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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

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Withdrawn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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.