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
This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection. Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily. Clinical status will be monitored through 56 days from the initiation of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
132
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
MHAT Kozlodui
Kozloduy, Bulgaria
Number of Serious Adverse Events Relative to Treatment Group
Time frame: 28 days
Number of Treatment Failures at Day 28 From Enrollment
Time frame: 28 days
Assess the Number of Days of Hospitalization Relative to Treatment Group
Time frame: 28 days
Assess the Number of Days Requiring ICU Care Relative to Treatment Group
Time frame: 28 days
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
Time frame: 28 days
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
Time frame: 28 days
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Time frame: 28 days
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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
...and 7 more locations