Status:
TERMINATED
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Lead Sponsor:
Centro Medico ABC
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
Detailed Description
We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patien...
Eligibility Criteria
Inclusion
- Donors:
- Age: \>18 and \<60 years
- Body weight : \>60 kg
- Confirmed previous SARS CoV-2 infection
- negative SARS CoV-2 test result
- 21 day without symptoms from the negative SARS CoV2 negative test
- Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- Positive COVID-19 IgG antibodies
- Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.
- Patients/recipients:
- Age: \>18 years
- Admitted to the ABC Medical Center facility for the treatment of COVID-19
- Patients with severe or critical COVID-19
- Informed consent provided by the patient or healthcare proxy
Exclusion
- Patients/recipients:
- 1\. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease
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Key Trial Info
Start Date :
August 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04432103
Start Date
August 8 2020
End Date
January 29 2021
Last Update
August 2 2021
Active Locations (1)
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1
Centro Medico Abc
Mexico City, Mexico, 01120