AzTrials
AzTrials

Covid19Phase 2NCT04738136

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

A Phase 2 study testing S-1226 in people with Covid19 and SARS-CoV-2 Infection, run by SolAeroMed Inc. at 1 site in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Covid19, SARS-CoV-2 Infection
What is being tested?
S-1226
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
15 Sep 2021to 31 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Alberta Lung Function

    Calgary, Alberta

Other trials in Canada

About this study

Official title: A Randomized, Open-Label, Controlled, Phase II Study to Evaluate the Safety, Tolerability and Efficacy Of S-1226 In Hospitalized Subjects With Moderate Severity Covid-19 Bronchiolitis/Pneumonia

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.

Read the 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 Bronchiolitis/Pneumonia.

S-1226 contains a potent, safe and well-tolerated bronchodilator gas (extrinsic carbon dioxide or CO2) and perflubron (PFOB), a synthetic surfactant that facilitates restoration of surfactant function and mucus clearance. The inhaled S-1226 combination of gas, vapour and liquid aerosol penetrates obstructed airways, resulting in rapid bronchodilation, enhanced blood oxygenation, improved mucus clearance and reduction of work of breathing

The primary objective of this study is to evaluate the safety and tolerability of S-1226 composed of perflubron (PFOB) with ascending doses of carbon dioxide (4%, 8% and 12% CO2) in hospitalized subjects with moderate severity COVID-19 bronchiolitis/pneumonia. The secondary objective is to establish proof of concept that S-1226 is effective in restoring lung function in hospitalized subjects with moderate severity COVID-19 bronchiolitis/pneumonia.

The study will consist of three parts: screening period, Dosing and evaluation, follow up period.

  1. During the screening period, subjects will undergo safety assessments and their eligibility to participate will be confirmed. Eligible subjects will then be randomly assigned to either the treatment arm (S-1226 + Standard of Care arm) or the non-treatment arm (Standard of Care only).
  2. The dosing and evaluation period will take place over 5 days of with two doses per day. Subjects who are randomized to receive S-1226 will be started on a dose level of S-1226 (4%). If tolerated, subjects will progress from 4%, followed by 8%, and then 12%. The highest tolerated dose will then be used for the remainder of the treatment period. All doses incorporate 3mL PFOB and will be administered over a 3-4 minute treatment period. Any enrolled subject randomized to receive S-1226 will not be required to interrupt any SOC treatment which includes supplementary oxygen. Each S-1226 dose will be administered as inhaled gas \& vapour using a Circulaire II hybrid system specifically adapted with the addition of an absolute aerosol filter installed at the site of aerosol generation. This filter removes all perflubron aerosol so that in this trial the S-1226 Gaseous Delivery System delivers an inhaled drug comprising gas (CO2 in air) and vapour (perflubron). In addition, the S-1226 Gaseous Delivery System includes a high efficiency bacterial/viral filter to scavenge any patient-generated exhaled aerosol.
  3. Follow up Period will 28 days after the first dose of S1226 has been administered.
Being tested
S-1226
Keywords
S-1226, Moderate Severity Covid-19 infection, SolAeroMed, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1226Drug

    Also called S1226, CO2 Based intervention

    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

Study groups in NCT04738136
Study groupRoleWhat they receive
Standard of Care (SOC)No interventionSubjects 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% CO2ExperimentalSubjects 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.
Receives: Drug: S-1226

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 28 days

Secondary outcomes (10)

  1. Change in use of supplemental oxygen therapy

    Measured by comparing duration in which supplemental oxygen therapy is used at baseline and after drug administration.

    Measured: up to 28 days

  2. Normalization of body temperature, measured in degrees Celsius.

    This is an exploratory efficacy measure. Assessed by a return to a normal temperature range between 36.1 and 37.2 degrees Celsius for a period of 24 hours.

    Measured: up to 28 days

  3. Evaluation of changes in an SpO2/FiO2 ratio

    This is an exploratory efficacy measure. SpO2/FiO2 ratios of 235 and 315 correlate with PaO2/FiO2 ratios of 200 for Acute Respiratory Distress Syndrome and 300 for Acute Lung Injury.

    Measured: up to 28 days

  4. Mean change on a 7-point ordinal scale

    This is an exploratory efficacy measure. The average change in points from baseline for participants in the study.

    Points 1-7 are defined below:

    1. not hospitalized with resumption of normal activities;
    2. not hospitalized, but unable to resume normal activities;
    3. hospitalized, not requiring supplemental oxygen;
    4. hospitalized, requiring supplemental oxygen;
    5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;
    6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both;
    7. death.

    Measured: up to 28 days

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

    This is an exploratory efficacy measure. Measured by the number of participants that progress from levels 6-7.

    Points 1-7 are defined below:

    1. not hospitalized with resumption of normal activities;
    2. not hospitalized, but unable to resume normal activities;
    3. hospitalized, not requiring supplemental oxygen;
    4. hospitalized, requiring supplemental oxygen;
    5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;
    6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both;
    7. death.

    Measured: up to 28 days

  6. Time to progression to levels 6-7 of the 7-point Ordinal Scale

    This is an exploratory efficacy measure. Measured by the number of days by which a change in participant ordinal score is noted.

    Points 1-7 are defined below:

    1. not hospitalized with resumption of normal activities;
    2. not hospitalized, but unable to resume normal activities;
    3. hospitalized, not requiring supplemental oxygen;
    4. hospitalized, requiring supplemental oxygen;
    5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;
    6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both;
    7. death.

    Measured: up to 28 days

  7. Normalization of oxygen saturation, SpO2 > 90%, while breathing room air, sustained minimum 24 hours

    This is an exploratory efficacy measure. Assessed by evaluations before and after the intervention has been administered.

    Measured: up to 28 days

  8. Time to normalization of oxygen saturation, SpO2 > 90%, while breathing room air sustained minimum 24 hours.

    This is an exploratory efficacy measure. Assessed by the duration required for oxygen saturation, SpO2, to be greater than 90%, while breathing room air and sustained for a minimum of 24 hours, following drug administration.

    Measured: up to 28 days

  9. Change in daily symptom monitoring assessed by yes or no questions to a list of symptoms.

    This is is an exploratory efficacy measure. Assessed by daily evaluations of signs and symptoms before and after the intervention has been administered.

    Measured: up to 6 days

  10. Days of hospitalization attributable to COVID-19 disease

    This is an exploratory efficacy measure. To be assessed by participants discharge date following treatment period.

    Measured: up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start15 Sep 2021 (estimated)
  3. Primary completion31 Oct 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738136
Sponsor's protocol ID
SAMi-05-1-01
Status last verified
Feb 2021
First submitted
27 Jan 2021
Last updated
23 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29914544

  • 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.

    PubMed 27464582

  • 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.

    PubMed 25355286

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-1226 in people with Covid19 and SARS-CoV-2 Infection, run by SolAeroMed Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Emergent Adverse Effects (time frame: up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738136, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in