Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161688
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-12-06
Brief Title:
Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
Sponsor:
Timothy Henrich
Organization:
University of California San Francisco
Study Overview
Official Title:
Placebo-Controlled Randomized Trial of Ensitrelvir S-217622 for Viral Persistence and Inflammation in People Experiencing Long COVID PREVAIL-LC
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVAIL-LC
Brief Summary:
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID This mechanism may be susceptible to antiviral therapy that blocks viral replication which has the potential to alleviate long COVID symptoms This trial will study the safety and efficacy of Ensitrelvir S-217622 an antiviral to treat individuals with Long COVID in an adult population
Detailed Description:
The study will enroll approximately 40 participants who meet the World Health Organization WHO Long COVID criteria Participants will be enrolled at a single center and randomized 11 to receive ensitrelvir fumaric acid Ensitrelvir S-217622 given orally for 5 days or placebo Subjects randomized to receive Ensitrelvir will take 375 mg on day 1 followed by 125 mg daily for 4 additional days Evaluations will take place at baseline and at timepoints up to 60 days post-initiation of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None