ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official 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

Quick Facts

Study Start:2024-12-27
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06597396

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of confirmed COVID-19 infection
  2. * 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
  3. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  4. * Capable of giving signed informed consent
  1. * Participants with acute and chronic infections, history of specific recurrent infections
  2. * Suspected or confirmed active SARS-CoV-2 infection within past 30 days
  3. * Some cardiac conditions
  4. * Any current tobacco smoker or person who has smoked tobacco products within 12 months of screening, or former tobacco smoker ≥ 50 years old
  5. * Known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, Herpes Virus, or Tuberculosis
  6. * History of immunodeficiency
  7. * Blood clotting conditions
  8. * Must meet general screening laboratory criteria
  9. * Allergy or other contraindication to any of the components of the study intervention
  10. * Known prior participation in this trial or other trial involving abrocitinib
  11. * Concurrent therapy with a JAK or TYK2 inhibitor
  12. * Other protocol criteria apply

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

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 Registration Dates

Study Start Date2024-12-27
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-12-27
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Long COVID
  • Post-COVID Condition
  • PCC
  • Fatigue

Additional Relevant MeSH Terms

  • Post-COVID Condition
  • Fatigue Symptom