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
Verified date | October 2023 |
Source | Sound Pharmaceuticals, Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sound Pharmaceuticals, Incorporated |
United States,
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
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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