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

  • STATUS
    Recruiting
  • End date
    Sep 21, 2022
  • participants needed
    132
  • sponsor
    GeneOne Life Science, Inc.
Updated on 21 April 2022
covid-19

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.

Details
Condition Pneumonitis, SARS-CoV Infection
Treatment Placebo, GLS-1027
Clinical Study IdentifierNCT04590547
SponsorGeneOne Life Science, Inc.
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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
WHO COVID-19 classification level 3 or 4
Enrollment within 72 of hospitalization

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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