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

Primary Purpose

Covid19

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

COVI-AMG

Placebo

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-AMG

Placebo

Arm Description

A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.

A single injection of placebo will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.

Outcomes

Primary Outcome Measures

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

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

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

Incidence of dose-limiting toxicities (safety)

Safety as assessed by incidence of dose-limiting toxicities

Incidence of clinically meaningful laboratory abnormalities (safety)

Safety as assessed by incidence of clinically meaningful laboratory abnormalities

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

Time from onset of COVID-19 symptoms to treatment (Day 1)

Presence and levels of anti-drug antibodies directed to COVI-AMG

Cytokine levels post-treatment

Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA

Secondary Outcome Measures

AUC of COVI-AMG (PK)

Area under the serum concentration-time curve (AUC) of COVI-AMG

Cmax of COVI-AMG (PK)

Maximum observed serum concentration (Cmax) of COVI-AMG

Tmax of COVI-AMG (PK)

Time to Cmax (Tmax) of COVI-AMG

t½ of COVI-AMG (PK)

Apparent serum terminal elimination half life (t½) of COVI-AMG

Full Information

NCT ID

NCT04584697

First Posted

October 7, 2020

Last Updated

February 9, 2021

Sponsor

Sorrento Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04584697

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Different study will be conducted

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

covid-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Initially, 2 subjects will be enrolled at the 40 mg dose level. If no safety concerns arise, 48 subjects will then be randomized 1:1:1:1 to receive 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVI-AMG

Arm Type

Experimental

Arm Description

A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single injection of placebo will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.

Intervention Type

Biological

Intervention Name(s)

COVI-AMG

Other Intervention Name(s)

STI-2020

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Diluent solution

Primary Outcome Measure Information:

Title

Incidence of adverse events by type, frequency, severity, and causality (safety)

Description

Safety as assessed by incidence of adverse events by type, frequency, severity, and causality

Time Frame

Randomization through study completion at Day 60

Title

Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)

Description

Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality

Time Frame

Randomization through study completion at Day 60

Title

Incidence of serious adverse events by type, frequency, severity, and causality (safety)

Description

Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality

Time Frame

Randomization through study completion at Day 60

Title

Incidence of dose-limiting toxicities (safety)

Description

Safety as assessed by incidence of dose-limiting toxicities

Time Frame

Randomization through study completion at Day 60

Title

Incidence of clinically meaningful laboratory abnormalities (safety)

Description

Safety as assessed by incidence of clinically meaningful laboratory abnormalities

Time Frame

Randomization through study completion at Day 60

Title

Viral load as assessed using plasma and salivary samples at various timepoints

Description

Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing

Time Frame

Randomization through study completion at Day 60

Title

Time from onset of COVID-19 symptoms to treatment (Day 1)

Description

Time from onset of COVID-19 symptoms to treatment (Day 1)

Time Frame

Day 1

Title

Presence and levels of anti-drug antibodies directed to COVI-AMG

Description

Presence and levels of anti-drug antibodies directed to COVI-AMG

Time Frame

Randomization through study completion at Day 60

Title

Cytokine levels post-treatment

Description

Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA

Time Frame

Randomization through study completion at Day 60

Secondary Outcome Measure Information:

Title

AUC of COVI-AMG (PK)

Description

Area under the serum concentration-time curve (AUC) of COVI-AMG

Time Frame

Randomization through study completion at Day 60

Title

Cmax of COVI-AMG (PK)

Description

Maximum observed serum concentration (Cmax) of COVI-AMG

Time Frame

Randomization through study completion at Day 60

Title

Tmax of COVI-AMG (PK)

Description

Time to Cmax (Tmax) of COVI-AMG

Time Frame

Randomization through study completion at Day 60

Title

t½ of COVI-AMG (PK)

Description

Apparent serum terminal elimination half life (t½) of COVI-AMG

Time Frame

Randomization through study completion at Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mike Royal, MD

Organizational Affiliation

Sorrento Therapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

34473343

Citation

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.

Results Reference

derived

Learn more about this trial

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

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