct;9(10):e102.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: safety; coronavirus; coronavirus infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 17830; I4V-MC-KHAA (Other Identifier: Eli Lilly and Company); 2020-001517-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
• IPD Sharing 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
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No