NCT04323800

Convalescent Plasma to Stem Coronavirus (CSSC-001)

Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Detailed description

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Conditions

• Coronavirus
• Convalescence

Interventions

Type	Name	Description
BIOLOGICAL	Anti- SARS-CoV-2 Plasma	SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
BIOLOGICAL	SARS-CoV-2 non-immune Plasma	Normal human plasma collected prior to December 2019

Timeline

• Start date: 2020-06-10
• Primary completion: 2021-04-22
• Completion: 2021-06-22
• First posted: 2020-03-27
• Last updated: 2022-04-26
• Results posted: 2022-04-22

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study