SPI-1005 Treatment in Severe COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04483973

Recruitment Status : Enrolling by invitation

First Posted : July 23, 2020

Last Update Posted : October 3, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Sound Pharmaceuticals, Incorporated

Study Description

Brief Summary:

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

Condition or disease	Intervention/treatment	Phase
Covid19 Coronavirus Coronavirus Infection Corona Virus Infection	Drug: Ebselen Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients
Actual Study Start Date :	August 27, 2021
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: SPI-1005 400 mg BID Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up	Drug: Ebselen Glutathione peroxidase mimetic Other Name: SPI-1005
Experimental: SPI-1005 800 mg BID Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up	Drug: Ebselen Glutathione peroxidase mimetic Other Name: SPI-1005
Placebo Comparator: Placebo Oral administration of matching placebo BID for 14 days, with 30-day follow-up	Drug: Placebo Matching placebo containing excipients

Outcome Measures

Primary Outcome Measures :

Number of participants with treatment-related adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :

WHO Ordinal Scale [ Time Frame: 30 days ]
Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Degree of supplemental oxygen [ Time Frame: 30 days ]
Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Peripheral Oxygen Saturation (SpO2) [ Time Frame: 30 days ]
Peripheral oxygen saturation measured by pulse oximetry

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults ≥18 years of age
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:

Female patients who are pregnant or breastfeeding.
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483973

Locations

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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 96510
United States, Idaho
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States, 83702
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Sound Pharmaceuticals, Incorporated

Investigators

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Principal Investigator:	Miriam Treggiari, MD	Yale University

More Information

Publications:

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. Erratum In: ACS Pharmacol Transl Sci. 2021 Apr 29;4(3):1246.

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.

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Responsible Party:	Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier:	NCT04483973
Other Study ID Numbers:	SPI-1005-292
First Posted:	July 23, 2020 Key Record Dates
Last Update Posted:	October 3, 2023
Last Verified:	October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Sound Pharmaceuticals, Incorporated:


ebselen SPI-1005 COVID-19 Covid SARS-COV-2	Mpro main protease PLpro papain-like protease

Additional relevant MeSH terms:

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Infections Communicable Diseases COVID-19 Coronavirus Infections Disease Attributes Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases	Ebselen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Anti-Ulcer Agents Gastrointestinal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Cyclooxygenase Inhibitors

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