SPI-1005 Treatment in Moderate COVID-19 Patients

NCT04484025 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SPI-1005-291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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.

Conditions

Covid19; Corona Virus Infection; Coronavirus; Coronavirus Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events

  30 days

Secondary Outcomes (3)

• WHO Ordinal Scale

  30 days

• Degree of supplemental oxygen

  30 days

• Peripheral Oxygen Saturation (SpO2)

  30 days

Study Arms (3)

SPI-1005 400 mg BID

EXPERIMENTAL

Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up

Drug: Ebselen

SPI-1005 800 mg BID

EXPERIMENTAL

Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up

Drug: Ebselen

Placebo

PLACEBO COMPARATOR

Oral administration of matching placebo BID for 7 days, with 30-day follow-up

Drug: Placebo

Interventions

Ebselen DRUG

Glutathione peroxidase mimetic

Also known as: SPI-1005

SPI-1005 400 mg BID; SPI-1005 800 mg BID

Placebo DRUG

Matching placebo containing excipients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead

Study Sites (7)

Yale University

New Haven, Connecticut, 06510, United States

Location

St. Luke's Cystic Fibrosis Center of Idaho

Boise, Idaho, 83702, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (7)

• 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.

  PMID: 32272481 BACKGROUND

• 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.

  PMID: 32917717 BACKGROUND

• 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.

  PMID: 33574416 BACKGROUND

• 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.

  PMID: 33066278 BACKGROUND

• 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.

  PMID: 33120196 BACKGROUND

• 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.

  PMID: 33855277 BACKGROUND

• 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.

  PMID: 32598985 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

ebselen

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Miriam Treggiari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 23, 2020
• Study Start: October 12, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)