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Convalescent Plasma for COVID-19 Pneumonia
NCT04345289Phase 3
Key facts
- Status
- Terminated
- Start
- May 2020
- Primary completion
- Mar 2021
- Countries
- 1
- Modality
- Biologic
- Conditions
- COVID-19 pneumonia
01
Overview
Phase 3, randomised, double-blind trial in COVID-19 pneumonia comparing Convalescent plasma with Infusion placebo (2 arms). Primary endpoint: All-cause mortality or need of invasive mechanical ventilation at 28 days. Started May 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Convalescent plasma
Single dose IV infusion of Convalescent anti-SARS-CoV-2 plasma (600 ml)
Infusion placebo
Single dose IV infusion of Saline 0.9% (600 ml)
03
Who it enrols
Adults with confirmed COVID-19 infection and evidence of pneumonia (hypoxia or radiographic findings) who are not pregnant or breastfeeding and not participating in other drug trials.
04
Endpoints
Primary
All-cause mortality or need of invasive mechanical ventilation
Secondary
Frequency of adverse events
Frequency of severe adverse events
Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
Ventilator-free days
Organ failure-free days
Duration of ICU stay
Mortality rate
Length of hospital stay
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