Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID

Phase 2

Recruiting

• Conditions: Long COVID; Post Acute Sequelae of COVID-19; Post-Acute COVID-19
• Interventions: Drug: Ensitrelvir; Other: Placebo

• Registration Number: NCT06161688
• Lead Sponsor: Timothy Henrich

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 1:1 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 Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-08
• Study Start: 2024-04-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-03-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ensitrelvir (S-217622)	Ensitrelvir	Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days
Placebo	Placebo	Placebo administered orally for 5 days

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.	Baseline and 10 days following administration	This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the PROMIS-29 scale between baseline and day 30. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do).

Trial Locations

Locations (1)

UCSF/Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States