S-217622 plus standard of care (SOC) for Coronavirus

VA Loma Linda Healthcare System (Site 074-017), Loma Linda, CA
CoronavirusShionogi Protease Inhibitor (S-217622) - Drug
All Sexes
What conditions do you have?

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

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

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
proportion of participants who died or required new invasive mechanical ventilation
time to recovery

Trial Safety

Phase-Based Safety

3 of 3
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)
Experimental Group · 1 Intervention: Shionogi Protease Inhibitor (S-217622) · Intervention Types: Drug
placebo plus standard of care (SOC)
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Drug

Trial 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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.