Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2021-08-27
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen
Glutathione peroxidase mimetic
SPI-1005 800 mg BID
Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up
Ebselen
Glutathione peroxidase mimetic
Placebo
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo
Matching placebo containing excipients
Interventions
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Ebselen
Glutathione peroxidase mimetic
Placebo
Matching placebo containing excipients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
* Clinical signs, symptoms, and respiratory status consistent with severe COVID-19
* Score of 5-7 on the WHO Ordinal Scale
* Onset of severe COVID-19 symptoms ≤7 days of study enrollment
* Subject is in-patient at time of randomization to study treatment
* Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements
Exclusion Criteria
* Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent.
* Patients with impaired hepatic or renal function.
* Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.
18 Years
ALL
No
Sponsors
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Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Miriam Treggiari, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Washington University in St. Louis
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
Countries
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References
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Jin Z, Du X, Xu Y, Deng Y, Liu M, Zhao Y, Zhang B, Li X, Zhang L, Peng C, Duan Y, Yu J, Wang L, Yang K, Liu F, Jiang R, Yang X, You T, Liu X, Yang X, Bai F, Liu H, Liu X, Guddat LW, Xu W, Xiao G, Qin C, Shi Z, Jiang H, Rao Z, Yang H. Structure of Mpro from SARS-CoV-2 and discovery of its inhibitors. Nature. 2020 Jun;582(7811):289-293. doi: 10.1038/s41586-020-2223-y. Epub 2020 Apr 9.
Menendez CA, Bylehn F, Perez-Lemus GR, Alvarado W, de Pablo JJ. Molecular characterization of ebselen binding activity to SARS-CoV-2 main protease. Sci Adv. 2020 Sep 11;6(37):eabd0345. doi: 10.1126/sciadv.abd0345. Print 2020 Sep.
Weglarz-Tomczak E, Tomczak JM, Talma M, Burda-Grabowska M, Giurg M, Brul S. Identification of ebselen and its analogues as potent covalent inhibitors of papain-like protease from SARS-CoV-2. Sci Rep. 2021 Feb 11;11(1):3640. doi: 10.1038/s41598-021-83229-6.
Brown AS, Ackerley DF, Calcott MJ. High-Throughput Screening for Inhibitors of the SARS-CoV-2 Protease Using a FRET-Biosensor. Molecules. 2020 Oct 13;25(20):4666. doi: 10.3390/molecules25204666.
Haritha CV, Sharun K, Jose B. Ebselen, a new candidate therapeutic against SARS-CoV-2. Int J Surg. 2020 Dec;84:53-56. doi: 10.1016/j.ijsu.2020.10.018. Epub 2020 Oct 23. No abstract available.
Chen T, Fei CY, Chen YP, Sargsyan K, Chang CP, Yuan HS, Lim C. Synergistic Inhibition of SARS-CoV-2 Replication Using Disulfiram/Ebselen and Remdesivir. ACS Pharmacol Transl Sci. 2021 Mar 26;4(2):898-907. doi: 10.1021/acsptsci.1c00022. eCollection 2021 Apr 9.
Sies H, Parnham MJ. Potential therapeutic use of ebselen for COVID-19 and other respiratory viral infections. Free Radic Biol Med. 2020 Aug 20;156:107-112. doi: 10.1016/j.freeradbiomed.2020.06.032. Epub 2020 Jun 26.
Other Identifiers
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SPI-1005-292
Identifier Type: -
Identifier Source: org_study_id
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