Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID (CLEAR-LC)

Beth Israel Lahey Health

Status and phase: Enrolling; Phase 2

Conditions: Fatigue Symptom; Post-COVID Condition

Treatments: Drug: Abrocitinib; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06597396

2024P000700

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Arm 1: Abrocitinib 50 mg daily

Experimental group

Description:

Participants will take 50 mg of abrocitinib daily for 12 weeks

Treatment:

Drug: Placebo

Drug: Abrocitinib

Arm 2: Abrocitinib 100 mg once daily

Experimental group

Description:

Participants will take 100mg of abrocitinib daily for 12 weeks

Treatment:

Drug: Abrocitinib

Arm 3: Placebo

Placebo Comparator group

Description:

Participants will take placebo daily for 12 weeks

Treatment:

Drug: Placebo