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

Covid19 Clinical Trial

Official title:

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04734860
• Other study ID #: AMG-COV-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: November 2021

Study information

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

Clinical Trial Summary

This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

Description:

This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: September 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
• Mild symptoms consistent with a COVID-19 viral infection
• Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
• Willing to follow contraception guidelines

Exclusion Criteria:

• Evidence of moderate COVID-19 per FDA severity categorization
• Pregnant or lactating and breast feeding or planning on either during the study
• Has a documented infection other than COVID-19
• Has received a COVID-19 vaccine
• 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

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	Synergy Healthcare LLC	Bradenton	Florida
United States	Collaborative NeuroScience Research, LLC	Garden Grove	California
United States	Med-Care Research	Miami	Florida
United States	ETNA Medical Center	Tamarac	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 have remained out of the hospital or emergency room through Day 29	Proportion of subjects who have remained out of the hospital or emergency room through Day 29	Randomization to Day 29
Secondary	Viral load reduction from baseline to Day 8, 15, 29, 43, and 70	Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test	Randomization to Day 8, 15, 29, 43, 70
Secondary	Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70	Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70	Randomization to Day 43 and Day 70
Secondary	Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score	Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43	Randomization to Day 15, 29, 43
Secondary	Time to resolution of fever	For subjects who have a fever at randomization, time to resolution of the fever	Randomization through study completion at Day 70