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

NCT ID: NCT04454398

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-01-31

Brief Summary

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

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.

Conditions

Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

COVI-GUARD

Intervention Type: BIOLOGICAL

COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein

Standard of Care

Intervention Type: OTHER

Standard of Care as determined by the Investigator

Placebo

Placebo administered via a single IV push injection, in addition to standard of care

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of Care as determined by the Investigator

Placebo

Intervention Type: DRUG

Diluent

Interventions

COVI-GUARD

COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein

Intervention Type: BIOLOGICAL

Standard of Care

Standard of Care as determined by the Investigator

Intervention Type: OTHER

Placebo

Diluent

Intervention Type: DRUG

Other Intervention Names

STI-1499

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Royal, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics

References

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

GRD-COV-101

Identifier Type: -

Identifier Source: org_study_id