NCT04906694

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 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 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.

Conditions

• Covid19

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: 2021-11-16
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2021-05-28
• Last updated: 2022-02-03

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study