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

NCT04738136 | Suspended Phase 2 DMC

• 1 other identifier: SAMi-05-1-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Covid19; SARS-CoV-2 Infection

Keywords

S-1226; Moderate Severity Covid-19 infection; SolAeroMed; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Effects

  The number and percent of treatment emergent adverse events will be monitored, recorded and graded for severity and assigned attribution. The severity will be assessed in the following manner: Mild: Awareness of signs or symptoms, but are easily tolerated and are of minor irritant type, causing no limitations of usual activities. Signs or symptoms may require minor action or additional therapy. Moderate: Discomfort severe enough to cause some limitations of usual activities and may require action or additional therapy. Severe: Incapacitating with inability to carry out usual activities and requires specific action and/or medical attention. Note: the term severe is not the same as "serious", which is based on subject/event outcome or action criteria usually associated with events that pose a threat to a subject's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.

  up to 28 days

Secondary Outcomes (10)

• Change in use of supplemental oxygen therapy

  up to 28 days

• Normalization of body temperature, measured in degrees Celsius.

  up to 28 days

• Evaluation of changes in an SpO2/FiO2 ratio

  up to 28 days

• Mean change on a 7-point ordinal scale

  up to 28 days

• Proportion of patients that progress to levels 6-7 of the 7-point Ordinal Scale

  up to 28 days

Other Outcomes (3)

• Improvement in Thoracic Imaging as assessed by a Radiologist

  up to 28 days

• Number of Participants that develop of secondary pneumonia.

  up to 28 days

• Viral load

  up to 28 days

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

Subjects will only receive standard of care treatment for moderate severity COVID19 bronchiolitis/pneumonia.

Standard of Care(SOC) + S-1226 at either 4% 8% or 12% CO2

EXPERIMENTAL

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.

Drug: S-1226

Interventions

S-1226 DRUG

S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) delivered in vapour form within a medical gas mixture containing CO2. The PFOB component remains the same but the medical gas component contains 4%, 8%, or 12% CO2

Also known as: S1226, CO2 Based intervention

Standard of Care(SOC) + S-1226 at either 4% 8% or 12% CO2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SolAeroMed Inc.: lead

Study Sites (1)

Alberta Lung Function

Calgary, Alberta, Canada

Location

Related Publications (3)

• Swystun V, Green FHY, Dennis JH, Rampakakis E, Lalli G, Fadayomi M, Chiu A, Shrestha G, El Shahat SG, Nelson DE, El Mays TY, Pieron CA, Leigh R. A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma. Trials. 2018 Jun 18;19(1):321. doi: 10.1186/s13063-018-2720-6.

  PMID: 29914544 BACKGROUND

• Green FH, Leigh R, Fadayomi M, Lalli G, Chiu A, Shrestha G, ElShahat SG, Nelson DE, El Mays TY, Pieron CA, Dennis JH. A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers. Trials. 2016 Jul 28;17:361. doi: 10.1186/s13063-016-1489-8.

  PMID: 27464582 BACKGROUND

• El Mays TY, Choudhury P, Leigh R, Koumoundouros E, Van der Velden J, Shrestha G, Pieron CA, Dennis JH, Green FH, Snibson KJ. Nebulized perflubron and carbon dioxide rapidly dilate constricted airways in an ovine model of allergic asthma. Respir Res. 2014 Sep 16;15(1):98. doi: 10.1186/s12931-014-0098-x.

  PMID: 25355286 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

perfluorooctylbromide and CO2 drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mark Montgomery, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 4, 2021
• Study Start: September 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)