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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05372783

Run by

Sorrento Therapeutics, Inc.

People needed

0

Starts

2023-04-01

Expected to finish

2024-10-01

Last updated by the study team

2023-02-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ProSciento, Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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