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SPI-1005 Treatment in Severe COVID-19 Patients

Primary Purpose

Covid19, Coronavirus, Coronavirus Infection

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ebselen

Placebo

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

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 14 days, with 30-day follow-up

Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up

Oral administration of matching placebo BID for 14 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

NCT04483973

First Posted

July 13, 2020

Last Updated

October 2, 2023

Sponsor

Sound Pharmaceuticals, Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT04483973

Brief Title

SPI-1005 Treatment in Severe 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 Severe COVID-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 27, 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

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 severe 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, Coronavirus, Coronavirus Infection, Corona Virus 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 14 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 14 days, with 30-day follow-up

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral administration of matching placebo BID for 14 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

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 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.

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

96510

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

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

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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

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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 Severe COVID-19 Patients

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