Safety, Tolerability, Efficacy and Dose Response of GLS-1027 in the Prevention of Sever Pneumonitis caused by COVID-19

Phase 1

• Conditions: Patients with SARS-CoV-2 infection; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002730-16-BG
• Lead Sponsor: GeneOne Life Science Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified