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Enrolling by invitation NCT04484025

SPI-1005 Treatment in Moderate COVID-19 Patients

Phase II Interventional Covid19 Corona Virus Infection Coronavirus Coronavirus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ebselen, Placebo.
Who it may be relevant to
Registry conditions: Covid19, Corona Virus Infection, Coronavirus, Coronavirus Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Ebselen
    Glutathione peroxidase mimetic
  • Drug Placebo
    Matching placebo containing excipients

Primary outcome measures

  • Number of participants with treatment-related adverse events [Time frame: 30 days]
Secondary outcome measures (3)
  • WHO Ordinal Scale [Time frame: 30 days]
  • Degree of supplemental oxygen [Time frame: 30 days]
  • Peripheral Oxygen Saturation (SpO2) [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Yale University — New Haven
  • St. Luke's Cystic Fibrosis Center of Idaho — Boise
  • Kansas University Medical Center — Kansas City
  • Washington University in St. Louis — St Louis
  • Duke University — Durham
  • Wake Forest University — Winston-Salem
  • University of Texas Southwestern — Dallas

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. PMID 32272481
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT04484025 · SPI-1005-291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗