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

Sponsor
GeneOne Life Science, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04590547
Collaborator
(none)
132
17
3
14.8
7.8
0.5

Study Details

Study Description

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
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

Study Type:
Interventional
Actual 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
Actual Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of serious adverse events relative to treatment group [28 days]

  2. Incidence of treatment failure at day 28 from enrollment [28 days]

Secondary Outcome Measures

  1. Assess the number of days of hospitalization relative to treatment group [28 days]

  2. Assess the number of days requiring ICU care relative to treatment group [28 days]

  3. Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment [28 days]

  4. Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group. [28 days]

  5. Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group [28 days]

  6. Difference in WHO Classification level at day 28 from enrollment [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Baton Rouge General Medical Center Baton Rouge Louisiana United States 70809
2 MHAT Kozlodui Kozloduy Bulgaria
3 SHATPPD d-r Dimitar Gramatikov, Department of Pneumology Ruse Bulgaria
4 UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid Ruse Bulgaria
5 Military MHAT Sliven Sliven Bulgaria
6 UHAT Aleksandrovska Sofia Bulgaria
7 Korea University Ansan Hospital Ansan-si Korea, Republic of
8 Gachon University Gil Medical Center Incheon Korea, Republic of
9 Inha University Hospital Incheon Korea, Republic of
10 Korea University Anam Hospital Seoul Korea, Republic of
11 Korea University Guro Hospital Seoul Korea, Republic of
12 PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions Skopje North Macedonia
13 PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department Skopje North Macedonia
14 PHI University Clinic for Pulmonology and Allergology Skopje North Macedonia
15 PHI University Clinic of Infectious Diseases and Febrile Conditions Skopje North Macedonia
16 PHI General Hospital Struga bb, Quay "8-mi Noemvri" Struga North Macedonia
17 University of Puerto Rico San Juan Puerto Rico 00935

Sponsors and Collaborators

  • GeneOne Life Science, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT04590547
Other Study ID Numbers:
  • GLS27-005
First Posted:
Oct 19, 2020
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022