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Purpose

This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment - Either have no COVID-19 symptoms (asymptomatic) or mild symptoms - 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 must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity - Willing to follow contraception guidelines

Exclusion Criteria

  • In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) - Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process. - Has a documented infection other than COVID-19 - Pregnant or lactating women who are breast feeding or planning on either during the study - 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 - Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical -conditions.html) - Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COVI-DROPS 		10, 20, or 40 mg of COVI-DROPS administered intranasally
  • Biological: COVI-DROPS
    COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
    Other names:
    • STI-2099
Placebo Comparator
Placebo 		2 mL administered intranasally
  • Drug: Placebo
    Diluent solution

Recruiting Locations

More Details

NCT ID
NCT04906694
Status
Completed
Sponsor
Sorrento Therapeutics, Inc.

Detailed Description

Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.

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.