TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
1 other identifier
interventional
474
1 country
48
Brief Summary
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with pneumonia due to SARS-CoV-2 will be randomized to receive or not convalescent plasma collected by recovered patients with previous diagnosis of COVID19
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jul 2020
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2020
CompletedFirst Submitted
Initial submission to the registry
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedAugust 26, 2021
August 1, 2021
6 months
January 14, 2021
August 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who meet invasive mechanical ventilation or death
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 \<150 or death
at 30 days
Secondary Outcomes (5)
Mortality rates
30 days
Time to invasive mechanical ventilation or death
30 days
Time to virologic recover
30 days
Hospitalization time
30 days
Adverse events
30 days
Other Outcomes (1)
Evaluation of CD4/CD8 ratio
14 days
Study Arms (2)
Standard Therapy+Convalescent Plasma
EXPERIMENTALPatients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.
Standard Therapy
NO INTERVENTIONPatients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications
Interventions
Convalescent plasma will be collected by healthy donors, recovered by COVID19 and, after standard preparation and dosage of neutralizing antibodies, it will be administered to patients with SARS-CoV2 pneumonia
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (\<= 10 days) according to the following definitions:
- Suggestive radiological imaging (CT, RX, ultrasound);
- Respiratory failure not fully explained by heart failure or fluid overload;
- PaO2/FiO2 200-350 mmHg;
- Signed informed consent
You may not qualify if:
- need of non invasive or invasive mechanical ventilation at the time of randomization;
- PaO2/FiO2 \<200;
- patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
- patients who expressly refuse to adhere the clinical study;
- use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
- patients participating to other clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Superiore di Sanitàlead
- Gruppo Italiano Malattie EMatologiche dell'Adultocollaborator
- Agenzia Italiana del Farmacocollaborator
Study Sites (48)
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
Ancona, Italy
Ospedale di Arezzo
Arezzo, Italy
Clinica Malattie Infettive, Università degli Studi di Bari
Bari, Italy
Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
Bergamo, Italy
UOC Malattie Infettive - AOU Bologna
Bologna, Italy
UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele
Catania, Italy
Ospedale Città di Castello
Città di Castello, Italy
Ospedale di Empoli
Empoli, Italy
UOC Malattie Infettive - ASUR Marche Area Vasta 4
Fermo, Italy
UOC Malattie Infettive - AOU Ferrara
Ferrara, Italy
Ospedale Santa Maria Annunziata
Florence, Italy
SOD Malattie Infettive e Tropicali - AOU Careggi
Florence, Italy
Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia
Foggia, Italy
Nuovo Ospedale S. Giovanni Battista Usl Umbria2
Foligno, Italy
U.O.C. Malattie Infettive ASL Frosinone
Frosinone, Italy
U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino
Genova, Italy
Ospedale di Grosseto
Grosseto, Italy
ASL 5 Spezzina - SC Malattie Infettive
La Spezia, Italy
ASST Lecco - Malattie Infettive
Lecco, Italy
Ospedale di Livorno
Livorno, Italy
Ospedale di Lucca
Lucca, Italy
S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma
Mantova, Italy
Ospedale Dell'Angelo - UOC Malattie Infettive
Mestre, Italy
ASST Santi Paolo e Carlo
Milan, Italy
Ospedale Luigi Sacco
Milan, Italy
SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale San Gerardo
Monza, Italy
Malattie Infettive - AOU Federico II di Napoli
Napoli, Italy
UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
Napoli, Italy
UOC Malattie Infettive e Tropicali - AOU Policlinico
Palermo, Italy
Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliero-Universitaria di Perugia
Perugia, Italy
UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord
Pesaro, Italy
AOU Pisana
Pisa, Italy
Ospedale Pistoia
Pistoia, Italy
Ospedale Prato
Prato, Italy
Malattie Infettive Ravenna
Ravenna, Italy
UOC Malattie Infettive - AUSL Reggio Emilia
Reggio Emilia, Italy
Malattie Infettive - Rimini Forlì Cesena
Rimini, Italy
Campus Bio Medico - UO Anestesia e Rianimazione
Roma, Italy
ASL 1 Imperiese - SC Malattie Infettive
Sanremo, Italy
ASL 2 Savonese - SC Malattie Infettive
Savona, Italy
Ospedale di Siena
Siena, Italy
Ospedale di Sondrio - dipartimento di Medicina
Sondrio, Italy
AOU di Terni
Terni, Italy
Ospedale Ca Foncello - UOC Malattie Infettive
Treviso, Italy
A.O. Integrata Università di Verona
Verona, Italy
Ospedale Viareggio
Viareggio, Italy
Related Publications (1)
Menichetti F, Popoli P, Puopolo M, Spila Alegiani S, Tiseo G, Bartoloni A, De Socio GV, Luchi S, Blanc P, Puoti M, Toschi E, Massari M, Palmisano L, Marano G, Chiamenti M, Martinelli L, Franchi S, Pallotto C, Suardi LR, Luciani Pasqua B, Merli M, Fabiani P, Bertolucci L, Borchi B, Modica S, Moneta S, Marchetti G, d'Arminio Monforte A, Stoppini L, Ferracchiato N, Piconi S, Fabbri C, Beccastrini E, Saccardi R, Giacometti A, Esperti S, Pierotti P, Bernini L, Bianco C, Benedetti S, Lanzi A, Bonfanti P, Massari M, Sani S, Saracino A, Castagna A, Trabace L, Lanza M, Focosi D, Mazzoni A, Pistello M, Falcone M; TSUNAMI Study group. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136246. doi: 10.1001/jamanetworkopen.2021.36246.
PMID: 34842924DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 20, 2021
Study Start
July 16, 2020
Primary Completion
January 14, 2021
Study Completion
May 31, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08