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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COVI-DROPS
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19

Eligibility Criteria

18 Years - 55 Years (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
  • Either have no COVID-19 symptoms (asymptomatic) or mild symptoms
  • 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 this 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)
  • 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.
  • Has a documented infection other than COVID-19
  • Pregnant or lactating women who are breast feeding or planning on either during the study
  • Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
  • Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html)
  • Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.

Sites / Locations

  • Future Innovative Treatments, LLC
  • Clinical Neuroscience dba CNS Healthcare
  • Med-Care Research
  • Clinical Neuroscience Solutions Healthcare
  • Precision Research Center
  • Clinical Site Partners, Inc
  • Randomize Now
  • Revival Research Institute
  • Quality Clinical Research
  • Remington Davis
  • Cyn3rgy Research
  • WR-ClinSearch
  • Advanced Medical Trials
  • Precision Comprehensive Clinical Research Solutions
  • Centex Studies Inc. Houston
  • LinQ
  • Epic Research
  • Infectious Diseases Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-DROPS

Placebo

Arm Description

10, 20, or 40 mg of COVI-DROPS administered intranasally

2 mL administered intranasally

Outcomes

Primary Outcome Measures

Proportion of subjects who have COVID-19-related visit or hospitalization
Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)

Secondary Outcome Measures

Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Viral load change from baseline to D8
Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
Change in WHO Clinical Progression Scale score
Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Viral load change from baseline to D29
Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL)

Full Information

First Posted
May 26, 2021
Last Updated
January 21, 2022
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04906694
Brief Title
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
Official Title
A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

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
No

5. Study Description

Brief Summary
This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Detailed Description
Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
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
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVI-DROPS
Arm Type
Experimental
Arm Description
10, 20, or 40 mg of COVI-DROPS administered intranasally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 mL 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 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
Proportion of subjects who have COVID-19-related visit or hospitalization
Description
Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)
Time Frame
Baseline through Day 29
Secondary Outcome Measure Information:
Title
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Description
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time Frame
Baseline through Day 29
Title
Viral load change from baseline to D8
Description
Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
Time Frame
Baseline to Day 8
Title
Change in WHO Clinical Progression Scale score
Description
Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Time Frame
Baseline to Day 8 and Day 29
Title
Viral load change from baseline to D29
Description
Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL)
Time Frame
Baseline to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment Either have no COVID-19 symptoms (asymptomatic) or mild symptoms 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 this 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) 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. Has a documented infection other than COVID-19 Pregnant or lactating women who are breast feeding or planning on either during the study Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.
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
Future Innovative Treatments, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Neuroscience dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Clinical Neuroscience Solutions Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Precision Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Clinical Site Partners, Inc
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Randomize Now
City
Peachtree City
State/Province
Georgia
ZIP/Postal Code
30269
Country
United States
Facility Name
Revival Research Institute
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Remington Davis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
WR-ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Advanced Medical Trials
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Centex Studies Inc. Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
LinQ
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Epic Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
Infectious Diseases Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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