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

Trial Summary

What is the purpose of this trial?

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).

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.

Eligibility Criteria

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 have been diagnosed with long COVID as per WHO guidelines.

I am willing and able to follow all study requirements.

Timeline

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

Treatment Details

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.

Participant Groups

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