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

January 21, 2022 updated by: Sorrento Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Future Innovative Treatments, LLC
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience dba CNS Healthcare
      • Miami, Florida, United States, 33165
        • Med-Care Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions Healthcare
      • Tampa, Florida, United States, 33614
        • Precision Research Center
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, Inc
    • Georgia
      • Peachtree City, Georgia, United States, 30269
        • Randomize Now
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revival Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington Davis
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch
    • Texas
      • Georgetown, Texas, United States, 78628
        • Advanced Medical Trials
      • Grapevine, Texas, United States, 76051
        • Precision Comprehensive Clinical Research Solutions
      • Houston, Texas, United States, 77062
        • Centex Studies Inc. Houston
      • Pearland, Texas, United States, 77584
        • LinQ
      • Red Oak, Texas, United States, 75154
        • Epic Research
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Infectious Diseases Associates of Central Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: COVI-DROPS
10, 20, or 40 mg of COVI-DROPS administered intranasally
Biological: COVI-DROPS
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Other Names:
  • STI-2099
PLACEBO_COMPARATOR: Placebo
2 mL administered intranasally
Drug: Placebo
Diluent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who have COVID-19-related visit or hospitalization
Time Frame: Baseline through Day 29
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)
Baseline through Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time Frame: Baseline through Day 29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Baseline through Day 29
Viral load change from baseline to D8
Time Frame: Baseline to Day 8
Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
Baseline to Day 8
Change in WHO Clinical Progression Scale score
Time Frame: Baseline to Day 8 and Day 29
Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Baseline to Day 8 and Day 29
Viral load change from baseline to D29
Time Frame: Baseline to Day 29
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)
Baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorrento Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2021

Primary Completion (ACTUAL)

January 13, 2022

Study Completion (ACTUAL)

January 13, 2022

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (ACTUAL)

May 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRP-COV-201US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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