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

Sponsor
Sorrento Therapeutics, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04738175
Collaborator
(none)
0
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVI-AMG
  • Drug: Placebo
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: COVI-AMG

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

Biological: COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Other Names:
  • STI-2020

    		•
    Placebo Comparator: Placebo

    Placebo will be administered

    Drug: Placebo
    Diluent solution

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events by type, frequency, severity, and causality (safety) [Randomization through study completion at Day 70]

      Safety as assessed by incidence of adverse events by type, frequency, severity, and causality

    2. Changes in viral shedding from Baseline to Day 15 [Randomization to Day 15]

      Changes in viral shedding from Baseline to Day 15

    Secondary Outcome Measures

    1. Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 [Randomization to Day 8, 29, 43, 70]

      Changes in viral shedding from Baseline to Day 8, 29, 43, and 70

    2. Time to viral RNA negativity [Randomization through study completion at Day 70]

      Time to viral RNA negativity using nasopharyngeal reverse transcription PCR

    3. Time to resolution of symptoms [Randomization through study completion at Day 70]

      Time to resolution of symptoms as assessed by the COVID-19 PRO instrument

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sorrento Therapeutics, Inc.

    Investigators

    • Study Director: Mike Royal, MD, Sorrento Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sorrento Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04738175
    Other Study ID Numbers:
    • AMG-COV-201-BR
    First Posted:
    Feb 4, 2021
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 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 25, 2022