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Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

Primary Purpose

Covid-19

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
COVI-GUARD
Standard of Care
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19

Eligibility Criteria

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

Inclusion Criteria:

  • Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
  • Willing and able to comply with study procedures and follow-up visits
  • Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.

Exclusion Criteria:

  • Clinical signs indicative of severe COVID-19
  • Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
  • Documented infection other than COVID-19
  • Any medical condition that, in the Investigator's opinion, could adversely impact safety
  • Pregnant or lactating women
  • 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. Note: Participants who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    COVI-GUARD

    Placebo

    Arm Description

    COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care

    Placebo administered via a single IV push injection, in addition to standard of care

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events (safety)
    Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
    Incidence of treatment-emergent adverse events (safety)
    Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
    Incidence of serious adverse events (safety)
    Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
    All-cause mortality at 29 and 60 days
    All-cause mortality at 29 and 60 days
    Incidence of dose-limiting toxicities (safety)
    Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
    Incidence of laboratory abnormalities (safety)
    Clinically meaningful laboratory abnormalities
    SARS-CoV-2 viral load as assessed using various sample types
    Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
    Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
    Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
    Anti-drug antibodies
    Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
    Cytokine levels
    Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα

    Secondary Outcome Measures

    AUC of COVI-GUARD (PK)
    Area under the serum concentration-time curve (AUC) of COVI-GUARD
    Cmax of COVI-GUARD (PK)
    Maximum observed serum concentration (Cmax) of COVI-GUARD
    t½ of COVI-GUARD (PK)
    Apparent serum terminal elimination half life (t½) of COVI-GUARD
    Tmax of COVI-GUARD (PK)
    Time to Cmax (Tmax) of COVI-GUARD

    Full Information

    First Posted
    June 30, 2020
    Last Updated
    January 6, 2021
    Sponsor
    Sorrento Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04454398
    Brief Title
    Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
    Official Title
    A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Difficulty recruiting
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    January 2021 (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
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
    Detailed Description
    This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COVI-GUARD
    Arm Type
    Experimental
    Arm Description
    COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo administered via a single IV push injection, in addition to standard of care
    Intervention Type
    Biological
    Intervention Name(s)
    COVI-GUARD
    Other Intervention Name(s)
    STI-1499
    Intervention Description
    COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard of Care as determined by the Investigator
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Diluent
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events (safety)
    Description
    Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    Incidence of treatment-emergent adverse events (safety)
    Description
    Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    Incidence of serious adverse events (safety)
    Description
    Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    All-cause mortality at 29 and 60 days
    Description
    All-cause mortality at 29 and 60 days
    Time Frame
    Randomization through Day 29 and Day 60
    Title
    Incidence of dose-limiting toxicities (safety)
    Description
    Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
    Time Frame
    Randomization through study completion through Day 60
    Title
    Incidence of laboratory abnormalities (safety)
    Description
    Clinically meaningful laboratory abnormalities
    Time Frame
    Randomization through study completion through Day 60
    Title
    SARS-CoV-2 viral load as assessed using various sample types
    Description
    Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
    Time Frame
    Randomization through study completion through Day 60
    Title
    Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
    Description
    Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
    Time Frame
    Randomization up to study completion through Day 60
    Title
    Anti-drug antibodies
    Description
    Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    Cytokine levels
    Description
    Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
    Time Frame
    Randomization through study completion through Day 60
    Secondary Outcome Measure Information:
    Title
    AUC of COVI-GUARD (PK)
    Description
    Area under the serum concentration-time curve (AUC) of COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    Cmax of COVI-GUARD (PK)
    Description
    Maximum observed serum concentration (Cmax) of COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    t½ of COVI-GUARD (PK)
    Description
    Apparent serum terminal elimination half life (t½) of COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60
    Title
    Tmax of COVI-GUARD (PK)
    Description
    Time to Cmax (Tmax) of COVI-GUARD
    Time Frame
    Randomization through study completion through Day 60

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing Willing and able to comply with study procedures and follow-up visits Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used. Exclusion Criteria: Clinical signs indicative of severe COVID-19 Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours Documented infection other than COVID-19 Any medical condition that, in the Investigator's opinion, could adversely impact safety Pregnant or lactating women 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. Note: Participants who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Royal, MD
    Organizational Affiliation
    Sorrento Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34473343
    Citation
    Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
    Results Reference
    derived

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    Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

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