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

NCT04584697 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: AMG-COV-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• Incidence of dose-limiting toxicities (safety)

  Safety as assessed by incidence of dose-limiting toxicities

  Randomization through study completion at Day 60

• Incidence of clinically meaningful laboratory abnormalities (safety)

  Safety as assessed by incidence of clinically meaningful laboratory abnormalities

  Randomization through study completion at Day 60

• 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

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

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

  Day 1

• 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

• 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

  Randomization through study completion at Day 60

Secondary Outcomes (4)

• AUC of COVI-AMG (PK)

  Randomization through study completion at Day 60

• Cmax of COVI-AMG (PK)

  Randomization through study completion at Day 60

• Tmax of COVI-AMG (PK)

  Randomization through study completion at Day 60

• t½ of COVI-AMG (PK)

  Randomization through study completion at Day 60

Study Arms (2)

COVI-AMG

EXPERIMENTAL

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.

Biological: COVI-AMG

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

COVI-AMG BIOLOGICAL

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

Also known as: STI-2020

COVI-AMG

Placebo DRUG

Diluent solution

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

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

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02