NCT05372783

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

May 10, 2022

Last Update Submit

February 9, 2023

Conditions

COVID-19

Keywords

covid-19

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in viral load

    Baseline through Day 11

  • Participant perceived disease progression

    Baseline through Day 15

  • Rate of COVID-19-related medical visits

    Baseline through Day 30

  • Patient rated response

    Baseline through D15

Study Arms (2)

STI-9199

EXPERIMENTAL

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

Drug: STI-9199

Placebo

PLACEBO COMPARATOR

Placebo administered intranasally

Drug: Placebo

Interventions

STI-9199DRUG

STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2

STI-9199
PlaceboDRUG

Diluent solution

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mike Royal, MD

    Sorrento Therapeutics, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 13, 2022

Study Start

April 1, 2023

Primary Completion

June 1, 2024

Study Completion

October 1, 2024

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

US(1)