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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04454398
• Other study ID #: GRD-COV-101
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2020
• Est. completion date: January 2021

Study information

• Verified date: January 2021
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

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

Other:
• Standard of Care
Standard of Care as determined by the Investigator

Drug:
• Placebo
Diluent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	All-cause mortality at 29 and 60 days	All-cause mortality at 29 and 60 days	Randomization through Day 29 and Day 60
Primary	Incidence of dose-limiting toxicities (safety)	Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions	Randomization through study completion through Day 60
Primary	Incidence of laboratory abnormalities (safety)	Clinically meaningful laboratory abnormalities	Randomization through study completion through Day 60
Primary	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
Primary	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
Primary	Anti-drug antibodies	Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD	Randomization through study completion through Day 60
Primary	Cytokine levels	Levels of cytokines including EGF, IFN?, IL-1ß, IL-6, IL-8, IL-10, and TNFa	Randomization through study completion through Day 60
Secondary	AUC of COVI-GUARD (PK)	Area under the serum concentration-time curve (AUC) of COVI-GUARD	Randomization through study completion through Day 60
Secondary	Cmax of COVI-GUARD (PK)	Maximum observed serum concentration (Cmax) of COVI-GUARD	Randomization through study completion through Day 60
Secondary	t½ of COVI-GUARD (PK)	Apparent serum terminal elimination half life (t½) of COVI-GUARD	Randomization through study completion through Day 60
Secondary	Tmax of COVI-GUARD (PK)	Time to Cmax (Tmax) of COVI-GUARD	Randomization through study completion through Day 60