NCT06597396Active, not recruitingPhase 2
Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID
A Phase 2a Randomized, Dose Ranging, Double-Blind, 3-Arm Study to Investigate Orally Administered Abrocitinib Compared With Placebo in Non-Hospitalized Symptomatic Adult Participants With Severe Fatigue From Post COVID Condition
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 12 Sept 2024
- Start date
- 27 Dec 2024
- Primary completion date
- 27 Mar 2026
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06597396
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 46
- From 27 Dec 2024 to the primary completion date, 27 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known prior participation in this trial or other trial involving abrocitinib
- Concurrent therapy with a JAK or TYK2 inhibitor
Other illness
- 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
- Known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, Herpes Virus, or Tuberculosis
- History of immunodeficiency
- Blood clotting conditions
- Allergy or other contraindication to any of the components of the study intervention
Lab values
- Must meet general screening laboratory criteria
Age
- Any current tobacco smoker or person who has smoked tobacco products within 12 months of screening, or former tobacco smoker ≥ 50 years old
Other
- Other protocol criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.