To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.
500-700 ml of Plasma will be collected by apheresis from COVID recovered donors showing the
presence of neutralizing antibodies to SARS-Cov-2 (anti-SARS-Cov-2). All plasma will be
screened for transmissible diseases according to italian law (Hepatitis B Virus,Hepatitis C
Virus, Human Immunodeficiency Virus 1-2, Syphilis) plus adjunctive screening for Hepatitis A
Virus and Hepatitis E Virus-RNA and Parvovirus B19-DNA as requested from Italian National
Blood Authority. Apheresis will be divided in two/three units (170-300 ml each), virus
inactivated with Riboflavin and ultraviolet light illumination technology and immediately
frozen and stored separately from other plasma bags.
Enrolled patients will be stratified according to severity of respiratory failure and
randomized in three arms: 1) Standard Therapy Protocol (STP), 2) Standard Therapy Protocol +
170-350 ml standard Plasma (SP) on day 1-3-5 after randomization, 3) Standard Therapy
Protocol + 170-350 ml COVID-19 Convalescent Plasma on day 1-3-5 after randomization.
The three therapeutic units of COVID-19 Convalescent plasma will be chosen in order to
minimize variations among patients in the total amount of infused SARS-Cov-2 antibodies.
Drug: Standard Therapy Protocol (STP)
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee
Other: STP + Standard Plasma (SP)
Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP
Other: STP + COVID-19 Convalescent Plasma (CP)
Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP
Inclusion Criteria:
- Confirmed SARS-Cov-2 diagnosis by RT-PCR on nasopharyngeal swab or on bronchoalveolar
lavage
- Respiratory failure onset or progression within 5 days
- Signed Informed Consent
Exclusion Criteria:
- Pregnancy
- Previous severe reactions to plasma transfusion
- Unavailability of blood group compatible COVID-19 convalescent plasma
AO Città della salute e della scienza di Torino
Torino, Italy
Paola Maria Manzini, MD, Principal Investigator
AO Città della salute e della scienza di Torino