Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection (NCT05897541) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
United States2,387 participantsStarted 2023-06-09
Plain-language summary
The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction \[RT-PCR\] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19.
Who can participate
SexALL
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Inclusion criteria
✓. Pediatric participants or adult participants (of any age)
✓. The index participant must:
✓. Have at least 1 COVID-19 symptom within 24 hours before the index participant providing informed consent. COVID-19 symptom(s) must be deemed by the investigator as related to the current SARS-CoV-2 infection (not related to preexisting comorbidities) or deemed as preexisting and worsened due to SARS-CoV-2 infection.
✓. Must have positive SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen from a sample collected prior to randomization of the participant
✓. Must have a potential study participant who can participate in the study after onset of COVID-19 symptoms in an index participant
✓. ≥ 12 years of age at the time of signing the informed consent
✓. Has a negative screening for SARS-CoV-2 infection, as determined by SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva).
✓. Has lived in household with index participant and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study
Exclusion criteria
✕. Tested positive for SARS-CoV-2 in the past 6 months.
✕. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
What they're measuring
1
Number of Participants in the Modified Intention-to-treat (mITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset
✕. Known current renal impairment defined as creatinine clearance \< 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
✕. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
✕. Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
✕. Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
✕. Received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study.
✕. Participants who have used any of the following drugs within 14 days prior to enrollment: