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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04771351
• Other study ID #: AMG-COV-202
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: October 2021

Study information

• Verified date: August 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Drug:
• Placebo
Diluent solution

Locations

Country	Name	City	State
United States	Teradan Clinical Trials	Brandon	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through Day 29
Secondary	Viral load reduction	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
Secondary	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	Baseline through Day 29
Secondary	Proportion of subjects with clinical improvement	Proportion of subjects with clinical improvement defined as =2 on the OSCI at Day 15 and Day 29	Baseline to Day 15 and 29
Secondary	All-cause mortality at Day 29	All-cause mortality at Day 29	Baseline through Day 29