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Selenium-containing compound
Ebselen for Severe COVID-19
Phase 2
Waitlist Available
Led By Haifan Lin, PhD
Research Sponsored by Sound Pharmaceuticals, Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Summary
This trialtests a potential COVID-19 treatment on adults with severe symptoms, using a randomized, double-blind process.
Who is the study for?
This trial is for adults over 18 with severe COVID-19 symptoms, who've been sick for less than a week and are hospitalized. They must have a positive PCR test for the virus and be able to follow the study rules, including reproductive requirements. People with liver or kidney problems, pregnant or breastfeeding women, or those in other drug studies can't join.
What is being tested?
The trial is testing SPI-1005 (Ebselen), which could help treat severe COVID-19. It's compared against a placebo (a dummy pill). Participants don't know if they're getting the real medicine or the placebo as it's chosen randomly and kept secret.
What are the potential side effects?
While specific side effects of Ebselen aren't listed here, common medication reactions may include nausea, diarrhea, headaches, dizziness or allergic reactions. The severity of these side effects can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Degree of supplemental oxygen
Peripheral Oxygen Saturation (SpO2)
WHO Ordinal Scale
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SPI-1005 800 mg BIDExperimental Treatment1 Intervention
Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up
Group II: SPI-1005 400 mg BIDExperimental Treatment1 Intervention
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Group III: PlaceboPlacebo Group1 Intervention
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ebselen
1999
Completed Phase 3
~380
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Who is running the clinical trial?
Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
1,068 Total Patients Enrolled
Haifan Lin, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
60 Total Patients Enrolled
Miriam Treggiari, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
522 Total Patients Enrolled
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