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

April 16, 2026 updated by: Dan Barouch, Beth Israel Deaconess Medical Center

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Abrocitinib 50 mg daily
Participants will take 50 mg of abrocitinib daily for 12 weeks
Drug: Placebo
Tablets
Drug: Abrocitinib
50 mg tablets
Experimental: Arm 2: Abrocitinib 100 mg once daily
Participants will take 100mg of abrocitinib daily for 12 weeks
Drug: Abrocitinib
50 mg tablets
Placebo Comparator: Arm 3: Placebo
Participants will take placebo daily for 12 weeks
Drug: Placebo
Tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2024

Primary Completion (Actual)

March 27, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000700

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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