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

August 15, 2022 updated by: Sorrento Therapeutics, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Brandon, Florida, United States, 33511
        • Teradan Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • STI-2020
Placebo Comparator: Placebo
A single injection of placebo will be administered.
Drug: Placebo
Diluent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to Day 4, 15, and 29
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
Baseline through Day 29
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
Baseline to Day 15 and 29
All-cause mortality at Day 29
Time Frame: Baseline through Day 29
All-cause mortality at Day 29
Baseline through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorrento Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMG-COV-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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