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

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

STI-9199

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring covid-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

ProSciento, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

STI-9199

Placebo

Arm Description

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

Placebo administered intranasally

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT05372783

First Posted

May 10, 2022

Last Updated

February 9, 2023

Sponsor

Sorrento Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05372783

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never launched

Study Start Date

April 2023 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

covid-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STI-9199

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered intranasally

Intervention Type

Drug

Intervention Name(s)

STI-9199

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Diluent solution

Primary Outcome Measure Information:

Title

Change in viral load

Description

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

Time Frame

Baseline through Day 8

Title

Incidence of adverse events (AEs) (safety)

Description

Time Frame

Baseline through study completion at up to 30 days

Secondary Outcome Measure Information:

Title

Change in viral load

Description

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

Time Frame

Baseline through Day 11

Title

Participant perceived disease progression

Description

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

Time Frame

Baseline through Day 15

Title

Rate of COVID-19-related medical visits

Description

Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality

Time Frame

Baseline through Day 30

Title

Patient rated response

Description

Time Frame

Baseline through D15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mike Royal, MD

Organizational Affiliation

Sorrento Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

ProSciento, Inc.

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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