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
| Registry | NCT06597396, acronym CLEAR-LC |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 46 (Actual) |
| Sponsor | Beth Israel Deaconess Medical Center (Other); collaborators: Pfizer |
| Conditions | Post-COVID Condition, Fatigue Symptom |
| Interventions | Abrocitinib, Placebo (Drug) |
| Dates | start 2024-12-27, primary completion 2026-03-27, completion 2026-09-30 (estimated), first posted 2024-09-19, last updated 2026-04-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Post-COVID Condition All trials for Fatigue Symptom All trials of Abrocitinib All trials of Placebo
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).
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 questionnaires, blood, urine, and nasal swab specimen collection, physical exams, and contraceptive and medication counseling.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1: Abrocitinib 50 mg daily | Experimental | Drug: Abrocitinib; Drug: Placebo | Participants will take 50 mg of abrocitinib daily for 12 weeks |
| Arm 2: Abrocitinib 100 mg once daily | Experimental | Drug: Abrocitinib | Participants will take 100mg of abrocitinib daily for 12 weeks |
| Arm 3: Placebo | Placebo comparator | Drug: Placebo | Participants will take placebo daily for 12 weeks |
Sex: All, ages: 18 Years to 65 Years
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 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts | United States |