The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib toplacebo in improving severe fatigue in non-hospitalized adults with symptomaticPost-COVID Condition (PCC) (also called Long COVID). We are also interested in learningif abrocitinib is effective in improving overall health status in people suffering fromsevere fatigue from PCC. Eligible participants with a confirmed history of COVID19infection who also have PCC according to the World Health Organization definition, willbe randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouthdaily for 12 weeks (84 days).
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.
Drug: Abrocitinib
50 mg tablets
Drug: Placebo
Tablets
Inclusion Criteria:
- History of confirmed COVID-19 infection
- PCC diagnosis according to the WHO definition as occurring in individuals with a
history of probable or confirmed SARS CoV-2 infection, usually 3 months from the
onset of COVID-19 that lasts for at least 2 months and cannot be explained by an
alternative diagnosis
- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures
- Capable of giving signed informed consent
Exclusion Criteria:
- Participants with acute and chronic infections, history of specific recurrent
infections
- 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, or
Hepatitis 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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Investigator: Ai-ris Collier, MD
Contact: 617-735-4610
BIDMC-CVVRTRIALS@bidmc.harvard.edu
CVVR, Beth Israel Deaconess Medical Center
617-735-4610
BIDMC-CVVRTRIALS@bidmc.harvard.edu
Not Provided