COVID-19
Conditions
Keywords
covid-19
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.
Interventions
DRUGSTI-9199
STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
DRUGPlacebo
Diluent solution
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed