Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597396
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID ConditionLong COVID
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR-LC
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
Detailed Description:
Eligible volunteers will participate in six in-person visits over 4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None