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. A total of 3701 participants will be enrolled in the study, of whom 2387 will be randomized to receive study drug or placebo, and 1314 will be enrolled as index case participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,701
Number of Participants in mITT Population Who Were Infected With SARS-CoV-2 and Had Coronavirus Disease 2019 (COVID-19) Symptoms Onset
Symptomatic COVID-19 was defined as a central laboratory-confirmed (CLC) positive reverse transcription polymerase chain reaction (RT-PCR) test and the occurrence (or worsening \[increasing a symptom score from baseline\] in the case of preexisting COVID-19-like symptoms) of \>= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Time frame: Day 1 up to Day 10
Number of Participants in ITT Population With a Negative Screening SARS-CoV-2 Infection Who Were Infected With SARS-CoV-2 and Had COVID-19 Symptoms Onset
Symptomatic COVID-19 was defined as a CLC positive RT-PCR test and the occurrence (or worsening \[increasing a symptom score from baseline\] in the case of preexisting COVID-19-like symptoms) of \>= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Time frame: Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
COVID-19 with or without symptoms onset was defined as any post baseline CLC-positive RT-PCR test.
Time frame: Days 10, 15 and 28
Time to the First Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Result
Time frame: Day 1 up to Day 28
Number of Participants With a Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Results
Time frame: Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 With no COVID-19 Symptoms at Day 10
Asymptomatic COVID-19 was defined as: Incident SARS-CoV-2 infection between first study intervention administration and Day 10 visit, as confirmed by CLC positive RT-PCR test, no negative RT-PCR test between (1) the day of the first positive test and (2) Day 10 visit after the first study intervention and no COVID-19 symptoms occurrence on Day 10 (or if Day 10 is missing, no symptoms recorded on the most recent diary entry prior to Day 10).
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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 10
Number of Participants Infected With SARS-CoV-2 and Had no COVID-19 Symptoms Onset Through Day 10
COVID-19 without symptoms onset was defined as any post-baseline CLC positive RT-PCR result through the Day 10 visit (up to day 11), but without any new or worsening symptoms having duration \>=48 hours starting by day 10.
Time frame: Day 1 up to Day 10
Number of Participants With Sustained Symptom Resolution of Each COVID-19 Symptoms
Sustained symptoms resolution was defined as \>=48 hours with each symptom (except loss of taste and loss of smell) having an equal or lower symptom score relative to that symptom's baseline value.
Time frame: Day 1 up to Day 28
Change From Baseline in Total Symptom Score of COVID-19 Symptoms at Day 10
Total symptom score was defined as the sum of scores for all 14 targeted symptoms (each individual symptom score was 0 = none, 1 = mild, 2 = moderate, and 3 = severe), where total score ranged 0 (none)-42 (severe symptom) and higher scores indicated severe symptoms.
Time frame: Baseline, Day 10
Time From First Central Laboratory Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
Time from CLC positive RT-PCR test to time of first symptoms diary reporting at least 1 COVID-19 symptom with greater-than-baseline severity through Day 28 has been reported.
Time frame: Day 1 up to Day 28
Time From First Central Laboratory Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
COVID-19 symptoms onset was defined as the occurrence (or worsening \[increasing a symptom score from baseline\] in the case of preexisting COVID-19-like symptoms) of \>= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Time frame: Day 1 up to Day 28
Number of Participants Experiencing Hospitalization or Death From Any Cause
Hospitalization was defined as \>=24 hours of acute care for any reason, in a hospital or similar acute care facility, including emergency rooms or urgent care clinics. The participants reported below were hospitalized. No participants died in the study.
Time frame: Day 1 up to Day 28
Trough Concentration (Ctrough) of S-217622
Time frame: Day 3
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE was defined as an AE reported after the first dose of study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 up to Day 28