SPI-1005 Treatment in Severe COVID-19 Patients

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04483973
• Other study ID #: SPI-1005-292
• Status: Enrolling by invitation
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections

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