The safety and efficacy of STC3141 in patient with COVID-19 Acute Respiratory Distress Syndrome

Phase 2

Withdrawn

• Conditions: COVID-19 infection; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000588998
• Lead Sponsor: Grand Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-21
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Subjects entering the ICU and presenting with confirmed or suspected COVID-19-related ARDS will be enrolled in the trial.
1. Aged 18 to 80 years (inclusive at the time of consent)
2. Subjects are diagnosed with moderate to severe ARDS that has been present for less than 3 days
3. Meet Berlin Definition
1)Must have a partial pressure of arterial O2 (PaO2)/ fraction of inspired O2 (FiO2) less than or equal to 200 mmHg on invasive or non-invasive ventilation with the level of positive end-expiratory pressure (PEEP) or continuous positive pressure (CPAP) greater than or equal to 5cmH2O.
2)Bilateral opacities not fully explained by effusion, lobar or lung collapse, or nodules by chest X-ray or CT
3)Respiratory failure not fully explained by heart failure or fluid overload
In the opinion of the treating clinicians, likely to survive beyond the day after tomorrow.
4. Subjects who are consented

Exclusion Criteria

1. Subjects who have <55 ml/min/BSA
2. Subjects who require ECMO
3. Subjects who require a therapeutic dose of heparin or who are receiving oral
anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours
4. Subjects who have Absolute Neutrophil Count (ANC) <1000/mL;
6. Subjects who have activated Partial Thromboplastin Time (aPTT) >55 s;
7. Severe anaemia (haemoglobin;
8. Bleeding in the past 24 hours requiring blood transfusion;
9. Subjects who have the following chronic organ dysfunction or immunosuppression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in PaO2/FiO2 assessed by arterial blood gases and ventilator measures[end of infusion in stage 2];Incidence, nature and severity of AEs and SAEs[D10 in stage 1];Incidence of treatment discontinuation due to AEs [D10 in stage 1]

Secondary Outcome Measures

Name	Time	Method
ventilator free day to 28 days via medical record [day 28 in stage 2];changes of Sequential organ failure assessment score assessed via SOFA score by investigator[end of infusion in stage 2];changes in Murray Lung Injury Score assessed via Murray LIS by investigator[day 5 in stage 2];changes of lactate assessed via arterial blood gases [EOI, last day in ICU in stage 2];time alive D 28 assessed via medical record[Day 28 in stage 2];time alive and free of ICU assessed via medical record[day 28 in stage 2];time alive and free of hospital assessed via medical record ( it is a composite outcome) [day 28 in stage 2]