Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19

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

This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.

Study Overview

• Status: Withdrawn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

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 days after dosing.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

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:

• Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented.
• Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization.
• Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol.
• Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.

Exclusion Criteria:

• Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study.
• Have any medical condition that, in the Investigator's opinion, could adversely impact safety.
• Be pregnant or lactating and breast feeding
• 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. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

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 given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.	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 given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.	Drug: Placebo; Diluent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events by type, frequency, severity, and causality (safety)	Safety as assessed by incidence of adverse events by type, frequency, severity, and causality	Randomization through study completion at Day 60
Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)	Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality	Randomization through study completion at Day 60
Incidence of serious adverse events by type, frequency, severity, and causality (safety)	Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality	Randomization through study completion at Day 60
Incidence of dose-limiting toxicities (safety)	Safety as assessed by incidence of dose-limiting toxicities	Randomization through study completion at Day 60
Incidence of clinically meaningful laboratory abnormalities (safety)	Safety as assessed by incidence of clinically meaningful laboratory abnormalities	Randomization through study completion at Day 60
Viral load as assessed using plasma and salivary samples at various timepoints	Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing	Randomization through study completion at Day 60
Time from onset of COVID-19 symptoms to treatment (Day 1)	Time from onset of COVID-19 symptoms to treatment (Day 1)	Day 1
Presence and levels of anti-drug antibodies directed to COVI-AMG	Presence and levels of anti-drug antibodies directed to COVI-AMG	Randomization through study completion at Day 60
Cytokine levels post-treatment	Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA	Randomization through study completion at Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of COVI-AMG (PK)	Area under the serum concentration-time curve (AUC) of COVI-AMG	Randomization through study completion at Day 60
Cmax of COVI-AMG (PK)	Maximum observed serum concentration (Cmax) of COVI-AMG	Randomization through study completion at Day 60
Tmax of COVI-AMG (PK)	Time to Cmax (Tmax) of COVI-AMG	Randomization through study completion at Day 60
t½ of COVI-AMG (PK)	Apparent serum terminal elimination half life (t½) of COVI-AMG	Randomization through study completion at Day 60

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): December 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

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-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No