Phase 2
Completed N=132
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Source: ClinicalTrials.gov NCT04590547 ↗Enrolled (actual)
132
Serious AEs
3.0%
Results posted
Apr 2025
Primary outcomePrimary: Number of Serious Adverse Events Relative to Treatment Group — 1; 3; 0 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events Relative to Treatment Group |
1; 3; 0 | — |
| PRIMARY Number of Treatment Failures at Day 28 From Enrollment |
1; 3; 2 | — |
| SECONDARY Assess the Number of Days of Hospitalization Relative to Treatment Group |
9.3; 9.3; 9.4 | — |
| SECONDARY Assess the Number of Days Requiring ICU Care Relative to Treatment Group |
0; 4; 0 | — |
| SECONDARY Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group |
6.7; 7.4; 6.1 | — |
| SECONDARY Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group. |
0; 0; 0 | — |
| SECONDARY Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group |
0; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04590547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.