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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04483973
Other study ID # SPI-1005-292
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date August 27, 2021
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source Sound Pharmaceuticals, Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Ebselen
Glutathione peroxidase mimetic
Placebo
Matching placebo containing excipients

Locations

Country Name City State
United States St. Luke's Cystic Fibrosis Center of Idaho Boise Idaho
United States University of Texas Southwestern Dallas Texas
United States Duke University Durham North Carolina
United States Kansas University Medical Center Kansas City Kansas
United States Yale University New Haven Connecticut
United States Washington University in St. Louis Saint Louis Missouri
United States Wake Forest University Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events 30 days
Secondary WHO Ordinal Scale Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome. 30 days
Secondary Degree of supplemental oxygen Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation) 30 days
Secondary Peripheral Oxygen Saturation (SpO2) Peripheral oxygen saturation measured by pulse oximetry 30 days
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