Trials / Terminated
TerminatedNCT04900428
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 179 (actual)
- Sponsor
- Sorrento Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | COVI-DROPS | COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2 |
| DRUG | Placebo | Diluent solution |
Timeline
- Start date
- 2021-07-16
- Primary completion
- 2022-03-22
- Completion
- 2022-05-06
- First posted
- 2021-05-25
- Last updated
- 2023-01-30
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04900428. Inclusion in this directory is not an endorsement.