NCT04390503

Convalescent Plasma for Early Treatment of COVID-19

A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Andrew Eisenberger · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.

Detailed description

There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.

Conditions

• SARS-CoV 2
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Convalescent Plasma (anti-SARS-CoV-2 plasma)	Convalescent Plasma that contains antibody titers against SARS-CoV-2.
BIOLOGICAL	Control (albumin 5%)	Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.

Timeline

• Start date: 2021-03-12
• Primary completion: 2022-01-06
• Completion: 2022-01-06
• First posted: 2020-05-15
• Last updated: 2024-08-28
• Results posted: 2024-08-28

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study