COVID-19: Efficacy of solnatide to treat pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS - a pilot-trial.

Phase 1

• Conditions: Pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS; MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10037423Term: Pulmonary oedemaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001244-26-AT
• Lead Sponsor: Department of Clinical Pharmacology, Medical University of Vienna, Vienna Austria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified