Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID (NCT06161688) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
United States40 participantsStarted 2024-04-09
Plain-language 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.
Who can participate
Age range18 Years – 69 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score