SPI-1005 Treatment 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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: SPI-1005 400 mg BID
    • Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up
  • Experimental: SPI-1005 800 mg BID
    • Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up
  • Placebo Comparator: Placebo
    • Oral administration of matching placebo BID for 7 days, with 30-day follow-up

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sound Pharmaceuticals, Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Miriam Treggiari, MD, Principal Investigator, Yale University

References

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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