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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
50 mg tablets
Tablets
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale
To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC
Time frame: Baseline to Day 84
Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84
To compare efficacy of abrocitinib to placebo in improving health status in adults with symptomatic PCC
Time frame: Baseline to Day 84
Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84
To compare efficacy of abrocitinib to placebo in improving health status adults with symptomatic PCC
Time frame: Baseline to Day 84
Safety-related clinical laboratory test abnormalities and related adverse events
To describe the safety and tolerability of abrocitinib compared to placebo in the treatment of PCC in adults with symptomatic PCC
Time frame: Baseline to Day 84
The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84
To compare the effect of abrocitinib to placebo for the treatment of symptomatic PCC in reducing HSCRP values
Time frame: Baseline to Day 84
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