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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee
Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP
Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP
AO Città della salute e della scienza di Torino
Torino, Italy
30-days survival
Proportion of patients alive 30 days after randomization
Time frame: 30 days after randomization
Ventilator free survival
Cumulative incidence of mechanical ventilation or death
Time frame: 30 days after randomization
6-months survival
Probability of being alive at 6 months after randomization
Time frame: 6 months after randomization
Incidence of complications
Proportion of patients developing any serious medical or procedure related complications
Time frame: Within 12 months
Days in intensive care units (ICU)
Proportion of days spent in ICU on the total length of hospital stay
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months
Positivity for Immunoglobulin G to SARS-Cov-2
Proportion of patients showing seroconversion to Immunoglobulin G (IgG) anti-SARS-Cov-2
Time frame: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months
Clearance of viral load
Proportion of patients showing viral clearance by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on plasma and respiratory tract samples
Time frame: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months
Sequential Organ Failure Assessment (SOFA) score
Variations in SOFA Score (range 0-24; higher score mean a worse outcome)
Time frame: On day 0, 2, 4, 6, 10, 14, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months
Any variation from Standard Therapy Protocol
Proportion of patients needing introduction of new drug or discontinuation of drug from standard therapy protocol
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed daily up to 2 months
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