Study Summary
This trial will evaluate a drug, S-217622, to treat COVID-19 inpatients to improve outcomes when given in addition to existing treatments.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 60 days post-treatment
60 days post-intervention
Days to Recovery Scale assessed over 60 days (DRS-60)
60 days post-treatment
a 3-category ordinal outcome
mortality
proportion of participants who died or required new invasive mechanical ventilation
time to recovery
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2 Treatment Groups
S-217622 plus standard of care (SOC)
1 of 2
placebo plus standard of care (SOC)
1 of 2
Experimental Treatment
Non-Treatment Group
1500 Total Participants · 2 Treatment Groups
Primary Treatment: S-217622 plus standard of care (SOC) · Has Placebo Group · Phase 3
S-217622 plus standard of care (SOC)
Drug
Experimental Group · 1 Intervention: Shionogi Protease Inhibitor (S-217622) · Intervention Types: Drugplacebo plus standard of care (SOC)
Drug
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days post-treatment
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,298 Previous Clinical Trials
1,494,900 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,183 Previous Clinical Trials
4,979,398 Total Patients Enrolled
Jens Lundgren, PhDPrincipal InvestigatorUniversity of Copenhagen
1 Previous Clinical Trials
1,500 Total Patients Enrolled
James Neaton, PhDStudy ChairUniversity of Minnesota
7 Previous Clinical Trials
22,993 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
How does the risk profile change for patients when S-217622 is added to their standard of care regimen?
"S-217622 plus standard of care (SOC) is estimated to be a 3 on the Power safety scale." - Anonymous Online Contributor
Unverified Answer