GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pneumonitis, SARS-CoV Infection

In brief

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

Key facts

Study ID

NCT04590547

Run by

GeneOne Life Science, Inc.

People needed

132

Starts

2021-05-07

Expected to finish

2023-07-24

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Able to provide consent
• Able and willing to comply with study procedures
• Diagnosis of PCR confirmed SARS-CoV-2
• Enrollment within 72 of hospitalization
• WHO COVID-19 classification level 3 or 4

You may not qualify if…

• Pregnant or lactating
• Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask
• Calculated GFR < 60 (Cockcroft-Gault)
• Meets treatment algorithm criteria for treatment with a non-study immune modulator
• Pre-study or planned treatment with a non-study immune modulator
• Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
• Status post transplantation of an organ, bone marrow, or body part
• Treatment within the past 60 days with a chemotherapeutic agent
• Diagnosis of leukemia or lymphoma
• WHO COVID-19 classification level of 5 or greater
• Unable to take oral medication
• Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5

Where it is running

• Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
• MHAT Kozlodui — Kozloduy, Bulgaria
• SHATPPD d-r Dimitar Gramatikov, Department of Pneumology — Rousse, Bulgaria
• UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid — Rousse, Bulgaria
• Military MHAT Sliven — Sliven, Bulgaria
• UHAT Aleksandrovska — Sofia, Bulgaria
• PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions — Skopje, North Macedonia
• PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department — Skopje, North Macedonia
• PHI University Clinic for Pulmonology and Allergology — Skopje, North Macedonia
• PHI University Clinic of Infectious Diseases and Febrile Conditions — Skopje, North Macedonia
• PHI General Hospital Struga bb, Quay "8-mi Noemvri" — Struga, North Macedonia
• University of Puerto Rico — San Juan, Puerto Rico
• Korea University Ansan Hospital — Ansan-si, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Inha University Hospital — Incheon, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Korea University Guro Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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