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.
This study will enroll 2 types of participants: 1. those with a negative screening SARS-CoV-2 infection (referred to as "study participants"); 2. those with a positive screening SARS-CoV-2-infection (referred to as "index participants"). Study participants will receive study intervention (S-217622 or placebo), index participants will receive no study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,387
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
Time frame: Day 1 through Day 10
Number of Participants in the Intention-to-treat (ITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset
Time frame: Day 1 through Day 10
Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
Time frame: Day 1 through Days 10, 15, or 28
Time to the First Positive RT-PCR Result
Time frame: Day 1 through Day 10
Number of Participants with a Positive RT-PCR Result
Time frame: Day 1 through Day 10
Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms
Time frame: Day 1 through Day 10
Number of Participants with Sustained Resolution of all COVID-19 Symptoms
Time frame: Day 1 through Day 28
Number of Participants with Sustained Resolution of Each COVID-19 Symptom
Time frame: Day 1 through Day 28
Change in Total Score of COVID-19 Symptoms
Time frame: Day 1 through Day 10
Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
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Central Alabama Research
Birmingham, Alabama, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Absolute Clinical Research, LLC
Phoenix, Arizona, United States
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, United States
Healthstar Research
Hot Springs, Arkansas, United States
Preferred Research Partners - ClinEdge - PPDS
Little Rock, Arkansas, United States
Neighborhood Healthcare
Escondido, California, United States
Apex Research Group
Fair Oaks, California, United States
Ascada Research LLC
Fullerton, California, United States
...and 168 more locations
Time frame: Day 1 through Day 28
Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
Time frame: Day 1 through Day 28
Number of Participants Experiencing Hospitalization or Death from Any Cause
Time frame: Day 1 through Day 28
Plasma Concentration of S-217622
Time frame: Day 3, Day 6, and Event Driven
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 28