COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001244-26/AT

Department of Clinical Pharmacology, Medical University of Vienna, Vienna Austria - Markus Zeitlinger

markus.zeitlinger@meduniwien.ac.at

2020-03-31

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

The study will enrol SARS-Cov-2 positive patients with moderate to severe ARDS admitted to an Intensive Care Unit (ICU) and under mechanical ventilation*. To be eligible to participate in this study, an individual must meet all the following criteria: 1. Informed consent, if possible. 2. Male or female ≥18 years of age. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen. 4. Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in Appendix I) and stable in this condition for at least 8 hours. 5. Moderate and severe ARDS diagnosis as defined by the Berlin Definition: Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema) PaO2/FiO2 < 200 mm Hg continuously observed for a period of ≥4hours (≥2 ABG analyses during that time, with the last value obtained shortly prior to randomization), minimum PEEP ≥8 cm H2O 6. Time from intubation to randomization ≤ 96h

1. History of clinically relevant allergies or idiosyncrasies to solnatide. 2. Severe state of septic shock with a Mean Arterial Pressure (MAP) ≤ 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation. 3. An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD). 4. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. In no way are patients to be denied or delayed these procedures to avoid exclusion from the study. 5. Neutrophil count < 0.3 x 10^9/L. 6. Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator. 7. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order 8. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test

2

Department of Clinical Pharmacology, Medical University of Vienna, Vienna Austria

18

None

Austria

Critical disease at enrollment

8: Critical disease at enrollment

40

• Days free of mechanical ventilation (ventilator free days, VFD) within 28 days • Drug-related adverse events (through day 14) • All adverse events through day 28 • All-cause deaths through day 28 • Vital signs daily through day 14 (heart rate, systolic and diastolic blood pressure, and body temperature) • ECG parameters (if available) including heart rate PQ, QRS, QT and QTc intervals through day 7 • Clinical laboratory assessments (haematology, clinical chemistry, blood gases and urine analysis) daily through day 14 • 24-hour fluid balance through day 7 • Hemodynamic parameters: mean arterial pressure, pulmonary blood volume (PBV), cardiac index and cardiac output assessed at screening and daily until end of treatment • Need for vasoactive drugs assessed at screening and daily until end of treatment

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1220, "treatment_name": "Solnatide", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]