Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sorrento Therapeutics, Inc.
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.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
