NCT04400058

Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease

Conditions

• Covid-19

Interventions

Type	Name	Description
BIOLOGICAL	Octagam 10%	Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OTHER	Saline Solution	Placebo

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2020-05-22
• Last updated: 2024-01-18
• Results posted: 2024-01-18

Locations

22 sites across 3 countries: United States, Russia, Ukraine

Regulatory

• FDA-regulated drug study