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Antiviral

Ensitrelvir for Post-COVID Syndrome (PREVAIL-LC Trial)

Phase 2
Recruiting
Led By Timothy Henrich, MD
Research Sponsored by Timothy Henrich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 and <70 years of age at Screening
History of confirmed SARS-CoV-2 infection
Must not have
Known HIV infection
Active Hepatitis B or C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 days and 10 days following administration
Awards & highlights

Summary

This trial will test a new antiviral drug called Ensitrelvir (S-217622) to see if it can help people with Long COVID. Long COVID may be caused by the virus

Who is the study for?
Adults aged 18-70 with a history of confirmed COVID-19, experiencing Long COVID symptoms for at least 60 days that are moderately to severely bothersome. Participants must not be known to have other causes for their symptoms and should have a BMI between 18 and 50 kg/m2. They must also agree to use contraception if they can bear children.
What is being tested?
The trial is testing Ensitrelvir, an antiviral drug, against a placebo to see if it's safe and effective in treating Long COVID by potentially blocking viral replication that could cause persistent symptoms.
What are the potential side effects?
Specific side effects of Ensitrelvir are not listed here but may include typical antiviral medication reactions such as nausea, headache, fatigue, or allergic reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have had a confirmed case of COVID-19.
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I have long-term symptoms from a past COVID-19 infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I do not have an active Hepatitis B or C infection.
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I have heart disease or had a stroke in the last 3 months.
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I have a severe bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 days and 10 days following administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 days and 10 days following administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.
Other study objectives
CNS-Vital Signs Global Neurocognitive Index
Distance walked on 6 minute walk test (6MWT).
Global health score on a 100-point visual-analogue scale
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ensitrelvir (S-217622)Experimental Treatment1 Intervention
Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered orally for 5 days

Find a Location

Who is running the clinical trial?

Timothy HenrichLead Sponsor
Shionogi Inc.Industry Sponsor
9 Previous Clinical Trials
730 Total Patients Enrolled
Timothy Henrich, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
82 Total Patients Enrolled
~22 spots leftby Mar 2025
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