Investigating Abrocitinib for Severe Fatigue in 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
This study is testing if a medication called abrocitinib can help adults with Long COVID feel less severe fatigue compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | abrocitinib |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06597396 on ClinicalTrials.gov |
What this trial studies
This phase 2a study aims to evaluate the efficacy of abrocitinib compared to a placebo in alleviating severe fatigue in non-hospitalized adults diagnosed with Post-COVID Condition (PCC), also known as Long COVID. Participants with a confirmed history of COVID-19 will be randomized to receive either abrocitinib at doses of 50 mg or 100 mg, or a placebo, taken daily for 12 weeks. The study includes six in-person visits over four months for medical assessments, specimen collection, and health evaluations to monitor treatment effects and overall health status.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed history of COVID-19 who are experiencing severe fatigue as defined by the World Health Organization.
Not a fit: Patients with active infections, certain cardiac conditions, or those who have smoked tobacco in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from debilitating fatigue due to Long COVID.
How similar studies have performed: While studies on Long COVID are emerging, this specific approach using abrocitinib is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: CVVR, Beth Israel Deaconess Medical Center
- Email: BIDMC-CVVRTRIALS@bidmc.harvard.edu
- Phone: 617-735-4610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.