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

Sorrento Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Drug: STI-9199; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372783

SHLD-COV-201

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

STI-9199

Experimental group

Description:

4 mg, 10 mg or 20 mg STI-9199 administered intranasally

Treatment:

Drug: STI-9199

Placebo

Placebo Comparator group

Description:

Placebo administered intranasally

Treatment:

Drug: Placebo