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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

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Withdrawn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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.