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

COVID-19 Clinical Trial

Official title:

A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05372783
• Other study ID #: SHLD-COV-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2023
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-19 positive with mild to moderate symptoms.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• STI-9199
STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
• Placebo
Diluent solution

Locations

Country	Name	City	State
United States	ProSciento, Inc.	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load	Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection	Baseline through Day 8
Primary	Incidence of adverse events (AEs) (safety)	Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	Baseline through study completion at up to 30 days
Secondary	Change in viral load	Change in viral load from baseline to Day 4, Day 11 and Day 15 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection	Baseline through Day 11
Secondary	Participant perceived disease progression	Participants rate their progression of disease on Day 8 and Day 15 when asked "Have your COVID symptoms gotten worse since treatment?" Yes or No response	Baseline through Day 15
Secondary	Rate of COVID-19-related medical visits	Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality	Baseline through Day 30
Secondary	Patient rated response	Proportion of participants scoring = +1 and those scoring = -1 using a patient global impression of change (PGIC) 7-point categorical scale on Day 8 and Day 15 when responding to the question "In terms of your COVID-19 symptoms, how much benefit if any did you receive from the treatment?" The 7-point scale range is -3 to +3 where -3 is "very much worse" to +3 "very much improved" based on how the participant feels post-treatment	Baseline through D15