Status:
COMPLETED
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 ei...
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 placeb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04906694
Start Date
November 16 2021
End Date
January 13 2022
Last Update
February 3 2022
Active Locations (18)
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1
Future Innovative Treatments, LLC
Colorado Springs, Colorado, United States, 80907
2
Clinical Neuroscience dba CNS Healthcare
Jacksonville, Florida, United States, 32256
3
Med-Care Research
Miami, Florida, United States, 33165
4
Clinical Neuroscience Solutions Healthcare
Orlando, Florida, United States, 32801