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Convalescent Plasma for Moderate and Severe COVID-19 (CPC-SARS)
NCT04405310Phase 2
Key facts
- Status
- Completed
- Start
- May 2020
- Primary completion
- Nov 2020
- Countries
- 1
- Sponsor
- Grupo Mexicano para el Estudio de la Medicina Intensiva
- Modality
- Biologic
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of convalescent plasma (Heinrich-Heine University, Duesseldorf) in coronavirus disease 2019 (COVID-19) (4 arms), sponsored by Grupo Mexicano para el Estudio de la Medicina Intensiva. Primary endpoint: Death at 15 days. Started May 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Moderate Disease - Plasma
Patients with Moderate (Phase II) COVID-19 receiving Convalescent Plasma + Conventional Therapy.
Moderate Disease - Placebo
Patients with Moderate (Phase II) COVID-19 receiving Placebo (Albumin) + Conventional Therapy.
Severe Disease - Plasma
Patients with Severe (Phase III) COVID-19 receiving Convalescent Plasma + Conventional Therapy.
Severe Disease - Placebo
Patients with Severe (Phase III) COVID-19 receiving Placebo (Albumin) + Conventional Therapy.
03
Who it enrols
Adult patients (18-70 years) with confirmed SARS-CoV-2 infection, presenting with moderate (Phase II) or severe (Phase III) disease, suspected cytokine release syndrome, and severe acute hypoxemia.
04
Endpoints
Primary
Death
Secondary
Length of stay ICU
Days of Mechanical Ventilation
Supplemental Oxigen support
Viral Load by RT-PCR
Inflamatory biomarkers
SOFA (sequencial Organ Failure Assesment)
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