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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Biological: COVI-AMG; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research, LLC
  • Florida
    • Bradenton, Florida, United States, 34208
      • Synergy Healthcare LLC
    • Miami, Florida, United States, 33165
      • Med-Care Research
    • Tamarac, Florida, United States, 33321
      • ETNA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVI-AMG; A single injection of 40 mg, 100 mg, or 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: covid-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AMG-COV-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No