NCT04734860

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

• Status: Withdrawn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 study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

Detailed description

This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	COVI-AMG	COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
DRUG	Placebo	Diluent solution

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-09-01
• Completion: 2021-11-01
• First posted: 2021-02-02
• Last updated: 2022-02-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study