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.
Drug: GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Drug: Placebo
Placebo looks like GLS-1027
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
MHAT Kozlodui
Kozloduy, Bulgaria
SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
Ruse, Bulgaria
UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
Ruse, Bulgaria
Military MHAT Sliven
Sliven, Bulgaria
UHAT Aleksandrovska
Sofia, Bulgaria
Korea University Ansan Hospital
Ansan-si, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
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