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NCT Number: NCT06597396

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post-COVID Condition COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Fatigue Symptom Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abrocitinib

Drug

50 mg tablets

Placebo

Drug

Tablets

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Acronym: CLEAR-LC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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