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

Sponsor
Sorrento Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04906694
Collaborator
(none)
97
Enrollment
18
Locations
2
Arms
1.9
Actual Duration (Months)
5.4
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVI-DROPS
  • Drug: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 16, 2021
Actual Primary Completion Date :
Jan 13, 2022
Actual Study Completion Date :
Jan 13, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects who have COVID-19-related visit or hospitalization [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)

    Secondary Outcome Measures

    1. Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 [Baseline through Day 29]

      Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29

    2. Viral load change from baseline to D8 [Baseline to Day 8]

      Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)

    3. Change in WHO Clinical Progression Scale score [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)

    4. Viral load change from baseline to D29 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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-c onditions.html)

    • Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Sorrento Therapeutics, Inc.

    Investigators

    • Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sorrento Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04906694
    Other Study ID Numbers:
    • DRP-COV-201US
    First Posted:
    May 28, 2021
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sorrento Therapeutics, Inc.
    covid-19
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Feb 3, 2022