Clinical trial NCT04590547: GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Official title: Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonitis
SARS-CoV Infection
Keywords: COVID-19
Lead sponsor: GeneOne Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Serious Adverse Events Relative to Treatment Group
timeFrame: 28 days
measure: Number of Treatment Failures at Day 28 From Enrollment
timeFrame: 28 days
Secondary outcomes:
measure: Assess the Number of Days of Hospitalization Relative to Treatment Group
timeFrame: 28 days
measure: Assess the Number of Days Requiring ICU Care Relative to Treatment Group
timeFrame: 28 days
measure: Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
timeFrame: 28 days
measure: Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
timeFrame: 28 days
measure: Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
timeFrame: 28 days
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Kozloduy
country: Bulgaria
facility: MHAT Kozlodui
city: Ruse
country: Bulgaria
facility: SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
city: Ruse
country: Bulgaria
facility: UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
city: Sliven
country: Bulgaria
facility: Military MHAT Sliven
city: Sofia
country: Bulgaria
facility: UHAT Aleksandrovska
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Skopje
country: North Macedonia
facility: PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
city: Skopje
country: North Macedonia
facility: PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
city: Skopje
country: North Macedonia
facility: PHI University Clinic for Pulmonology and Allergology
city: Skopje
country: North Macedonia
facility: PHI University Clinic of Infectious Diseases and Febrile Conditions
city: Struga
country: North Macedonia
facility: PHI General Hospital Struga bb, Quay "8-mi Noemvri"
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
References: