Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
STI-9199 		4 mg, 10 mg or 20 mg STI-9199 administered intranasally
  • Drug: STI-9199
    STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Placebo Comparator
Placebo 		Placebo administered intranasally
  • Drug: Placebo
    Diluent solution

Recruiting Locations

More Details

NCT ID
NCT05372783
Status
Withdrawn
Sponsor
Sorrento Therapeutics, Inc.

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.