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

NCT04738136 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-23

No results posted yet for this study

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

Interventions

DRUG

S-1226

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

Sponsors & Collaborators

  • SolAeroMed Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Montgomery, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738136 on ClinicalTrials.gov