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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Blood triglycerides increased

100%

80%

60%

40%

20%

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

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor

12 Previous Clinical Trials

1,108 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

Frequently Asked Questions

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

Is this particular trial pioneering a unique methodology?

"Currently, there are 4 live studies for the drug ebselen being conducted across 23 cities in 2 nations. The inaugural trial sponsored by Sound Pharmaceuticals, Incorporated commenced in 2021 and involved 50 participants; it successfully passed its Phase 1 examination period. Subsequently, a total of 18328 trials have been completed since that time."

Answered by AI

Has Ebselen attained governmental authorization for use?

"Ebselen has been assigned a safety score of 2 as it is now in its second phase, though efficacy data is still pending."

Answered by AI

How many venues have approved this clinical investigation?

"At present, this trial has 7 separate sites enrolling patients. These locations are in Durham, Saint Louis and Winston-Salem as well as four other cities, so it is important for potential participants to select the site closest to them if they decide to join."

Answered by AI

Is this experiment currently recruiting participants?

"According to clinicaltrials.gov, the participant recruitment stage of this study has been completed; the trial was initially posted on October 12th 2021 and last updated November 4th 2022. Despite its conclusion, there are still 1,743 similar studies that require volunteers at present."

Answered by AI

What is the full scope of participation in this investigation?

"Unfortunately, this trial has ceased patient recruitment. It was added to the clinicaltrials.gov database on October 12th 2021 and last updated November 4th 20202. However there are 1739 trials that are still open for coronavirus patients as well as four studies utilizing Ebselen seeking volunteers."

Answered by AI

Has the efficacy of Ebselen been researched extensively in any prior clinical studies?

"Ebselen was initially studied in 2021 at Warneford Hospital's Neurosciences Building Dept. of Psychiatry, with a total of 18,328 completed studies since then. There are currently 4 ongoing trials occurring primarily out of Durham, North carolina."

Answered by AI

Recent research and studies

Scientific ReportsJournal

Identification of Ebselen and Its Analogues as Potent Covalent Inhibitors of Papain-like Protease from Sars-cov-2

Weglarz-Tomczak, Ewelina, Jakub M. Tomczak, Michał Talma, Małgorzata Burda-Grabowska, Mirosław Giurg, and Stanley Brul. 2021. “Identification of Ebselen and Its Analogues as Potent Covalent Inhibitors of Papain-like Protease from Sars-cov-2”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-021-83229-6.

Free Radical Biology and MedicineJournal

Potential Therapeutic Use of Ebselen for COVID-19 and Other Respiratory Viral Infections

Sies, Helmut, and Michael J. Parnham. 2020. “Potential Therapeutic Use of Ebselen for COVID-19 and Other Respiratory Viral Infections”. Free Radical Biology and Medicine. Elsevier BV. doi:10.1016/j.freeradbiomed.2020.06.032.

NatureJournal

Structure of Mpro from Sars-cov-2 and Discovery of Its Inhibitors

Jin, Zhenming, Xiaoyu Du, Yechun Xu, Yongqiang Deng, Meiqin Liu, Yao Zhao, Bing Zhang, et al.. 2020. “Structure of Mpro from Sars-cov-2 and Discovery of Its Inhibitors”. Nature. Springer Science and Business Media LLC. doi:10.1038/s41586-020-2223-y.

Science AdvancesJournal