A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Overview
- Phase
- Phase 2
- Intervention
- COVI-DROPS
- Conditions
- Covid19
- Sponsor
- Sorrento Therapeutics, Inc.
- Enrollment
- 97
- Locations
- 18
- Primary Endpoint
- Proportion of subjects who have COVID-19-related visit or hospitalization
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 either asymptomatic or have mild symptoms.
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.
Investigators
Eligibility 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 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.
Arms & Interventions
COVI-DROPS
10, 20, or 40 mg of COVI-DROPS administered intranasally
Intervention: COVI-DROPS
Placebo
2 mL administered intranasally
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects who have COVID-19-related visit or hospitalization
Time Frame: Baseline through Day 29
Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)
Secondary Outcomes
- Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29(Baseline through Day 29)
- Viral load change from baseline to D8(Baseline to Day 8)
- Change in WHO Clinical Progression Scale score(Baseline to Day 8 and Day 29)
- Viral load change from baseline to D29(Baseline to Day 29)