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Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19

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ClinicalTrials.gov Identifier: NCT04771351
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Study Description
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Brief Summary:
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Biological: COVI-AMG Drug: Placebo Phase 2

Detailed Description:
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: COVI-AMG 100 mg
A single injection of 100 mg of COVI-AMG will be administered.
 Biological: COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Other Name: STI-2020
Experimental: COVI-AMG 200 mg
A single injection of 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 Name: STI-2020
Placebo Comparator: Placebo
A single injection of placebo will be administered.
 Drug: Placebo
Diluent solution


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who are alive and free of respiratory failure at Day 29 [ Time Frame: Baseline through Day 29 ]
    Proportion of subjects who are alive and free of respiratory failure at Day 29


Secondary Outcome Measures :
  1. Viral load reduction [ Time Frame: Baseline to Day 4, 15, and 29 ]
    Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test

  2. Time to sustained clinical improvement [ Time Frame: Baseline through Day 29 ]
    Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29

  3. Proportion of subjects with clinical improvement [ Time Frame: Baseline to Day 15 and 29 ]
    Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29

  4. All-cause mortality at Day 29 [ Time Frame: Baseline through Day 29 ]
    All-cause mortality at Day 29


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive for COVID-19 by an approved antigen test
  • Progressive disease suggestive of ongoing COVID-19 infection
  • Requires hospitalization for acute medical care
  • Provides written informed consent
  • Willing to follow contraception guidelines during study

Exclusion Criteria:

  • Requires high-flow oxygen supplementation
  • Current or imminent respiratory failure
  • Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
  • Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
  • Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
  • Pregnant or lactating and breast feeding, or planning on either during the study
  • Unable to comply with planned study procedures and be available for all follow-up visits
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771351


Contacts
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Contact: Mike Royal, MD (858) 203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, Florida
Teradan Clinical Trials Recruiting
Brandon, Florida, United States, 33511
Contact: Daniel Lorch, MD         
Principal Investigator: Daniel Lorch, MD         
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics
More Information
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04771351    
Other Study ID Numbers: AMG-COV-202
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

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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