This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
ProSciento, Inc.
Chula Vista, California, United States
Change in viral load
Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Time frame: Baseline through Day 8
Incidence of adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time frame: Baseline through study completion at up to 30 days
Change in viral load
Change in viral load from baseline to Day 4, Day 11 and Day 15 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Time frame: Baseline through Day 11
Participant perceived disease progression
Participants rate their progression of disease on Day 8 and Day 15 when asked "Have your COVID symptoms gotten worse since treatment?" Yes or No response
Time frame: Baseline through Day 15
Rate of COVID-19-related medical visits
Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality
Time frame: Baseline through Day 30
Patient rated response
Proportion of participants scoring ≥ +1 and those scoring ≤ -1 using a patient global impression of change (PGIC) 7-point categorical scale on Day 8 and Day 15 when responding to the question "In terms of your COVID-19 symptoms, how much benefit if any did you receive from the treatment?" The 7-point scale range is -3 to +3 where -3 is "very much worse" to +3 "very much improved" based on how the participant feels post-treatment
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Time frame: Baseline through D15