Status:
COMPLETED
Efficacy and Safety of COVID-19 Convalescent Plasma
Lead Sponsor:
Institute for Transfusion Medicine of RNM
Collaborating Sponsors:
University Clinic for Infectious Diseases, North Macedonia
Conditions:
Convalescent Plasma
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Detailed Description
There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Blood donors:
- Age: \>18 and \<60 years
- Body weight : \>55 kg
- Confirmed previous SARS CoV-2 infection
- Minimum 28 days after the last symptom or finishing of the isolation, or
- 21 day without symptoms from the date of the negative SARS CoV-2 test
- Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
- 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
- Patients/recipients:
- Age: \>18 years
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Patients with severe or immediately life-threatening COVID-19, or
- Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
- Informed consent provided by the patient or healthcare proxy
- Exclusion Criteria:
- Blood donors:
- Age : \<18 or \>60 years
- Female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
- Donors ineligible for regular voluntary blood donation
- Patients/recipients:
- Age : \<18 years
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- Patients who received in the past 30 days immunoglobulin therapy
- Females who are pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04397523
Start Date
April 30 2020
End Date
May 10 2021
Last Update
May 28 2024
Active Locations (1)
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1
Institute for Transfusion Medicine of RNM
Skopje, North Macedonia, 1000