Status:
SUSPENDED
Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia
Lead Sponsor:
SolAeroMed Inc.
Conditions:
Covid19
SARS-CoV-2 Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 C...
Detailed Description
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 with moderate severity COVID-19...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04738136
Start Date
September 15 2021
End Date
December 31 2021
Last Update
August 23 2021
Active Locations (1)
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1
Alberta Lung Function
Calgary, Alberta, Canada