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

NCT06597396 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P000700
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Post-COVID Condition; Fatigue Symptom

Keywords

Long COVID; Post-COVID Condition; PCC; Fatigue

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale

  To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC

  Baseline to Day 84

Secondary Outcomes (4)

• Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84

  Baseline to Day 84

• Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84

  Baseline to Day 84

• Safety-related clinical laboratory test abnormalities and related adverse events

  Baseline to Day 84

• The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84

  Baseline to Day 84

Study Arms (3)

Arm 1: Abrocitinib 50 mg daily

EXPERIMENTAL

Participants will take 50 mg of abrocitinib daily for 12 weeks

Drug: Abrocitinib; Drug: Placebo

Arm 2: Abrocitinib 100 mg once daily

EXPERIMENTAL

Participants will take 100mg of abrocitinib daily for 12 weeks

Drug: Abrocitinib

Arm 3: Placebo

PLACEBO COMPARATOR

Participants will take placebo daily for 12 weeks

Drug: Placebo

Interventions

Abrocitinib DRUG

50 mg tablets

Arm 1: Abrocitinib 50 mg daily; Arm 2: Abrocitinib 100 mg once daily

Placebo DRUG

Tablets

Arm 1: Abrocitinib 50 mg daily; Arm 3: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: collaborator
• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Long COVID involves activation of proinflammatory and immune exhaustion pathways

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Virology and Vaccine Research

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: December 27, 2024
• Primary Completion: March 27, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-12

Locations

US (1)