A Phase 2 interventional study of S-1226 (8%) and Placebo in Post Acute COVID-19 Syndrome, Long COVID and COVID-19 Respiratory Infection, sponsored by SolAeroMed Inc.. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by SolAeroMed Inc. · Phase 2, Interventional, and Treatment
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.
This is a randomized, placebo-controlled, phase II proof of concept study to evaluate the safety, tolerability and efficacy of S-1226 in Post-COVID-19 subjects (n≤48) with persistent respiratory symptoms.
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, vapor and liquid aerosol penetrates obstructed airways, resulting in rapid bronchodilation, enhanced blood oxygenation, improved mucus clearance and reduction of work of breathing.
Primary objective of this study is to evaluate the safety and tolerability of S-1226 composed of perflubron with 8% carbon dioxide in subjects with persistent post acute COVID-19 respiratory symptoms. The secondary objective is to establish proof of concept that S-1226 is effective in normalizing lung symptoms, including cough, breathlessness and lung function in subjects with persistent post-acute COVID-19 respiratory symptoms.
The study will consist of three parts: screening and randomization period, Treatment and evaluation, follow up period.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 48 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →SolAeroMed Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Subjects must meet the following criteria to be included in the study:
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
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%)
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
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
Placebo will delivered by inhalation of saline (0.9% NaCl) and Medical grade air.
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.
Time frame: 16 days
Normalization in 6-minute walk test (6MWT) distance
Changes in induced shortness of breath will be monitored using the 6 Minute walk test (6MWT) with continuous oxygen saturation (SpO2) monitoring . Normalization will be assessed by a return to normal distance values established in the literature.
Time frame: 16 days
Changes in percent predicted forced expiratory volume in 1 second
Change from baseline in percent of predicted forced expiratory volume in 1 Second (FEV1) will be calculated by measuring FEV1 at baseline and after treatment. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time frame: 16 days
Changes in from baseline in respiratory symptoms assessed by the St George's Respiratory Questionnaire (SGRQ).
St George's Respiratory Questionnaire (SGRQ), a two-part questionnaire that evaluates participant symptoms, including cough, (part 1) and activities and impact (part 2). Scores range from 0 to100 with higher scores indicating more limitations/perceived distress. Scores will be compared to the established minimally clinically important difference (MCID).
Time frame: 16 days
Change from baseline in Forced Vital Capacity.
Change from baseline in Forced Vital Capacity (FVC) will be measured. FVC is the total volume of air that can be exhaled during a maximal forced expiration effort.
Time frame: 16 days
Changes from baseline in Diffusing Lung Capacity
Changes from Baseline in Diffusing lung capacity (DLCO) will be measures. DLCO is a measurement used to evaluate the lungs ability to transfer gas from inspired air to the bloodstream.
Time frame: 16 days
Changes from baseline in Oxygen Saturation (SpO2)
Changes from baseline in percent of oxygen saturation (measured by pulse oximetry) will be calculated by measuring oxygen saturation before and up to 30 minutes after treatment.
Time frame: 16 days
Changes in from baseline in respiratory symptoms assessed by the modified Medical Research Council (mMRC) scale of dyspnea during daily activity.
The modified Medical Research Council (mMRC) scale of dyspnea used assess baseline and subsequent activity related dyspnea. Scores range from 0-4, with increasing scores representing greater difficulty in performing daily activities.
Time frame: 16 days
Changes in from baseline in respiratory symptoms assessed by the Borg Rating of Perceived Exertion (RPE) for dyspnea during exertion.
Borg Rating of Perceived Exertion (RPE) a categorical scale used to assess dyspnea during exertion. The lowest score, 6, represents No exertion/effort at all while the highest score of 20 represents absolute maximal effort/exhaustion.
Time frame: 16 days
Changes in from baseline in respiratory symptoms assessed by Visual Analogue Scale (VAS) for dyspnea while at rest.
A 10 cm Visual Analogue Scale (VAS) to assess participant dyspnea while at rest at the time of Assessment. Three delineations will be placed on the scale (0 being no dyspnea, 5 (middle) and 10 being max dyspnea) for participants to mark with a cross.
Time frame: 16 days
No study locations are listed for this record.
Plan to share: No
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SolAeroMed Inc.