CSSC-001: Convalescent Plasma to Stem Coronavirus: A Randomized Controlled Double-Blinded Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune plasma) Among Adults Exposed to COVID-19

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. Adults 18 years of age and older with high-risk exposure and at higher risk for severe illness or health care personnel with high-risk exposure may participate. We will randomize 150 eligible subjects in a 1:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma). Read more about the CSSC-001 trial.

CSSC-004: Convalescent Plasma to Limit Coronavirus-Associated Complications: A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune) Plasma Among Outpatients with Symptomatic COVID-19 

This randomized, double-blind, controlled, phase 2 trial will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms, and duration of nasopharyngeal or oropharyngeal viral shedding. Adults 18 years of age or older, regardless of risk factors for severe illness, may participate. Approximately 1,344 eligible subjects stratified 50:50 in the <65 vs. ≥65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma. Read more about the CSSC-004 trial.

CSSC-004: Convalescent Plasma to Limit Coronavirus-Associated Complications
A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune) Plasma Among Outpatients with Symptomatic COVID-19

This randomized, double-blind, controlled, phase 2 trial will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms, and duration of nasopharyngeal or oropharyngeal viral shedding. Adults 18 years of age or older, regardless of risk factors for severe illness, may participate. Approximately 1,344 eligible subjects stratified 50:50 in the <65 vs. ≥65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

ClinicalTrials.gov Identifier:
NCT04373460

NOTICE: Online training and downloadable documentation for the CSSC 001 and 004 Trials has been moved to https://biostraining.com/COVID/. Please register for the new site for access to these. Any already completed trainings will be filed in the eTMF and do not need to be re-taken. 

Convalescent Plasma to Stem Coronavirus: A Randomized Controlled Double-Blinded Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune plasma) Among Adults Exposed to COVID-19 (CSSC-001)

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. Adults 18 years of age and older with high-risk exposure and at higher risk for severe illness and/or who are health care personnel with high-risk exposure may participate. We will randomize 150 eligible subjects in a 1:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

ClinicalTrials.gov Identifier:
NCT04323800

NOTICE: Online training and downloadable documentation for the CSSC 001 and 004 Trials has been moved to https://biostraining.com/COVID/. Please register for the new site for access to these. Any already completed trainings will be filed in the eTMF and do not need to be re-taken. 

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