Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

Purpose

This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Positive for COVID-19 by an approved antigen test - Mild symptoms consistent with a COVID-19 viral infection - Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol - Willing to follow contraception guidelines

Exclusion Criteria

  • Evidence of moderate COVID-19 per FDA severity categorization - Pregnant or lactating and breast feeding or planning on either during the study - Has a documented infection other than COVID-19 - Has received a COVID-19 vaccine - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COVI-AMG 		A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
  • Biological: COVI-AMG
    COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
    Other names:
    • STI-2020
Placebo Comparator
Placebo 		A single injection of placebo will be administered
  • Drug: Placebo
    Diluent solution

Recruiting Locations

More Details

NCT ID
NCT04734860
Status
Withdrawn
Sponsor
Sorrento Therapeutics, Inc.

Detailed Description

This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.