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Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
COVI-AMG
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
  • No medical or psychiatric conditions that could put the subject at risk
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Clinical signs of COVID-19 indicative of impending hospitalization
  • Documented infection in addition to COVID-19 that requires systemic treatment
  • Medical condition that could adversely impact safety, in the Investigator's opinion
  • Is or planning to be pregnant or lactating
  • 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 received or will receive during study participation a vaccine for COVID-19
  • Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    COVI-AMG

    Placebo

    Arm Description

    40 mg, 100 mg, or 200 mg of COVI-AMG will be administered

    Placebo will be administered

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events by type, frequency, severity, and causality (safety)
    Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
    Changes in viral shedding from Baseline to Day 15
    Changes in viral shedding from Baseline to Day 15

    Secondary Outcome Measures

    Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
    Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
    Time to viral RNA negativity
    Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
    Time to resolution of symptoms
    Time to resolution of symptoms as assessed by the COVID-19 PRO instrument

    Full Information

    First Posted
    February 2, 2021
    Last Updated
    February 9, 2022
    Sponsor
    Sorrento Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04738175
    Brief Title
    Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
    Official Title
    A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    A different study will be conducted.
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    November 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
    Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
    Detailed Description
    Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

    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 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COVI-AMG
    Arm Type
    Experimental
    Arm Description
    40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo will be administered
    Intervention Type
    Biological
    Intervention Name(s)
    COVI-AMG
    Other Intervention Name(s)
    STI-2020
    Intervention Description
    COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Diluent solution
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events by type, frequency, severity, and causality (safety)
    Description
    Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
    Time Frame
    Randomization through study completion at Day 70
    Title
    Changes in viral shedding from Baseline to Day 15
    Description
    Changes in viral shedding from Baseline to Day 15
    Time Frame
    Randomization to Day 15
    Secondary Outcome Measure Information:
    Title
    Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
    Description
    Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
    Time Frame
    Randomization to Day 8, 29, 43, 70
    Title
    Time to viral RNA negativity
    Description
    Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
    Time Frame
    Randomization through study completion at Day 70
    Title
    Time to resolution of symptoms
    Description
    Time to resolution of symptoms as assessed by the COVID-19 PRO instrument
    Time Frame
    Randomization through study completion at Day 70

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization No medical or psychiatric conditions that could put the subject at risk Willing to follow contraception guidelines Exclusion Criteria: Clinical signs of COVID-19 indicative of impending hospitalization Documented infection in addition to COVID-19 that requires systemic treatment Medical condition that could adversely impact safety, in the Investigator's opinion Is or planning to be pregnant or lactating 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 received or will receive during study participation a vaccine for COVID-19 Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
    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

    Learn more about this trial

    Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

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