Status:
WITHDRAWN
Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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-...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05372783
Start Date
April 1 2023
End Date
October 1 2024
Last Update
February 13 2023
Active Locations (1)
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1
ProSciento, Inc.
Chula Vista, California, United States, 91911