E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with SARS-CoV-2 infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084268 |
E.1.2 | Term | COVID-19 |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•Incidence of serious adverse events relative to treatment group •Incidence of treatment failure within 28 days from enrollment
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Age 18 years or older 2.Able to provide informed consent 3.Able and willing to comply with study procedures 4.Enrollment within 72 hrs of hospitalization with a diagnosis of PCR confirmed SARS-CoV-2 infection 5.WHO COVID-19 classification level of 3 or 4
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E.4 | Principal exclusion criteria |
1.Pregnant or lactating 2.SpO2 less than 90% on room air or less than 95% on supplemental oxygen 3.Calculated GFR < 60 (Cockcroft-Gault) 4.Meets hospital treatment algorithm for treatment with dexamethasone at a dose of 6 mg/day for a 10 day course. A single bolus dose of 6 mg of dexamethasone given in the Emergency Department and continued at a dose of ≤ 3.5 mg/day or less is allowed. 5.Meets treatment algorithm criteria for treatment with toclizumab or other anti-IL-6 agent 6.Treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix A for exclusionary period for individual drugs) 7.Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity 8.Status-post transplantation of an organ, bone marrow, or body part 9.Treatment within the past 60 days with a chemotherapeutic agent 10.Current outpatient treatment with systemic corticosteroids at a dose equivalent of 20 mg/day or greater of prednisone or prednisolone, 16 mg/day or greater of methylprednisolone 11.Diagnosis of leukemia or lymphoma 12.WHO COVID-19 classification level of 5 or greater (use of high-flow oxygen, non-mechanical ventilation such as CPAP, mechanical ventilation) 13.Inability to take oral medications 14.Grade 3 or greater laboratory abnormalities as characterized by the CTCAE v5
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is treatment failure which is defined as any subject who achieved WHO level ≥ 6 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please, refer to Schedule of Events per Study Day within the Protocol. |
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E.5.2 | Secondary end point(s) |
•Assess the number of days requiring ICU care relative to treatment group. If a subject does not require ICU care, the number of days will be set to zero for the group summary. The number of ICU days will be summarized for all subjects in each group and for the proportion of those who are actually in ICU. •Assess the number of days of mechanical ventilation relative to treatment group. If a subject does not require mechanical ventilation, the number of days will be set to zero for the group summary. The number of mechanical ventilation days will be summarized for all subjects in each group and for the proportion of those who are actually on mechanical ventilation. •Assess incidence of WHO COVID-19 Classification levels relative to baseline serum IL-6 level •Assess incidence of WHO COVID-19 Classification levels relative to baseline serum ferritin level •Assess incidence of WHO COVID-19 Classification levels relative to baseline CRP •Assess trough level of GLS-1027 relative to serum creatinine •Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group. •Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group •Incidence of progression to WHO COVID-19 Classification level 6, or 7, or 8 (individually) •Assess SARS-CoV-2 IgM antibody responses relative to treatment group
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please, refer to Schedule of Events per Study Day within the Protocol. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |