Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
- Registration Number
- NCT05372783
- Lead Sponsor
- Sorrento Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting < 5 days prior to screening visits
- Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity
- Willing and able to comply with study procedures and follow-up visits
- Willing to follow all contraception guidelines
- In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms
- Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study
- Has a prior history of long COVID
- Has a clinically documents acute infection other than COVID-19
- Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
- Has participated, or is participating in a clinical reserach study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IV immunoglobulin within 2 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STI-9199 STI-9199 4 mg, 10 mg or 20 mg STI-9199 administered intranasally Placebo Placebo Placebo administered intranasally
- Primary Outcome Measures
Name Time Method Change in viral load Baseline through Day 8 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
Incidence of adverse events (AEs) (safety) Baseline through study completion at up to 30 days 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
- Secondary Outcome Measures
Name Time Method Participant perceived disease progression Baseline through Day 15 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
Rate of COVID-19-related medical visits Baseline through Day 30 Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality
Change in viral load Baseline through Day 11 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
Patient rated response Baseline through D15 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
Trial Locations
- Locations (1)
ProSciento, Inc.
🇺🇸Chula Vista, California, United States