Abrocitinib for Long COVID Fatigue

(CLEAR-LC Trial)

Overseen By CVVR, Beth Israel Deaconess Medical Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: JAK inhibitors

Disqualifiers: Infections, Cardiac conditions, Smoking, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug abrocitinib can reduce severe fatigue in individuals with Long COVID. Participants will receive either a 50 mg or 100 mg dose of abrocitinib or a placebo (a pill with no active medicine) daily for 12 weeks. The trial aims to determine if abrocitinib can also improve overall health for those experiencing Long COVID fatigue. Individuals who had COVID-19, experience ongoing symptoms like severe tiredness that began at least three months ago, and meet the World Health Organization's criteria for Post-COVID Condition might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on a JAK or TYK2 inhibitor while participating.

Is there any evidence suggesting that abrocitinib is likely to be safe for humans?

Research has shown that abrocitinib has been studied in many patients for other conditions, providing extensive information about its safety. In one study involving 3,802 patients who took abrocitinib for up to four years, the drug's safety remained consistent over time, suggesting it is generally well-tolerated.

However, abrocitinib carries a serious warning about potential risks, including infections, certain types of cancer, major heart and blood vessel problems, and blood clots. These warnings are based on its use in other conditions and are important to consider when thinking about joining a trial.

Participants in this trial will be closely monitored to manage any potential risks. Those considering participation should understand these risks and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Researchers are excited about abrocitinib for Long COVID fatigue because it targets the Janus kinase (JAK) pathway, which is different from most existing treatments that mainly focus on symptom relief rather than addressing underlying inflammation. This mechanism of action offers a new approach by potentially reducing inflammation linked to prolonged COVID-19 symptoms. Additionally, abrocitinib is an oral medication, making it more convenient compared to some treatments that require intravenous administration. This combination of a novel mechanism and easy administration makes abrocitinib a promising candidate for effectively managing Long COVID fatigue.

What evidence suggests that abrocitinib might be an effective treatment for Long COVID fatigue?

Research has shown that abrocitinib helps treat conditions like eczema by reducing inflammation. This is important because Long COVID fatigue might relate to ongoing inflammation in the body. Some studies suggest that abrocitinib could improve symptoms by affecting certain parts of the immune system. In this trial, participants will receive either 50 mg or 100 mg of abrocitinib daily, or a placebo, to evaluate its effects on Long COVID fatigue. Although its effects on Long COVID fatigue are still under investigation, the drug's success in similar conditions offers hope. Early trials in related conditions have shown positive results, prompting its testing for Long COVID fatigue. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who had COVID-19 and now have severe fatigue lasting at least 2 months, as defined by the WHO. They must be able to follow the study's procedures and give informed consent. People with other conditions explaining their symptoms cannot join.

Inclusion Criteria

I have had a confirmed case of COVID-19.

I am willing and able to follow all study requirements.

I can sign and understand the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive abrocitinib or placebo daily for 12 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abrocitinib

Trial Overview The study tests if Abrocitinib can reduce severe fatigue in those with Long COVID compared to a placebo. Participants will randomly receive either Abrocitinib or a placebo daily for 12 weeks to see if there's an improvement in their energy levels and overall health.

How Is the Trial Designed?

Group I: Arm 2: Abrocitinib 100 mg once daily Experimental Treatment 1 Intervention

Participants will take 100mg of abrocitinib daily for 12 weeks

Group II: Arm 1: Abrocitinib 50 mg daily Experimental Treatment 2 Interventions

Participants will take 50 mg of abrocitinib daily for 12 weeks

Group III: Arm 3: Placebo Placebo Group 1 Intervention

Participants will take placebo daily for 12 weeks

Abrocitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Cibinqo for:

• Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Approved in United States as Cibinqo for:

• Refractory, moderate-to-severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06597396

NCT06597396 | Study to Investigate the Efficacy of ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06597396?term=vaccine&cond=COVID&aggFilters=status:rec&viewType=Table&rank=1

Study to Investigate the Efficacy of Abrocitinib in Adult ... 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 ...

3. bidmc.org bidmc.org/-/media/files/long-covid-news-winter-2025.pdf

long-covid-news-winter-2025.pdf Long COVID fatigue: This study will evaluate the effectiveness of Abrocitinib in alleviating severe fatigue caused by Long COVID.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601698/

Clinical Review - Abrocitinib (Cibinqo) - NCBI Bookshelf - NIH Efficacy Results. In the active-controlled, combination-therapy trial (JADE DARE), treatment with abrocitinib 200 mg once daily was superior to dupilumab every ...

5. solvecfs.org solvecfs.org/research/current-clinical-trials-for-me-cfs-long-covid-and-associated-conditions/

Current Clinical Trials for ME/CFS, Long Covid and ... Learn more about current US-based clinical trials recruiting or soon-to-be recruiting for ME/CFS, Long Covid, and associated conditions.

6. cibinqo.pfizerpro.com cibinqo.pfizerpro.com/safety/important-safety-considerations

Important Safety Considerations CIBINQO BOXED WARNING SUMMARY 1. CIBINQO has a BOXED WARNING for serious infections, mortality, malignancies, MACE, and thrombosis. 1

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11193687/

Integrated Safety Update of Abrocitinib in 3802 Patients with ... Overall, this safety analysis of long-term data up to a maximum of ~ 4 years of abrocitinib exposure does not indicate any changes from the ...