The trial is taking place at:
B

Baton Rouge General Medical Center | Clinical Trials Office

Veeva-enabled site

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

G

GeneOne Life Science

Status and phase

Active, not recruiting
Phase 2

Conditions

Pneumonitis
SARS-CoV Infection

Treatments

Drug: Placebo
Drug: GLS-1027

Study type

Interventional

Funder types

Industry

Identifiers

NCT04590547
GLS27-005

Details and patient eligibility

About

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

Full 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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

132 participants in 3 patient groups, including a placebo group

GLS-1027 120 mg
Experimental group
Description:
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
Treatment:
Drug: GLS-1027
GLS-1027 360 mg
Experimental group
Description:
Three 120 mg pills of GLS-1027 given by mouth once daily
Treatment:
Drug: GLS-1027
Placebo
Placebo Comparator group
Description:
Three Placebo pills given by mouth once daily
Treatment:
Drug: Placebo

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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