NCT04454398

Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19

Detailed description

This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.

Conditions

• Covid-19

Interventions

Type	Name	Description
BIOLOGICAL	COVI-GUARD	COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
OTHER	Standard of Care	Standard of Care as determined by the Investigator
DRUG	Placebo	Diluent

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2020-07-01
• Last updated: 2021-01-08

Regulatory

• FDA-regulated drug study