Status:
UNKNOWN
Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
Lead Sponsor:
National Blood Center Foundation, Hemolife
Conditions:
Infections, Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and...
Detailed Description
This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and U...
Eligibility Criteria
Inclusion
- Over 18 years old
- Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
- Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
- The patient, or his representative, must sign an informed consent
Exclusion
- Participate in another clinical trial for CoViD- 19
- History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
- History of allergic reaction due to IgA deficiency
- Allergic reaction to sodium citrate or riboflavin (vitamin B2)
- History of immunosuppression
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04385186
Start Date
June 20 2020
End Date
December 30 2020
Last Update
June 2 2020
Active Locations (10)
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1
Clínica Antioquía
Medellín, Antioquía, Colombia, 0500
2
Clínica Sagrado Corazón
Medellín, Antioquía, Colombia, 0500
3
IPS Universitaria
Medellín, Antioquía, Colombia, 0500
4
Universidad de Antioquía
Medellín, Antioquía, Colombia, 0500