Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia

• Status: Suspended
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, controlled, Phase II proof of concept study to evaluate the safety, tolerability and efficacy of S-1226 in which hospitalized subjects (n≤30) with moderate severity COVID-19 Bronchiolitis/Pneumonia will be enrolled. The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily will be assessed subjects in hospitalized subjects with moderate severity COVID-19 Bronchiolitis/Pneumonia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SolAeroMed Inc.

Criteria

Inclusion Criteria:

• Subjects must meet the following criteria to be included in the study:

1. Male or Females between 18-80 years of age at the time of consent.

2. Laboratory-confirmed COVID-19 infection

3. Hospitalized for COVID-19 with clinical evidence of respiratory involvement, including at least one of the following:

1. Symptoms/Signs: cough, respiratory distress, increased work of breathing

2. Radiology: Chest radiograph or other chest imaging demonstrating one of bronchial thickening, increased secretions, hyperinflation, infiltrates

4. Hypoxemia in room air, SpO2 ≤ 90%

5. Patient belongs to one of the following two categories in the seven-point COVID-19 severity scale:

1. Requiring supplemental oxygen by nasal prongs - Level 4 of the seven-point COVID-19 severity scale;

2. Requiring nasal high-flow oxygen therapy,- limited to this one component of Level 5 of the seven-point COVID-19 severity scale.

6. For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during the study period.

7. Ability to sign informed consent or, when patient is not capable of doing so, informed consent can be signed by legal/authorized representative

Exclusion Criteria:

• Subjects to whom any of the following applies will be excluded from the study:

1. Pregnant or breastfeeding females.

2. Patients unable to receive S-1226; particularly if receiving oxygen therapy by face mask or non invasive ventilatory support

3. Patient requires Extracorporeal Membrane Oxygenation (ECMO) and/or invasive mechanical ventilation

4. Presence of any of the following abnormal laboratory values at screening:

1. Absolute neutrophil count (ANC) less than 0.5 x 109 / L.

2. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN).

3. Platelets less than 50 x109 / L.

5. In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment.

6. Subject, who in the opinion of the Investigator, is unsuitable to participate