Status:
ACTIVE_NOT_RECRUITING
Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
Lead Sponsor:
Timothy Henrich
Collaborating Sponsors:
Shionogi Inc.
Conditions:
Long COVID
Post Acute Sequelae of COVID-19
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
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 ...
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 ens...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06161688
Start Date
April 9 2024
End Date
December 31 2025
Last Update
February 10 2025
Active Locations (1)
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1
UCSF/Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110