Status:
ACTIVE_NOT_RECRUITING
Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Post-COVID Condition
Fatigue Symptom
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Eligible volunteers will participate in six in-person visits at Beth Israel Deaconess Medical Center over 5 months. These visits include review of medical and medication history, answering questionnai...
Eligibility Criteria
Inclusion
- 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
- 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
- Any current tobacco smoker or person who has smoked tobacco products within 12 months of screening, or former tobacco smoker ≥ 50 years old
- 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
Key Trial Info
Start Date :
December 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06597396
Start Date
December 27 2024
End Date
September 30 2026
Last Update
December 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215