Clinical trial NCT06597396: Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post-COVID Condition
Fatigue Symptom
Keywords: Long COVID
Post-COVID Condition
PCC
Fatigue
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2024-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale
timeFrame: Baseline to Day 84
Secondary outcomes:
measure: Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84
timeFrame: Baseline to Day 84
measure: Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84
timeFrame: Baseline to Day 84
measure: Safety-related clinical laboratory test abnormalities and related adverse events
timeFrame: Baseline to Day 84
measure: The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84
timeFrame: Baseline to Day 84
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: