Status:
COMPLETED
Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
Fundacion Arturo Lopez Perez
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavi...
Eligibility Criteria
Inclusion
- Patient older than 18 years
- CALL score ≥ 9 (progression risk score)
- PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
- Any symptoms of COVID-19 infection
- Admission due to COVID-19 infection
- Signed informed consent
- ECOG before COVID-19 infection 0-2
Exclusion
- PaFi \<200 or mechanical ventilation indication
- Clinically relevant co-infection at admission
- Pregnancy or lactation
- IgA deficiency or IgA nephropathy
- Immunoglobulin or plasma administration in the last 60 days
- Contraindication to transfusion or previous allergy to blood-derived products
- Do-not-resuscitate status
- Patients receiving other investigational drug for COVID-19 in a clinical trial
- Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04375098
Start Date
May 4 2020
End Date
August 17 2020
Last Update
September 16 2020
Active Locations (1)
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1
Hospital Clínico Universidad Católica
Santiago, Chile