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

NCT04734860 — Phase 2, Withdrawn, Sorrento Therapeutics, Inc.

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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

Registry	NCT04734860
Status	Withdrawn - A different study will be conducted.
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Sponsor	Sorrento Therapeutics, Inc. (Industry)
Conditions	Covid19
Interventions	COVI-AMG, Placebo (Biological, drug)
Dates	start 2021-04-01 (estimated), primary completion 2021-09-01 (estimated), completion 2021-11-01 (estimated), first posted 2021-02-02, last updated 2022-02-25
Locations	4 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
COVI-AMG	Experimental	Biological: COVI-AMG	A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Placebo	Placebo comparator	Drug: Placebo	A single injection of placebo will be administered

COVI-AMG (Biological), also known as STI-2020: COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Placebo (Drug): Diluent solution

+Outcome measures

Primary outcomes

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

Secondary outcomes

Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 [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
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 remained out of the hospital or emergency room through Day 43 and 70
Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score [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
Time to resolution of fever [Randomization through study completion at Day 70]: For subjects who have a fever at randomization, time to resolution of the fever

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
Collaborative NeuroScience Research, LLC	Garden Grove, California	United States
Synergy Healthcare LLC	Bradenton, Florida	United States
Med-Care Research	Miami, Florida	United States
ETNA Medical Center	Tamarac, Florida	United States

+Publications

Results publication: 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. PMID 34473343

+Investigators

Mike Royal, MD, Study director, Sorrento Therapeutics