TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients

Covid19 Clinical Trial

Official title:

TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716556
• Other study ID #: TSUNAMI
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Istituto Superiore di Sanità
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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 SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized to receive or not convalescent plasma. Patients in the plasma group will receive 200-300 ml of plasma collected by recovered patients with previous diagnosis of COVID19, plus standard therapy; Patients in the control group will receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening. Patients will be followed until day n30 from randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: May 31, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Covid19
• Pneumonia
• Pneumonia, Viral

Intervention

Biological:
• Convalescent plasma
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

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	SOD Malattie Infettive e Tropicali - AOU Careggi	Firenze
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	Milano
Italy	Ospedale Luigi Sacco	Milano
Italy	SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda	Milano
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

Sponsors (3)

Lead Sponsor	Collaborator
Istituto Superiore di Sanità	Agenzia Italiana del Farmaco, Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of CD4/CD8 ratio		14 days
Primary	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	Mortality rates	Mortality rates at 30 days	30 days
Secondary	Time to invasive mechanical ventilation or death	Days from randomization to invasive mechanical ventilation or death	30 days
Secondary	Time to virologic recover	Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)	30 days
Secondary	Hospitalization time		30 days
Secondary	Adverse events	occurrence of Adverse events	30 days