Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID

Last updated: February 3, 2025
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Pain (Pediatric)

Treatment

Abrocitinib

Placebo

Clinical Study ID

NCT06597396
2024P000700
  • Ages 18-65
  • All Genders

Study Summary

The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning if abrocitinib is effective in improving overall health status in people suffering from severe fatigue from PCC. Eligible participants with a confirmed history of COVID19 infection who also have PCC according to the World Health Organization definition, will be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth daily for 12 weeks (84 days).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of confirmed COVID-19 infection

  • PCC diagnosis according to the WHO definition as occurring in individuals with ahistory of probable or confirmed SARS CoV-2 infection, usually 3 months from theonset of COVID-19 that lasts for at least 2 months and cannot be explained by analternative diagnosis

  • Participants who are willing and able to comply with all scheduled visits, treatmentplan, laboratory tests, lifestyle considerations, and other study procedures

  • Capable of giving signed informed consent

Exclusion

Exclusion Criteria:

  • Participants with acute and chronic infections, history of specific recurrentinfections

  • Suspected or confirmed active SARS-CoV-2 infection within past 30 days

  • Some cardiac conditions

  • Current or former tobacco smoker within the last 12 months

  • Known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, orHepatitis C, Herpes Virus, or Tuberculosis

  • History of immunodeficiency

  • Blood clotting conditions

  • Must meet general screening laboratory criteria

  • Allergy or other contraindication to any of the components of the study intervention

  • Known prior participation in this trial or other trial involving abrocitinib

  • Concurrent therapy with a JAK or TYK2 inhibitor

  • Other protocol criteria apply

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Abrocitinib
Phase: 2
Study Start date:
December 27, 2024
Estimated Completion Date:
June 26, 2026

Study Description

Eligible volunteers will participate in six in-person visits over 4 months. These visits include review of medical and medication history, answering questionnaires, blood, urine, and nasal swab specimen collection, physical exams, and contraceptive and medication counseling.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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