Post-COVID ConditionPhase 2CLEAR-LCNCT06597396
Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID
A Phase 2 study testing Abrocitinib in people with Post-COVID Condition and Fatigue Symptom, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-COVID Condition, Fatigue Symptom
- What is being tested?
- Abrocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2024to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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
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).
Read the detailed description
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
- Post-COVID Condition, Fatigue Symptom
- Being tested
- Abrocitinib, Placebo
- Keywords
- Long COVID, Post-COVID Condition, PCC, Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
50 mg tablets
PlaceboDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Abrocitinib 50 mg daily | Experimental | Participants will take 50 mg of abrocitinib daily for 12 weeks Receives: Drug: Abrocitinib; Drug: Placebo |
| Arm 2: Abrocitinib 100 mg once daily | Experimental | Participants will take 100mg of abrocitinib daily for 12 weeks Receives: Drug: Abrocitinib |
| Arm 3: Placebo | Placebo comparator | Participants will take placebo daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To compare efficacy of abrocitinib to placebo in improving health status in adults with symptomatic PCC
Measured: Baseline to Day 84
Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84
To compare efficacy of abrocitinib to placebo in improving health status adults with symptomatic PCC
Measured: Baseline to Day 84
Safety-related clinical laboratory test abnormalities and related adverse events
To describe the safety and tolerability of abrocitinib compared to placebo in the treatment of PCC in adults with symptomatic PCC
Measured: Baseline to Day 84
The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84
To compare the effect of abrocitinib to placebo for the treatment of symptomatic PCC in reducing HSCRP values
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Dec 2024
- Primary completion27 Mar 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID ConditionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dan Barouch, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597396
- Sponsor's protocol ID
- 2024P000700
- Acronym
- CLEAR-LC
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06597396
- Acronym / sponsor ID
- CLEAR-LC / 2024P000700
- Conditions
- Post-COVID Condition, Fatigue Symptom
- Keywords
- Long COVID, Post-COVID Condition, PCC, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Abrocitinib 50 mg daily | Experimental | Drug: Abrocitinib, Drug: PlaceboParticipants will take 50 mg of abrocitinib daily for 12 weeks |
| Arm 2: Abrocitinib 100 mg once daily | Experimental | Drug: AbrocitinibParticipants will take 100mg of abrocitinib daily for 12 weeks |
| Arm 3: Placebo | Placebo comparator | Drug: PlaceboParticipants will take placebo daily for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abrocitinib50 mg tablets | Drug | Arm 1: Abrocitinib 50 mg daily, Arm 2: Abrocitinib 100 mg once daily |
| PlaceboTablets | Drug | Arm 1: Abrocitinib 50 mg daily, Arm 3: Placebo |
Primary outcome
Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale
Time frame: Baseline to Day 84
To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC
4 secondary outcomes
Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84
Time frame: Baseline to Day 84
Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84
Time frame: Baseline to Day 84
Safety-related clinical laboratory test abnormalities and related adverse events
Time frame: Baseline to Day 84
The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84
Time frame: Baseline to Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Long COVID involves activation of proinflammatory and immune exhaustion pathwaysLink provided by the sponsor.
Related trials for Post-COVID Condition
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
Recruiting
SuperCAP Program to Improve Cognition and Daily Functioning in Post-COVID-19 Condition
Post COVID Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abrocitinib in people with Post-COVID Condition and Fatigue Symptom, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale (time frame: Baseline to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.