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Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID

NCT06161688 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-02

Study results available
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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.

Conditions

  • Long COVID
  • Post Acute Sequelae of COVID-19
  • Post-Acute COVID-19

Interventions

DRUG

Ensitrelvir

Those randomized to the experimental arm will receive Ensitrelvir, a protease inhibitor, taken orally for 5 days

OTHER

Placebo

Matching placebo for Ensitrelvir

Sponsors & Collaborators

  • Shionogi Inc.

    collaborator INDUSTRY

  • Timothy Henrich

    lead OTHER

Principal Investigators

  • Timothy Henrich, MD · University of California, San Francisco

  • Michael Peluso, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2024-12-20
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161688 on ClinicalTrials.gov