Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19

Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19

Study Overview

• Status: Withdrawn
• Conditions: Covid-19
• Intervention / Treatment: Other: Standard of Care; Biological: COVI-GUARD; Drug: Placebo

Detailed Description

This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.

• Study Type: Interventional
• Phase: 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:

• Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
• Willing and able to comply with study procedures and follow-up visits
• 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. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.

Exclusion Criteria:

• Clinical signs indicative of severe COVID-19
• Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
• Documented infection other than COVID-19
• Any medical condition that, in the Investigator's opinion, could adversely impact safety
• Pregnant or lactating women
• 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: Participants 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: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: COVI-GUARD; COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care	Other: Standard of Care; Standard of Care as determined by the Investigator; Biological: COVI-GUARD; COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein; Other Names: STI-1499
PLACEBO_COMPARATOR: Placebo; Placebo administered via a single IV push injection, in addition to standard of care	Other: Standard of Care; Standard of Care as determined by the Investigator; Drug: Placebo; Diluent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (safety)	Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD	Randomization through study completion through Day 60
Incidence of treatment-emergent adverse events (safety)	Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD	Randomization through study completion through Day 60
Incidence of serious adverse events (safety)	Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD	Randomization through study completion through Day 60
All-cause mortality at 29 and 60 days	All-cause mortality at 29 and 60 days	Randomization through Day 29 and Day 60
Incidence of dose-limiting toxicities (safety)	Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions	Randomization through study completion through Day 60
Incidence of laboratory abnormalities (safety)	Clinically meaningful laboratory abnormalities	Randomization through study completion through Day 60
SARS-CoV-2 viral load as assessed using various sample types	Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments	Randomization through study completion through Day 60
Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital	Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital	Randomization up to study completion through Day 60
Anti-drug antibodies	Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD	Randomization through study completion through Day 60
Cytokine levels	Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα	Randomization through study completion through Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of COVI-GUARD (PK)	Area under the serum concentration-time curve (AUC) of COVI-GUARD	Randomization through study completion through Day 60
Cmax of COVI-GUARD (PK)	Maximum observed serum concentration (Cmax) of COVI-GUARD	Randomization through study completion through Day 60
t½ of COVI-GUARD (PK)	Apparent serum terminal elimination half life (t½) of COVI-GUARD	Randomization through study completion through Day 60
Tmax of COVI-GUARD (PK)	Time to Cmax (Tmax) of COVI-GUARD	Randomization through study completion through 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): September 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• 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: GRD-COV-101

Drug and device information, study documents

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