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Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection (US)

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

COVI-DROPS

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID19, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for "mild" states as follows: "Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging."
Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll
A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination
Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
Willing to follow contraception guidelines

Exclusion Criteria:

In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection
Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection
Has an active documented infection other than COVID-19
Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process
Pregnant or lactating women who are breast feeding or planning on either during the study
Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study
Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-DROPS

Placebo

Arm Description

40 mg of COVI-DROPS administered intranasally

2 mL placebo administered intranasally

Outcomes

Primary Outcome Measures

Proportion of subjects who have a COVID-19-related visit or hospitalization

Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29)

Secondary Outcome Measures

Viral load change from baseline to Day 15 (D15)

Viral load change from baseline to D15 based on nasal quantitative reverse transcription polymerase chain reaction (RT-PCR) COVID-19 viral titers (Log-10 copies/mL). Includes viral load change for subjects in the unvaccinated/no prior infection group as well as the vaccinated/prior infection group

Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups

For each of the unvaccinated/no prior infection group or the vaccinated/prior infection group, proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through D29

Full Information

NCT ID

NCT05074394

First Posted

October 7, 2021

Last Updated

January 21, 2022

Sponsor

Sorrento Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05074394

Brief Title

Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection

Acronym

Official Title

A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Withdrawn

Why Stopped

to be replaced with a different protocol

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

January 2023 (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 prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.

Detailed Description

Subjects will be randomized 2:1 to receive a single dose of COVI-DROPS (40 mg) or placebo in a double-blind manner. Investigational product (COVI-DROP or placebo) will be administered once on Study Day 1 and followed to Day 29. Subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with COVID-19.

6. Conditions and Keywords

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

COVID-19

Keywords

COVID19, 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

COVI-DROPS

Arm Type

Experimental

Arm Description

40 mg of COVI-DROPS administered intranasally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 mL placebo administered intranasally

Intervention Type

Biological

Intervention Name(s)

COVI-DROPS

Other Intervention Name(s)

STI-2099

Intervention Description

COVI-DROPS is a fully human monoclonal antibody that is a neutralizing antibody to SARS-CoV-2

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Diluent solution

Primary Outcome Measure Information:

Title

Proportion of subjects who have a COVID-19-related visit or hospitalization

Description

Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29)

Time Frame

Baseline through Day 29

Secondary Outcome Measure Information:

Title

Viral load change from baseline to Day 15 (D15)

Description

Time Frame

Baseline through Day 15

Title

Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups

Description

Time Frame

Baseline to Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for "mild" states as follows: "Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging." Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity Willing to follow contraception guidelines Exclusion Criteria: In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection Has an active documented infection other than COVID-19 Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process Pregnant or lactating women who are breast feeding or planning on either during the study Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 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

12. IPD Sharing Statement

Learn more about this trial

Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection

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