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

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 2
Locations
United States
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:

  • 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

Sites / Locations

  • Teradan Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

COVI-AMG 100 mg

COVI-AMG 200 mg

Placebo

Arm Description

A single injection of 100 mg of COVI-AMG will be administered.

A single injection of 200 mg of COVI-AMG will be administered.

A single injection of placebo will be administered.

Outcomes

Primary Outcome Measures

Proportion of subjects who are alive and free of respiratory failure at Day 29
Proportion of subjects who are alive and free of respiratory failure at Day 29

Secondary Outcome Measures

Viral load reduction
Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test
Time to sustained clinical improvement
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
Proportion of subjects with clinical improvement
Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29
All-cause mortality at Day 29
All-cause mortality at Day 29

Full Information

First Posted
February 23, 2021
Last Updated
August 15, 2022
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04771351
Brief Title
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
A different study will be conducted.
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
October 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
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.
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.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVI-AMG 100 mg
Arm Type
Experimental
Arm Description
A single injection of 100 mg of COVI-AMG will be administered.
Arm Title
COVI-AMG 200 mg
Arm Type
Experimental
Arm Description
A single injection of 200 mg of COVI-AMG will be administered.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single injection of 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
Proportion of subjects who are alive and free of respiratory failure at Day 29
Description
Proportion of subjects who are alive and free of respiratory failure at Day 29
Time Frame
Baseline through Day 29
Secondary Outcome Measure Information:
Title
Viral load reduction
Description
Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test
Time Frame
Baseline to Day 4, 15, and 29
Title
Time to sustained clinical improvement
Description
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
Time Frame
Baseline through Day 29
Title
Proportion of subjects with clinical improvement
Description
Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29
Time Frame
Baseline to Day 15 and 29
Title
All-cause mortality at Day 29
Description
All-cause mortality at Day 29
Time Frame
Baseline through Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States

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

Learn more about this trial

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

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