Efficacy and Safety of COVID-19 Convalescent Plasma

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.

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