Safety, Tolerability, Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis caused by SARS-CoV-2 Infection

GeneOne Life Science Inc.0 个研究点目标入组 200 人开始时间: 2021年8月10日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•1.Age 18 years or older
•2.Able to provide informed consent
•3.Able and willing to comply with study procedures
•4.Enrollment within 72 hrs of hospitalization with a diagnosis of PCR confirmed SARS-CoV-2 infection
•5.WHO COVID-19 classification level of 3 or 4
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Pregnant or lactating
•2.SpO2 less than 90% on room air or less than 95% on supplemental oxygen
•3.Calculated GFR < 60 (Cockcroft-Gault)
•4.Meets hospital treatment algorithm for treatment with dexamethasone at a dose of 6 mg/day for a 10 day course. A single bolus dose of 6 mg of dexamethasone given in the Emergency Department and continued at a dose of = 3.5 mg/day or less is allowed.
•5.Meets treatment algorithm criteria for treatment with toclizumab or other anti-IL-6 agent
•6.Treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix A for exclusionary period for individual drugs)
•7.Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
•8.Status-post transplantation of an organ, bone marrow, or body part
•9.Treatment within the past 60 days with a chemotherapeutic agent
•10.Current outpatient treatment with systemic corticosteroids at a dose equivalent of 20 mg/day or greater of prednisone or prednisolone, 16 mg/day or greater of methylprednisolone
•11.Diagnosis of leukemia or lymphoma
•12.WHO COVID-19 classification level of 5 or greater (use of high-flow oxygen, non-mechanical ventilation such as CPAP, mechanical ventilation)
•13.Inability to take oral medications
•14.Grade 3 or greater laboratory abnormalities as characterized by the CTCAE v5

发起方

GeneOne Life Science Inc.