NCT05074394

Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection

A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.

Detailed description

Subjects will be randomized 2:1 to receive a single dose of COVI-DROPS (40 mg) or placebo in a double-blind manner. Investigational product (COVI-DROP or placebo) will be administered once on Study Day 1 and followed to Day 29. Subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with COVID-19.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVI-DROPS	COVI-DROPS is a fully human monoclonal antibody that is a neutralizing antibody to SARS-CoV-2
DRUG	Placebo	Diluent solution

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Completion: 2023-01-01
• First posted: 2021-10-12
• Last updated: 2022-02-03

Regulatory

• FDA-regulated drug study