Status:
TERMINATED
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ 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 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) wi...
Eligibility Criteria
Inclusion
- Positive for COVID-19 with any locally approved RT-PCR within 7 days of planned treatment.
- Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
- Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
- Subject must have provided written informed consent
- Willing to follow contraception guidelines
Exclusion
- Moderate or severe illness/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 subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
- Documented acute infection other thand COVID-19
- Pregnant or lactating women who are breast feeding or planning to during the study
- Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, 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
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2022
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04900428
Start Date
July 16 2021
End Date
May 6 2022
Last Update
January 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals of Coventry and Warwickshire Hospital Trust
Coventry, United Kingdom