NCT04370236

INB03 for the Treatment of Pulmonary Complications From COVID-19

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Inmune Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

Detailed description

The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection. Patients with COVID-19 infection and low blood oxygen levels with at least one high risk factor (see below) are eligible to participate in a 40-day study to determine whether INB03 can prevent the progression of pulmonary complications. Eligible participants will be randomized (1:1) to receive either INB03 + standard of care (SOC) or Placebo + SOC. Participants randomized to INB03 + SOC will receive a 1mg/kg injection of INB03 after randomization. Patients that remain in the hospital 7 days after the first dose will receive a second dose. A final safety visit will occur on Day 70.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	INB03	Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
DRUG	Placebo	Patients will receive up to two once per week subcutaneous injections of Placebo

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-10-13
• Completion: 2021-11-18
• First posted: 2020-04-30
• Last updated: 2022-03-18

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study