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

NCT04454398 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: GRD-COV-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Covid-19

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• AUC of COVI-GUARD (PK)

  Randomization through study completion through Day 60

• Cmax of COVI-GUARD (PK)

  Randomization through study completion through Day 60

• t½ of COVI-GUARD (PK)

  Randomization through study completion through Day 60

• Tmax of COVI-GUARD (PK)

  Randomization through study completion through Day 60

Study Arms (2)

COVI-GUARD

EXPERIMENTAL

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

Biological: COVI-GUARD; Other: Standard of Care

Placebo

PLACEBO COMPARATOR

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

Other: Standard of Care; Drug: Placebo

Interventions

COVI-GUARD BIOLOGICAL

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

Also known as: STI-1499

COVI-GUARD

Standard of Care OTHER

Standard of Care as determined by the Investigator

COVI-GUARD; Placebo

Placebo DRUG

Diluent

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

STI-2020; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 1, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01