S-217622 for Coronavirus Disease 2019 (COVID‑19)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Coronavirus Disease 2019 (COVID‑19)+5 More
S-217622 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug against placebo to see if it is effective in treating people with COVID-19 who are not expected to benefit from standard care.

Eligible Conditions
  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 25 Secondary · Reporting Duration: 60 and 90 minutes postdose on Day 1 and predose on Day 4

Day 4
Plasma Concentration of S-217622
Baseline, Day 4
Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4
Day 4
Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Days 4 and 8
Median Change From Baseline of SARS-CoV-2 RNA in NP Swabs on Days 4 and 8
Baseline, Week 24
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
Change From Baseline in Post-Acute COVID-19 Questionnaire
Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score
Baseline, Week 48
Change From Baseline in Pose-acute COVID-19 Questionnaire
Day 29
Percentage of Participants at Each Clinical Status as Assessed by a 7-Point Ordinal Scale
Day 4
Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 4
Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 4 Among Subgroups
Day 8
Percentage of Participants With Detectable SARS-CoV-2 Viral Culture on NP Swab at Day 8
Days 4 and 8
Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8
Percentage of Participants With Nasopharyngeal (NP) SARS-CoV-2 RNA Below the Lower Limit of Quantification (LLoQ) on Days 4 and 8
Percentage of Participants With Undetectable Viral Culture From Nasopharyngeal Samples on Days 4 and 8
Up to Day 29
Composite Outcome: Hospitalization From Any Cause or Death From Any Cause
Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health
Median Time to Self-reported Return to Usual (Pre-COVID-19) Health
Median Time to Sustained Symptom Improvement
Median Time to Sustained Symptom Resolution
Median Time to Sustained Symptom Resolution Among Subgroups
Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause
Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause
Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96%
Up to Week 24
Number of Participants With Adverse Events
Percentage of Participants Who Experienced Death Due to Any Cause
Up to Week 48
Number of Participants With Adverse Events (AEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

S-217622
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

1490 Total Participants · 2 Treatment Groups

Primary Treatment: S-217622 · Has Placebo Group · Phase 3

S-217622
Drug
Experimental Group · 1 Intervention: S-217622 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 and 90 minutes postdose on day 1 and predose on day 4

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,130 Previous Clinical Trials
4,932,574 Total Patients Enrolled
22 Trials studying Coronavirus Disease 2019 (COVID‑19)
89,884 Patients Enrolled for Coronavirus Disease 2019 (COVID‑19)
ShionogiLead Sponsor
107 Previous Clinical Trials
80,371 Total Patients Enrolled
1 Trials studying Coronavirus Disease 2019 (COVID‑19)
54,915 Patients Enrolled for Coronavirus Disease 2019 (COVID‑19)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have shortness of breath or difficulty breathing.
You have diarrhea.
You have nausea.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.