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

SARS-CoV Infection Clinical Trial

Official title:

Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04590547
• Other study ID #: GLS27-005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: GeneOne Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 2023
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Pneumonia
• Pneumonitis
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1ß inhibitory activity.
• Placebo
Placebo looks like GLS-1027

Locations

Country	Name	City	State
Bulgaria	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
Korea, Republic of	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
North Macedonia	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
Puerto Rico	University of Puerto Rico	San Juan
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Korea, Republic of,  North Macedonia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events relative to treatment group		28 days
Primary	Incidence of treatment failure at day 28 from enrollment		28 days
Secondary	Assess the number of days of hospitalization relative to treatment group		28 days
Secondary	Assess the number of days requiring ICU care relative to treatment group		28 days
Secondary	Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment		28 days
Secondary	Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group.		28 days
Secondary	Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group		28 days
Secondary	Difference in WHO Classification level at day 28 from enrollment		28 days