Clinical trial NCT04906694: Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
Official title: A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of subjects who have COVID-19-related visit or hospitalization
timeFrame: Baseline through Day 29
Secondary outcomes:
measure: Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
timeFrame: Baseline through Day 29
measure: Viral load change from baseline to D8
timeFrame: Baseline to Day 8
measure: Change in WHO Clinical Progression Scale score
timeFrame: Baseline to Day 8 and Day 29
measure: Viral load change from baseline to D29
timeFrame: Baseline to Day 29
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Future Innovative Treatments, LLC
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience dba CNS Healthcare
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Healthcare
state: Florida
city: Tampa
country: United States
facility: Precision Research Center
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, Inc
state: Florida
city: Peachtree City
country: United States
facility: Randomize Now
state: Georgia
city: Dearborn
country: United States
facility: Revival Research Institute
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Columbus
country: United States
facility: Remington Davis
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Chattanooga
country: United States
facility: WR-ClinSearch
state: Tennessee
city: Georgetown
country: United States
facility: Advanced Medical Trials
state: Texas
city: Grapevine
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Houston
country: United States
facility: Centex Studies Inc. Houston
state: Texas
city: Pearland
country: United States
facility: LinQ
state: Texas
city: Red Oak
country: United States
facility: Epic Research
state: Texas
city: Lynchburg
country: United States
facility: Infectious Diseases Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: