NCT04771351

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

A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19

• Status: Withdrawn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 a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. 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: 2021-08-01
• Completion: 2021-10-01
• First posted: 2021-02-25
• Last updated: 2022-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study