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Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)

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.

Purpose of Study

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.

Eligibility

Age:
18 - 55
Sex:
All

Key Inclusion / Exclusion Criteria

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

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.

Conditions:

COVID-19

Status:

Completed

Phase:

Phase 2

Study ID

NCT04906694

Read Detailed Summary

Start Date / End Date:

16/11/2021 -

Enrollment:

97

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04906694

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17 Study Locations

United States

Epic Research
Red Oak, Texas, 75154
United States


Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501
United States


Remington Davis
Columbus, Ohio, 43215
United States


Cyn3rgy Research
Gresham, Oregon, 97030
United States


WR–ClinSearch
Chattanooga, Tennessee, 37421
United States


Advanced Medical Trials
Georgetown, Texas, 78628
United States


Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76051
United States


Centex Studies Inc. Houston
Houston, Texas, 77062
United States


LinQ
Pearland, Texas, 77584
United States


Clinical Neuroscience dba CNS Healthcare
Jacksonville, Florida, 32256
United States


Med–Care Research
Miami, Florida, 33165
United States


Clinical Neuroscience Solutions Healthcare
Orlando, Florida, 32801
United States


Precision Research Center
Tampa, Florida, 33614
United States


Clinical Site Partners, Inc
Winter Park, Florida, 32789
United States


Randomize Now
Peachtree City, Georgia, 30269
United States


Revival Research Institute
Dearborn, Michigan, 48126
United States


Future Innovative Treatments, LLC
Colorado Springs, Colorado, 80907
United States


Study Locations Map: