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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04584697
• Other study ID #: AMG-COV-102
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 2020
• Est. completion date: April 2021

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn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

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb).

Drug:
• Placebo
Diluent solution

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 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
Primary	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
Primary	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
Primary	Incidence of dose-limiting toxicities (safety)	Safety as assessed by incidence of dose-limiting toxicities	Randomization through study completion at Day 60
Primary	Incidence of clinically meaningful laboratory abnormalities (safety)	Safety as assessed by incidence of clinically meaningful laboratory abnormalities	Randomization through study completion at Day 60
Primary	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
Primary	Time from onset of COVID-19 symptoms to treatment (Day 1)	Time from onset of COVID-19 symptoms to treatment (Day 1)	Day 1
Primary	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
Primary	Cytokine levels post-treatment	Cytokine levels post-treatment including EGF, IFN?, IL-1ß, IL-6, IL-8, IL-10, and TNFa will be measured by ELISA	Randomization through study completion at Day 60
Secondary	AUC of COVI-AMG (PK)	Area under the serum concentration-time curve (AUC) of COVI-AMG	Randomization through study completion at Day 60
Secondary	Cmax of COVI-AMG (PK)	Maximum observed serum concentration (Cmax) of COVI-AMG	Randomization through study completion at Day 60
Secondary	Tmax of COVI-AMG (PK)	Time to Cmax (Tmax) of COVI-AMG	Randomization through study completion at Day 60
Secondary	t½ of COVI-AMG (PK)	Apparent serum terminal elimination half life (t½) of COVI-AMG	Randomization through study completion at Day 60