Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms.

NCT04949386 | Unknown Phase 2 DMC

• 1 other identifier: SAMi-06-1-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized (1:1) , placebo-controlled phase II study to evaluate the safety, tolerability and efficacy of S-1226 in Post-COVID-19 subjects (n≤48) with persistent respiratory symptoms. Subjects will receive twice daily treatments of either Placebo or S-1226 (8%) for 7 days.

Conditions

Post Acute COVID-19 Syndrome; Long COVID; COVID-19 Respiratory Infection

Keywords

S-1226; Prolonged post viral respiratory symptoms

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.

  16 days

Secondary Outcomes (3)

• Normalization in 6-minute walk test (6MWT) distance

  16 days

• Changes in percent predicted forced expiratory volume in 1 second

  16 days

• Changes in from baseline in respiratory symptoms assessed by the St George's Respiratory Questionnaire (SGRQ).

  16 days

Other Outcomes (6)

• Change from baseline in Forced Vital Capacity.

  16 days

• Changes from baseline in Diffusing Lung Capacity

  16 days

• Changes from baseline in Oxygen Saturation (SpO2)

  16 days

Study Arms (2)

Treatment with S-1226 (8%)

EXPERIMENTAL

Subjects randomized to this treatment arm will receive S-1226(8%) twice daily for 7 consecutive days. S-1226 will be administered by inhalation for 3-4 minutes.

Drug: S-1226 (8%)

Placebo

PLACEBO COMPARATOR

Subjects randomized to receive placebo will be administered with medical grade air with 3ml saline (0.9% NaCl) using the Circulaire II hybrid system. Placebo will be administered by inhalation for 3-4 minutes.

Other: Placebo

Interventions

S-1226 (8%) DRUG

S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) delivered in gas/aerosol/vapor form within a medical gas mixture containing 8% CO2.

Also known as: S-1226

Treatment with S-1226 (8%)

Placebo OTHER

Placebo will delivered by inhalation of saline (0.9% NaCl) and Medical grade air.

Placebo

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
• Able to provide informed consent.
• Prior confirmed COVID-19 diagnosis by standard Real time Polymerase Chain Reaction (RT-PCR) assay or Immunoglobin M/G (IgM/IgG) rapid serological test at least 4 weeks prior to screening visit.
• Ambulatory patients may be attending COVID long term follow up clinic or discharged from hospital for at least one week.
• Evidence of new and/or persistent respiratory symptoms at least 4 weeks after the onset of acute COVID-19 infection. This will be determined by history of respiratory symptoms: cough, wheeze, limitation of activities.
• Able to perform an exercise of moderate activity e.g., walking up a hill or climbing stairs (required to assess Borg RPE)
• Able to walk unaided for a minimum distance of 10 meters (distance validated for completion of 6-minute walk test)

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Pregnancy or of childbearing age without a highly effective method or at least two forms of effective contraception and/ or abstinence for the duration of study. Highly effective methods of contraception (Contraception with \< 1% failure rate) are: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation. Effective methods of contraception may include barrier methods of contraception (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge).
• Breastfeeding females.
• Evidence of active thromboembolic disorder - defined by those receiving parenteral anticoagulant or thrombolytic therapy.
• Pre-existing evidence of unstable angina and myocardial infraction during the previous month, contraindications to the 6MWT.
• Subject, who in the opinion of the Investigator, is unsuitable to participate.

Sponsors & Collaborators

• SolAeroMed Inc.: lead

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

Post-Acute COVID-19 Syndrome

Interventions

perfluorooctylbromide and CO2 drug combination

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Montgomery, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Dennis, PhD

CONTACT

403-689-5989; jdennis@solaeromed.com

Francis Green, MBChB, MD

CONTACT

403-220-4514; fgreen@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 2, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share