MedDataX Logo

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

NCT ID: NCT06597396

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-27

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-COVID Condition Fatigue Symptom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Abrocitinib 50 mg daily

Participants will take 50 mg of abrocitinib daily for 12 weeks

Group Type EXPERIMENTAL

Abrocitinib

Intervention Type DRUG

50 mg tablets

Placebo

Intervention Type DRUG

Tablets

Arm 2: Abrocitinib 100 mg once daily

Participants will take 100mg of abrocitinib daily for 12 weeks

Group Type EXPERIMENTAL

Abrocitinib

Intervention Type DRUG

50 mg tablets

Arm 3: Placebo

Participants will take placebo daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abrocitinib

50 mg tablets

Intervention Type DRUG

Placebo

Tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dan Barouch

Director of the Center for Virology and Vaccine Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.nature.com/articles/s41590-025-02353-x

Long COVID involves activation of proinflammatory and immune exhaustion pathways

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024P000700

Identifier Type: -

Identifier Source: org_study_id