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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring covid-19
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.
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)
Time from onset of COVID-19 symptoms to treatment (Day 1)
Presence and levels of anti-drug antibodies directed to COVI-AMG
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
No
Product Manufactured in and Exported from the U.S.
No
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
No
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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