Status:
UNKNOWN
Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
TecSalud Investigación Clínica
Instituto Nacional de Enfermedades Respiratorias
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. T...
Detailed Description
A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive: Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 h...
Eligibility Criteria
Inclusion
- Adults 18 years of age and older.
- Confirmed SARS-CoV2 infection
- Hospitalized for COVID 19
- Severe disease or risk for severe disease
- Informed consent from patient or responsible person.
Exclusion
- History of allergic reactions to blood products
- SOFA scale \>12 points
- Absolute contraindication for administration of plasma
- Participation in other blinded clinical trial
- Projected life expectancy less than 3 months
- Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT04388410
Start Date
August 25 2020
End Date
December 31 2020
Last Update
August 26 2020
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Tlalpan, Mexico, 14000