A Study to Compare S-217622 With Placebo in Non-Hospitalized High-Risk Participants With COVID-19 (SCORPIO-HR)
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|ClinicalTrials.gov Identifier: NCT05305547|
Recruitment Status : Not yet recruiting
First Posted : March 31, 2022
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection||Drug: S-217622 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1729 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, 48-Week Study of the Clinical and Antiviral Effect of S-217622 Compared With Placebo in Non-Hospitalized High-Risk Participants With COVID-19|
|Estimated Study Start Date :||April 30, 2022|
|Estimated Primary Completion Date :||October 13, 2022|
|Estimated Study Completion Date :||August 17, 2023|
S-217622 will be administered orally for 5 days.
Administered as a round tablet.
Placebo Comparator: Placebo
Placebo matching to S-217622 will be administered orally for 5 days.
Administered as a round tablet.
- Composite Outcome: Hospitalization From Any Cause or Death From Any Cause [ Time Frame: Up to Day 29 ]
- Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause [ Time Frame: Up to Day 29 ]
- Percentage of Participants With Nasopharyngeal (NP) SARS-CoV-2 RNA Below the Lower Limit of Quantification (LLoQ) on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
- Median Change From Baseline of SARS-CoV-2 RNA in NP Swabs on Days 4 and 8 [ Time Frame: Baseline, Days 4 and 8 ]
- Percentage of Participants With Undetectable Viral Culture From Nasopharyngeal Samples on Days 4 and 8 [ Time Frame: Days 4 and 8 ]
- Median Time to Sustained Symptom Improvement [ Time Frame: Up to Day 29 ]
- Median Time to Self-reported Return to Usual (Pre-COVID-19) Health [ Time Frame: Up to Day 29 ]
- Percentage of Participants at Each Clinical Status as Assessed by a 7-Point Ordinal Scale [ Time Frame: Day 29 ]
- Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96% [ Time Frame: Up to Day 29 ]
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 48 ]
- Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score [ Time Frame: Baseline, Week 48 ]
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [ Time Frame: Baseline, Week 48 ]
- Change From Baseline in Pose-acute COVID-19 Questionnaire [ Time Frame: Baseline, Week 48 ]
- Percentage of Participants Who Experienced Death Due to Any Cause [ Time Frame: Up to Week 48 ]
- Plasma Concentration of S-217622 [ Time Frame: 60 and 90 minutes postdose on Day 1 and predose on Day 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305547
|Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line||1-800-849-9707||Shionogiclintrialsemail@example.com|