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

• ClinicalTrials.gov Identifier: NCT04734860
• Recruitment Status: Withdrawn
• First Posted: February 2, 2021
• Last Update Posted: February 25, 2022
• Sponsor: Sorrento Therapeutics, Inc.
• Information provided by (Responsible Party): Sorrento Therapeutics, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Covid19	Biological: COVI-AMG; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: November 2021

Arms and Interventions

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 Name: STI-2020
Placebo Comparator: Placebo; A single injection of placebo will be administered	Drug: Placebo; Diluent solution

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects who have remained out of the hospital or emergency room through Day 29 [ Time Frame: Randomization to Day 29 ]
   Proportion of subjects who have remained out of the hospital or emergency room through Day 29

Secondary Outcome Measures :

1. Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 [ Time Frame: Randomization to Day 8, 15, 29, 43, 70 ]
   Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test
2. Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70 [ Time Frame: Randomization to Day 43 and Day 70 ]
   Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
3. Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score [ Time Frame: Randomization to Day 15, 29, 43 ]
   Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43
4. Time to resolution of fever [ Time Frame: Randomization through study completion at Day 70 ]
   For subjects who have a fever at randomization, time to resolution of the fever

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Collaborative NeuroScience Research, LLC

Garden Grove, California, United States, 92845

United States, Florida

Synergy Healthcare LLC

Bradenton, Florida, United States, 34208

Med-Care Research

Miami, Florida, United States, 33165

ETNA Medical Center

Tamarac, Florida, United States, 33321

Sponsors and Collaborators

Sorrento Therapeutics, Inc.

Investigators

• Study Director: Mike Royal, MD; Sorrento Therapeutics

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

• Responsible Party: Sorrento Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04734860
• Other Study ID Numbers: AMG-COV-201
• First Posted: February 2, 2021
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sorrento Therapeutics, Inc.:

covid-19

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases