Phase
Condition
Covid-19
Treatment
Placebo
Baricitinib 4 MG
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Obtain a signed and dated informed consent form from participant
State their willingness to comply with all study procedures and availability for theduration of the study
Male or female, aged ≥18 years old
Meet the following criteria for "Post-COVID Condition" or Long COVID:
6-months prior, documented SARS-CoV-2 infection
Cognitive impairment as defined by having at least 20% positive (worse or muchworse) items on the ECOG assessment
Neurocognitive symptoms must have been present for at least 60 days prior toscreening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening.
Ability to take oral medication and be willing to adhere to the baricitinib regimen
Females of childbearing potential must agree to either abstinence or use at leastone acceptable method of contraception from the time of screening though at least 28days after the end of the study intervention period. Note: Acceptable methodsinclude barrier contraceptives (condoms or diaphragm) with spermicide, intrauterinedevices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgicalsterilization.
Exclusion
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Pre-existing cognitive impairment not exacerbated by acute COVID as determined bystudy physicians after thorough review of participant's history and medical records
Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs)
Known allergic reactions to components of the baricitinib
Have ever been randomized in this study or any other study investigating baricitinib
Positive SARS-CoV-2 PCR or rapid Antigen test in the past 14 days
Pregnancy or breastfeeding
Any history of venous thromboembolism ever
History of malignancy or lymphoproliferative disorder
Renal dysfunction with estimated glomerular filtration rate of < 30 mL/min/1.73m2
Absolute Neutrophil Count (ANC) <1200 cells/mm3
History or evidence of severe or end-stage liver disease (e.g. bilirubin ≥1.5x orAST/ALT >2x normal).
Positive Hepatitis B surface antibody, antigen or core antibody, or PositiveHepatitis C RNR or antigen
Positive HIV 4th generation (antibody/antigen) ELISA test
Have had symptomatic herpes zoster infection within 3 months prior to study entry orhave a history of disseminated/complicated herpes zoster or herpes simplex infection
History of latent (diagnosed with Quantiferon testing) or active tuberculosis
History of a current or recent (< 30 days from screening) clinically significantviral, bacterial, fungal, or parasitic infection
History of chronic alcohol abuse, Intravenous (IV) drug abuse, or other illicit drugabuse within the 2 years prior to study entry
Are immunocompromised and, in the opinion of the investigator, are at anunacceptable risk for participating in the study
Treatment with another investigational drug or other intervention < 30 days of studyenrollment
Are unable or unwilling to make themselves available for the duration of the studyand/or are unwilling to follow study restrictions/procedures
Severe cognitive, physical, or psychological disability that would preventparticipation in the study
Study Design
Study Description
Connect with a study center
University of California San Francisco
San Francisco, California 30329
United StatesSite Not Available
Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
Emory University
Atlanta, Georgia 30329
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232-8300
United StatesSite Not Available
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