Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
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 an option for treatment of COVID-19. Experience from prior outbreaks
with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma
can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole
blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for
donation according to the Institutional protocol. Recipients will be COVID-19 patients
requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be
infused and recipients will be followed up.
Biological: anti-SARS-CoV-2 convalescent plasma
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Inclusion Criteria
Blood donors:
1. Age: >18 and <60 years
2. Body weight : >55 kg
3. Confirmed previous SARS CoV-2 infection
4. Minimum 28 days after the last symptom or finishing of the isolation, or
5. 21 day without symptoms from the date of the negative SARS CoV-2 test
6. Written informed consent to participate in this clinical trial, to donate plasma and
to store the specimen for future testing.
7. 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)
8. Male donors, or female donors who have not been pregnant, or female donors who have
been pregnant tested negative for HLA antibodies
9. Individuals who meet all regular voluntary donor eligibility requirements
Patients/recipients:
1. Age: >18 years
2. Admitted to an acute care facility for the treatment of COVID-19 complications
3. Patients with severe or immediately life-threatening COVID-19, or
4. Patients who are judged by a healthcare provider to be at high risk of progression to
severe or life-threatening disease.
5. Informed consent provided by the patient or healthcare proxy
Exclusion Criteria:
Blood donors:
1. Age : <18 or >60 years
2. Female subjects who are pregnant
3. HIV1,2 hepatitis B,C or syphilis infection
4. Donors ineligible for regular voluntary blood donation
Patients/recipients:
1. Age : <18 years
2. Contraindication to transfusion (severe volume overload, history of anaphylaxis to
blood products)
3. Patients who received in the past 30 days immunoglobulin therapy
4. Females who are pregnant or breastfeeding
Institute for Transfusion Medicine of RNM
Skopje, North Macedonia