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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy protocol (STP) | Active Comparator | STP is defined as the best evidence based therapy approved for treatment of COVID-19 patients by Regional Health System emergency committee. STP could be updated during the trial. |
|
| STP + Standard Plasma (SP) | Experimental | STP + 3 units on day 1-3-5 of Standard Plasma collected in pre-COVID era (January-September 2019) |
|
| STP + COVID-19 Convalescent Plasma (CP) | Experimental | STP + 3 units on day 1-3-5 of COVID-19 Convalescent Plasma containing neutralizing SARS-Cov-2 antibodies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Therapy Protocol (STP) | Drug | Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-days survival | Proportion of patients alive 30 days after randomization | 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free survival | Cumulative incidence of mechanical ventilation or death | 30 days after randomization |
| 6-months survival | Probability of being alive at 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola Maria Manzini, MD | AO Città della salute e della scienza di Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO Città della salute e della scienza di Torino | Torino | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36418984 | Derived | Manzini PM, Ciccone G, De Rosa FG, Cavallo R, Ghisetti V, D'Antico S, Galassi C, Saccona F, Castiglione A, Birocco N, Francisci T, Hu H, Pecoraro C, Danielle F, Labanca L, Bordiga AM, Lorenzi M, Camisasca G, Giachino O, Pagliarino M, Ottone P, Scuvera ITD, Guaschino R, Freilone R, Berti P, Pittaluga F, Avolio M, Costa C, Raso S, Nucci A, Milan M, Baffa A, Russo A, Tornello A, Maddalena L, Delios G, Marletto FP, De Micheli AG, Mattei A, Baldassano S, Canta F, Russo ML, Bergamo D, Vitale F, Liccardi MM, Chinaglia A, Calcagno A, Converso M, Aldieri C, Libanore V, Blangetti I, Benedetti V, Mitola B, Scozzari G; PLACO COVID Study Group. Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial. BMC Infect Dis. 2022 Nov 22;22(1):879. doi: 10.1186/s12879-022-07716-5. |
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All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
Data will be available after 12 months from study ending and for the following 5 years
Data requests should be submitted to the corresponding author for consideration.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Three arms randomized trial, partially blinded
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Only the two experimental arms are masked. COVID-19 convalescent plasma (CP) and standard plasma (SP) will be masked and delivered to the wards in identical bags; a tag printed as "PLASMA TRIAL" will cover the actual name of the product
| STP + Standard Plasma (SP) | Other | Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP |
|
| STP + COVID-19 Convalescent Plasma (CP) | Other | Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP |
|
| 6 months after randomization |
| Incidence of complications | Proportion of patients developing any serious medical or procedure related complications | Within 12 months |
| Days in intensive care units (ICU) | Proportion of days spent in ICU on the total length of hospital stay | 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 | 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 | 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) | 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 | 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |