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

Sorrento Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Covid19

Treatments: Biological: COVI-AMG; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04584697

AMG-COV-102

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

COVI-AMG

Experimental group

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.

Treatment:

Biological: COVI-AMG

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo