Back to resultsSPI-1005 Treatment in Moderate COVID-19 Patients
Primary Purpose
Covid19, Corona Virus Infection, Coronavirus
Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ebselen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring ebselen, SPI-1005, COVID-19, Covid, SARS-COV-2, Mpro, main protease, PLpro, papain-like protease
Eligibility 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 moderate COVID-19
- Score of 3-4 on the WHO Ordinal Scale
- Onset of moderate COVID-19 symptoms ≤3 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.
Sites / Locations
- Yale University
- St. Luke's Cystic Fibrosis Center of Idaho
- Kansas University Medical Center
- Washington University in St. Louis
- Duke University
- Wake Forest University
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SPI-1005 400 mg BID
SPI-1005 800 mg BID
Placebo
Arm Description
Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up
Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up
Oral administration of matching placebo BID for 7 days, with 30-day follow-up
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events
Secondary Outcome Measures
WHO Ordinal Scale
Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Degree of supplemental oxygen
Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation measured by pulse oximetry
Full Information
NCT ID
NCT04484025
First Posted
July 13, 2020
Last Updated
October 2, 2023
Sponsor
Sound Pharmaceuticals, Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT04484025
Brief Title
SPI-1005 Treatment in Moderate COVID-19 Patients
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sound Pharmaceuticals, Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 moderate symptoms of COVID-19 disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corona Virus Infection, Coronavirus, Coronavirus Infection
Keywords
ebselen, SPI-1005, COVID-19, Covid, SARS-COV-2, Mpro, main protease, PLpro, papain-like protease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPI-1005 400 mg BID
Arm Type
Experimental
Arm Description
Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up
Arm Title
SPI-1005 800 mg BID
Arm Type
Experimental
Arm Description
Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration of matching placebo BID for 7 days, with 30-day follow-up
Intervention Type
Drug
Intervention Name(s)
Ebselen
Other Intervention Name(s)
SPI-1005
Intervention Description
Glutathione peroxidase mimetic
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo containing excipients
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
WHO Ordinal Scale
Description
Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Time Frame
30 days
Title
Degree of supplemental oxygen
Description
Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Time Frame
30 days
Title
Peripheral Oxygen Saturation (SpO2)
Description
Peripheral oxygen saturation measured by pulse oximetry
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 moderate COVID-19
Score of 3-4 on the WHO Ordinal Scale
Onset of moderate COVID-19 symptoms ≤3 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Treggiari, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
St. Luke's Cystic Fibrosis Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32272481
Citation
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.
Results Reference
background
PubMed Identifier
32917717
Citation
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.
Results Reference
background
PubMed Identifier
33574416
Citation
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.
Results Reference
background
PubMed Identifier
33066278
Citation
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.
Results Reference
background
PubMed Identifier
33120196
Citation
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.
Results Reference
background
PubMed Identifier
33855277
Citation
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.
Results Reference
background
PubMed Identifier
32598985
Citation
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.
Results Reference
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SPI-1005 Treatment in Moderate COVID-19 Patients
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