Clinical trial NCT05372783: Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
Official title: A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in viral load
timeFrame: Baseline through Day 8
measure: Incidence of adverse events (AEs) (safety)
timeFrame: Baseline through study completion at up to 30 days
Secondary outcomes:
measure: Change in viral load
timeFrame: Baseline through Day 11
measure: Participant perceived disease progression
timeFrame: Baseline through Day 15
measure: Rate of COVID-19-related medical visits
timeFrame: Baseline through Day 30
measure: Patient rated response
timeFrame: Baseline through D15
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc.
state: California
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: