Efficacy and Safety of COVID-19 Convalescent Plasma

Institute for Transfusion Medicine of RNM

Status: Completed

Conditions: COVID-19; Convalescent Plasma; SARS-CoV 2

Treatments: Biological: anti-SARS-CoV-2 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04397523

ITM05/2020MKD

Details and patient eligibility

About

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Full 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 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Hospitalized patients with SARS CoV-2 infection

Other group

Description:

Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma

Treatment:

Biological: anti-SARS-CoV-2 convalescent plasma