Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Wes Ely
Study ID
NCT06631287
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    4mg encapsulated, pre-formed tablet PO once daily for 24 weeks.
  • Placebo — OTHER
    Matched placebo capsule, PO once daily for 24 weeks.

Study Details

The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.

Key Dates

Start date
Oct 21, 2024
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Janus kinase inhibitor
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

CNS-Vital Signs Global Cognitive Index [ Time Frame: Month 6 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Sairam Parthasarathy, MD
[email protected]
(520) 626-8309
Arianna Bedoya, MPH
[email protected]
(520) 626-1590
University of California, Los Angeles (UCLA)Los AngelesCalifornia90024
Priscilla Y Hsue, MD
[email protected]
Veronica L Schaffer
[email protected]
University of California San FranciscoSan FranciscoCalifornia94143
Michael Peluso, MD
[email protected]
(617) 910-0584
University of Colorado I Anschutz Medical CampusAuroraColorado80045
Sarah Jolley, MD
[email protected]
(303) 724-2902
Jeff McKeehan, MSN, AC-AGNP
[email protected]
(303) 724-6080
Yale UniversityNew HavenConnecticut06510
Basmah Safdar, MD
[email protected]
(475) 306-5688
Anirudh Goyal, MPH
[email protected]
University of Florida College of MedicineGainesvilleFlorida32610
Nicole Iovine, MD, PhD
[email protected]
(352) 273-5481
Alexandra Taylor, MS
[email protected]
(352) 294-4248
Emory UniversityAtlantaGeorgia30322
Vincent Marconi, MD
[email protected]
(404) 727-2343
Illinois Research Network (ILLInet), University of Illinois ChicagoChicagoIllinois60608
Jerry A Krishnan, MD, PhD
[email protected]
(410) 960-1694
Andrea Wendrow, RPh
[email protected]
(312) 413-9588
Brigham and Women's HospitalBostonMassachusetts02115
Lindsey R Baden, MD
[email protected]
6175257327
University of MinnesotaMinneapolisMinnesota55455
Carolyn Bramante, MD, MPH
[email protected]
(651) 717-8915
NYU Langone Health - BrooklynBrooklynNew York11220
Jennifer Frontera, MD
[email protected]
(718) 630-6689
Zariya Alvarez, MPH
[email protected]
(917) 613-5770
The MetroHealth SystemClevelandOhio44109
Nora Singer, MD
[email protected]
(216) 778-3693
Emma Barnboym, BSNs
[email protected]
(216) 778-3752
University Hospitals Cleveland Case WesternClevelandOhio44106
Grace McComsey, MD
(216) 368-3731
Danielle Labbato, BSN, RN
[email protected]
(216) 844-2739
Vanderbilt University MedicalNashvilleTennessee37203
Matthew Mart, MD, MSCI
[email protected]
(615) 322-0184
University of Texas at San AntonioSan AntonioTexas78229
Thmas F Patterson, MD
[email protected]
(210) 567-4810
Barbara S Taylor, MD
[email protected]
(210) 567-4823
Swedish Medical CenterSeattleWashington98104
Jason Goldman, MD, MPH
[email protected]
(206) 386-3660
Allie Duven, BSN
[email protected]
(206) 337-3864
West Virginia Clinical and Translational Science InstituteMorgantownWest Virginia26506-7015
Madison Heltzel (nee Kelley), RN, BSN
[email protected]
(304) 293-6360
Tara Riddle, BA, MSW
[email protected]
(304) 581-1829
Sally Hodder, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

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COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Arizona· Tucson, AZUniversity of California, Los Angeles (UCLA)· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAUniversity of Colorado I Anschutz Medical Campus· Aurora, COYale University· New Haven, CTUniversity of Florida College of Medicine· Gainesville, FL

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