The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,200
Secutrelvir will be administered orally as a tablet.
Placebo will be administered orally as a tablet.
Japanese Site 1
Multiple Locations, Japan
RECRUITINGTime to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 21
Area Under The Curve (AUC) of Change From Baseline in Protocol-defined 14 COVID 19 Symptoms Total Score at Day 8
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Time frame: Baseline, Day 8
Time to First Resolution of Fever Based on Body Temperature
Symptoms will be assessed by the investigator via a participant daily electronic diary.
Time frame: Baseline through Day 28
Time to Sustained Resolution of Fever Based on Body Temperature
Symptoms will be assessed by the investigator via a participant daily electronic diary
Time frame: Baseline through Day 28
Change From Baseline in SARS-CoV-2 Viral RNA Level
Time frame: Baseline through Day 28
Percentage of Participants With All-cause Hospitalization
Time frame: Baseline through Day 21
Percentage of Participants With All-cause Death
Time frame: Baseline through Day 21
Plasma Concentration of Secutrelvir and Its Metabolites
Time frame: Days 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Day 28