NCT04354831

Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

Detailed description

This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	anti-SARS-CoV-2 convalescent plasma	* SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) * Study drug will be administered as a single intravenous infusion

Timeline

• Start date: 2020-05-11
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2020-04-21
• Last updated: 2024-04-10
• Results posted: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study