Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID

Phase 2

Recruiting

• Conditions: Post-COVID Condition; Fatigue Symptom
• Interventions: Drug: Abrocitinib; Drug: Placebo

• Registration Number: NCT06597396
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Study Start: 2024-12-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-01-11
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Abrocitinib 50 mg daily	Placebo	Participants will take 50 mg of abrocitinib daily for 12 weeks
Arm 3: Placebo	Placebo	Participants will take placebo daily for 12 weeks
Arm 1: Abrocitinib 50 mg daily	Abrocitinib	Participants will take 50 mg of abrocitinib daily for 12 weeks
Arm 2: Abrocitinib 100 mg once daily	Abrocitinib	Participants will take 100mg of abrocitinib daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale	Baseline to Day 84	To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC

Secondary Outcome Measures

Name	Time	Method
Safety-related clinical laboratory test abnormalities and related adverse events	Baseline to Day 84	To describe the safety and tolerability of abrocitinib compared to placebo in the treatment of PCC in adults with symptomatic PCC
The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84	Baseline to Day 84	To compare the effect of abrocitinib to placebo for the treatment of symptomatic PCC in reducing HSCRP values
Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84	Baseline to Day 84	To compare efficacy of abrocitinib to placebo in improving health status in adults with symptomatic PCC
Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84	Baseline to Day 84	To compare efficacy of abrocitinib to placebo in improving health status adults with symptomatic PCC

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States