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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590547
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Pneumonitis SARS-CoV Infection Drug: GLS-1027 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GLS-1027 120 mg
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
 Drug: GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Experimental: GLS-1027 360 mg
Three 120 mg pills of GLS-1027 given by mouth once daily
 Drug: GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Placebo Comparator: Placebo
Three Placebo pills given by mouth once daily
 Drug: Placebo
Placebo looks like GLS-1027


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of serious adverse events relative to treatment group [ Time Frame: 28 days ]
  2. Incidence of treatment failure at day 28 from enrollment [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Assess the number of days of hospitalization relative to treatment group [ Time Frame: 28 days ]
  2. Assess the number of days requiring ICU care relative to treatment group [ Time Frame: 28 days ]
  3. Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment [ Time Frame: 28 days ]
  4. Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group. [ Time Frame: 28 days ]
  5. Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group [ Time Frame: 28 days ]
  6. Difference in WHO Classification level at day 28 from enrollment [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590547


Contacts
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Contact: Medical Monitor 610-707-5671 jmaslow@genels.us
Contact: Project Manager dkane@genels.us

Locations
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United States, Louisiana
Baton Rouge General Medical Center Active, not recruiting
Baton Rouge, Louisiana, United States, 70809
Bulgaria
MHAT Kozlodui Not yet recruiting
Kozloduy, Bulgaria
Contact: Diana Krastanova-Balkova         
Principal Investigator: Rumen Tiholov         
SHATPPD d-r Dimitar Gramatikov, Department of Pneumology Not yet recruiting
Ruse, Bulgaria
Contact: Vera Cvetinov         
Principal Investigator: Hristo Metev         
UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid Not yet recruiting
Ruse, Bulgaria
Contact: Gloriya Toncheva         
Principal Investigator: Dora Marinova         
Military MHAT Sliven Not yet recruiting
Sliven, Bulgaria
Contact: Petar Andonov         
Principal Investigator: Ilyan Dimitrov Komitov         
UHAT Aleksandrovska Not yet recruiting
Sofia, Bulgaria
Contact: Olga Shoprtko         
Principal Investigator: Atanas Temelkov         
North Macedonia
PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions Recruiting
Skopje, North Macedonia
Contact: Dragica Timova         
Principal Investigator: Dijana Shishkova Gajdardziska         
PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department Recruiting
Skopje, North Macedonia
Contact: Maja Duganovska         
Principal Investigator: Daniela Buklioska Ilievska         
PHI University Clinic for Pulmonology and Allergology Recruiting
Skopje, North Macedonia
Contact: Dimitar Karkinski         
Principal Investigator: Dejan Dokic         
PHI University Clinic of Infectious Diseases and Febrile Conditions Recruiting
Skopje, North Macedonia
Contact: Ilir Demiri         
Principal Investigator: Milena Stevanovikj         
PHI General Hospital Struga bb, Quay "8-mi Noemvri" Recruiting
Struga, North Macedonia
Contact: Xhumkar Shpendi         
Principal Investigator: Mira Kostojchinoska         
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00935
Contact: Sylvia Davila Neves    787-767-9192    sylvia.davila1@upr.edu   
Principal Investigator: Jorge Santana Bagur         
Sponsors and Collaborators
GeneOne Life Science, Inc.
More Information
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Responsible Party: GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier: NCT04590547    
Other Study ID Numbers: GLS27-005
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeneOne Life Science, Inc.:
COVID-19
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Pneumonia
Severe Acute Respiratory Syndrome
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
 Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases