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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events
Secondary outcome measures
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 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
~120

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
1,108 Total Patients Enrolled
1 Trials studying Coronavirus Infection
60 Patients Enrolled for Coronavirus Infection
Haifan Lin, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Coronavirus Infection
60 Patients Enrolled for Coronavirus Infection
Miriam Treggiari, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
522 Total Patients Enrolled
1 Trials studying Coronavirus Infection
60 Patients Enrolled for Coronavirus Infection

Frequently Asked Questions

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

To what extent can Ebselen be detrimental to human health?

"Considering the fact that Ebselen is only in its second phase of clinical trials, our team at Power gauged the medication's safety to be a 2 on the scale from 1-3. Thus far, there are some data points affirming security but none indicating effectiveness."

Answered by AI

How many research centers are actively participating in this trial?

"Currently, 7 medical centres are running the trial; these include Winston-Salem, Dallas and Kansas City as well as other locations. It is suggested that interested participants choose a centre near their residence in order to reduce time spent travelling."

Answered by AI

What is the participant quota for this research endeavor?

"Currently, this medical research is not in the recruitment phase. It was initially published on August 27th 2021 and most recently modified on November 4th 2022. If you are seeking other trials, there are 1,739 studies actively looking for participants with coronavirus infections and an additional four investigation sites admitting patients to study Ebselen's efficacy."

Answered by AI

How does this investigation compare to similar previous research?

"Ebselen has been studied since 2021, beginning with a Phase 1 study sponsored by Sound Pharmaceuticals that included 50 patients. Following successful results from this initial trial, Ebselen was granted its drug approval and currently there are 4 active studies taking place in 23 cities across 2 countries."

Answered by AI

Is it currently possible to register for participation in this investigation?

"As per clinicaltrials.gov, this medical experiment is not currently open for enrollment. The trial was initially posted on August 27th 2021 and last modified on November 4th 2022. While the study isn't welcoming participants presently, there are an abundance of alternative trials with active recruitment campaigns ongoing at present."

Answered by AI

Has Ebselen been tested in other scientific experiments?

"Presently, there are 4 active clinical trials for Ebselen, with 1 study in Phase 3. The bulk of the research is taking place in Durham, North carolina; however, 39 other locations have launched their own experiments into this drug's efficacy."

Answered by AI
Recent research and studies
~17 spots leftby Apr 2025