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Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06161688
Recruitment Status : Not yet recruiting
First Posted : December 8, 2023
Last Update Posted : December 8, 2023
Sponsor:
Collaborator:
Shionogi Inc.
Information provided by (Responsible Party):
Timothy Henrich, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Long COVID Post Acute Sequelae of COVID-19 Post-Acute COVID-19 Drug: Ensitrelvir Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Randomized Trial of Ensitrelvir (S-217622) for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: Ensitrelvir (S-217622)
Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days
Drug: Ensitrelvir
Those randomized to the experimental arm will receive Ensitrelvir, a protease inhibitor, taken orally for 5 days
Other Name: ensitrelvir fumaric acid

Placebo Comparator: Placebo
Placebo administered orally for 5 days
Other: Placebo
Matching placebo for Ensitrelvir




Primary Outcome Measures :
  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline. [ Time Frame: 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).


Other Outcome Measures:
  1. Patient Global Impression of Change (PGIC) [ Time Frame: At 4 days and 10 days following administration ]
    The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of their treatment. We will use a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health.

  2. Distance walked on 6 minute walk test (6MWT). [ Time Frame: Baseline and 10 days following administration ]
    This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on 6MWT performance between baseline and at 3 months post-administration. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.

  3. Global health score on a 100-point visual-analogue scale [ Time Frame: Baseline and 10 days following administration ]
    This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on self-reported score on a 100-point visual-analogue scale, where 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.

  4. CNS-Vital Signs Global Neurocognitive Index [ Time Frame: Baseline and 10 days following administration ]
    This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on CNS-Vital Signs neurocognitive testing performance between baseline and at 60 days post-administration. CNS-VS is a computerized testing battery that participants will complete at baseline and follow-up visits. The global neurocognitive index is a summary score that comprises multiple domains.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (note, additional eligibility criteria not listed here will be assessed at Screening):

  • ≥18 and <70 years of age at Screening.
  • History of confirmed SARS-CoV-2 infection.
  • Long COVID attributed to a SARS-CoV-2 infection
  • At least two moderate symptoms or one severe symptom that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. Symptoms must have been present for at least 60 days prior to screening and must be reported to be at least somewhat bothersome.
  • Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
  • Participants who are of childbearing potential (CBP) and male participants with sexual partner(s) who are females of CBP must agree to use adequate contraception from study consent through 14 days after the last dose of study intervention.

Exclusion Criteria (note, additional eligibility criteria not listed here will be assessed at Screening):

  • Previously received SARS-CoV-2 antiviral within 90 days prior to planned Day 0 or plan to receive such treatment before exiting the study
  • Previously received COVID-19 convalescent plasma treatment within 60 days prior to planned Day 0 or plan to receive such treatment before exiting the study.
  • Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 60 days prior to Day 0 or before Day 30 following Day 0.
  • Active cardiovascular disease or recent (within 3 months) stroke.
  • Recent (within 6 months) or planned major surgery.
  • Currently hospitalized or recent (within 1 month) unplanned hospitalization.
  • Active Hepatitis B or C infection.
  • Known HIV infection.
  • Severe coagulopathy (international normalized ratio ((INR) >2.0, history of hemophilia).
  • Severe anemia (hemoglobin <9 grams/deciliter (g/dL)).
  • Moderate or severe immunocompromise, according to the current NIH COVID-19 Treatment Guidelines as of March 6, 2023.
  • History of anaphylaxis or hypersensitivity to any components of the intervention, prescription or non-prescription drugs, or food products in the past.
  • Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection
  • Pregnant, breastfeeding, or unwilling to practice birth control abide by the contraception requirements outlined in the inclusion criteria.
  • Participation in a clinical trial with receipt of an investigational product within 28 days prior to Day 0.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06161688


Contacts
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Contact: Michael Peluso, MD (415) 476-4082 x119 Michael.Peluso@ucsf.edu
Contact: Emily Fehrman, MPH (650) 761-2163 Emily.Fehrman2@ucsf.edu

Sponsors and Collaborators
Timothy Henrich
Shionogi Inc.
Investigators
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Principal Investigator: Timothy Henrich, MD University of California, San Francisco
Principal Investigator: Michael Peluso, MD University of California, San Francisco
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Responsible Party: Timothy Henrich, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06161688    
Other Study ID Numbers: 23-38752
First Posted: December 8, 2023    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Timothy Henrich, University of California, San Francisco:
Antiviral
Viral Persistence
Additional relevant MeSH terms:
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COVID-19
Post-Acute COVID-19 Syndrome
Inflammation
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Post-Infectious Disorders
Chronic Disease
Disease Attributes