Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia
Covid19, SARS-CoV-2 Infection
About this trial
This is an interventional treatment trial for Covid19 focused on measuring S-1226, Moderate Severity Covid-19 infection, SolAeroMed, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the following criteria to be included in the study:
- Male or Females between 18-80 years of age at the time of consent.
- Laboratory-confirmed COVID-19 infection
Hospitalized for COVID-19 with clinical evidence of respiratory involvement, including at least one of the following:
- Symptoms/Signs: cough, respiratory distress, increased work of breathing
- Radiology: Chest radiograph or other chest imaging demonstrating one of bronchial thickening, increased secretions, hyperinflation, infiltrates
- Hypoxemia in room air, SpO2 ≤ 90%
Patient belongs to one of the following two categories in the seven-point COVID-19 severity scale:
- Requiring supplemental oxygen by nasal prongs - Level 4 of the seven-point COVID-19 severity scale;
- Requiring nasal high-flow oxygen therapy,- limited to this one component of Level 5 of the seven-point COVID-19 severity scale.
- 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.
- 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:
- Pregnant or breastfeeding females.
- Patients unable to receive S-1226; particularly if receiving oxygen therapy by face mask or non invasive ventilatory support
- Patient requires Extracorporeal Membrane Oxygenation (ECMO) and/or invasive mechanical ventilation
Presence of any of the following abnormal laboratory values at screening:
- Absolute neutrophil count (ANC) less than 0.5 x 109 / L.
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN).
- Platelets less than 50 x109 / L.
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment.
- Subject, who in the opinion of the Investigator, is unsuitable to participate
Sites / Locations
- Alberta Lung Function
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of Care (SOC)
Standard of Care(SOC) + S-1226 at either 4% 8% or 12% CO2
Subjects will only receive standard of care treatment for moderate severity COVID19 bronchiolitis/pneumonia.
Subjects will receive SOC plus the highest tolerated dose of S-1226 at either 4% 8% or 12% CO2 twice daily for up to 5 consecutive days.