Status:
UNKNOWN
Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)
Lead Sponsor:
Hospital San Vicente Fundación
Collaborating Sponsors:
Clínica León XIII
Grupo de Inmunodeficiencias primarias Universidad de Antioquia
Conditions:
SARS-Cov-2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-...
Detailed Description
Coronavirus infection has been declared by the World Health Organization as a pandemic. In addition to hemodynamic and ventilatory support in the intensive care unit, there is no treatment for COVID-1...
Eligibility Criteria
Inclusion
- For plasma donors:
- Over 18 years of age
- Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
- If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.
- For plasma recipients:
- Over 18 years of age
- SARS-CoV-2 infection confirmed by PCR in any sample
- Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.
Exclusion
- For plasma donors:
- Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
- Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.
- For plasma receivers:
- Serious volume overload or other condition that contraindicates plasma transfusion.
- History of anaphylaxis or serious adverse reaction to plasma.
- Previous diagnosis of immunoglobulin A deficiency
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04391101
Start Date
June 1 2020
End Date
December 1 2021
Last Update
May 20 2020
Active Locations (1)
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1
Hospital San Vicente Fundacion
Medellín, Antioquia, Colombia