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Selenium-containing compound

Ebselen for Moderate 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
Awards & highlights

Summary

This trial is testing a possible new medication for people who have a positive PCR test for the novel coronavirus and moderate symptoms of COVID-19. The study is double-blind, meaning that neither the participants nor the researchers will know who is receiving the medication or the placebo until after the study is completed.

Who is the study for?
This trial is for adults over 18 with moderate COVID-19 symptoms, confirmed by a positive PCR test. They must be in-patients and have had symptoms for ≤3 days before joining the study. Pregnant or breastfeeding women, those with liver/kidney issues, or participation in another drug/device study within 30 days are excluded.
What is being tested?
The trial tests SPI-1005 (Ebselen) against a placebo to see if it helps patients with moderate COVID-19. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment versus placebo until after results are collected.
What are the potential side effects?
While specific side effects of Ebselen (SPI-1005) aren't listed here, common medication-related side effects could include digestive discomfort, headaches, dizziness, or allergic reactions. The severity can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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

Side effects data

From 2019 Phase 2 trial • 149 Patients • NCT03325790
10%
Upper respiratory tract infection
10%
Alanine aminotransferase increased
2%
Blood triglycerides increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
400mg SPI-1005 BID
Placebo
200mg SPI-1005 Twice Daily (BID)

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 7 days, with 30-day follow-up
Group II: SPI-1005 400 mg BIDExperimental Treatment1 Intervention
Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up
Group III: PlaceboPlacebo Group1 Intervention
Oral administration of matching placebo BID for 7 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

Find a Location

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
~15 spots leftby Sep 2025
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